National Advisory Committee on Immunization (NACI): Meetings

Meetings are closed to the public, but a summary of discussion is provided below for each meeting.

Upcoming meetings

April 16-17, 2024
June 11-12, 2024
September 18-19, 2024
November 19-20, 2024

Past meetings:

February 2024

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) February 23, 2024
Agenda item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the virtual meeting and invited any new declarations of interest as they pertain to the agenda.
Inclusive language for pregnancy and breastfeeding For Decision	The NACI Secretariat provided an overview of evidence, expert engagements, and proposed approach for inclusive language strategies for pregnancy and breastfeeding vaccine recommendations across NACI statements. Following the presentation, the committee discussed additive language options. The approved language will be applied in the Canadian Immunization Guide chapter updates and future NACI statements, including the RSV infant statement.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) February 7-8, 2024
Agenda item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest as they pertain to the agenda.
Health Canada Updates For Information	Health Canada provided updates for vaccines in various review and approval stages.
COVID-19: 2024 spring program for individuals at high-risk of severe illness For Discussion and Decision	The NACI Secretariat provided an overview of evidence and considerations for an additional COVID-19 booster dose in the Spring of 2024 for individuals at high-risk of severe illness. The Working Group Chair presented the proposed recommendations from the COVID-19 Vaccine Working Group. Following the presentation, the committee engaged in discussion and deliberation on the proposed recommendations. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee and will re-circulate to NACI for further input and approval.
COVID-19: Updated recommendations on the use of Novavax COVID-19 vaccine For Decision	The NACI Secretariat provided an overview of the policy questions and summary of evidence for the Novavax Nuvaxovid COVID-19 vaccines (original and updated XBB.1.5). The COVID-19 Working Group Chair presented proposed recommendations from the Working Group. Following the presentation, the committee engaged in discussion and deliberation on the use of this vaccine relative to other available options, and also the schedule. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee and will re-circulate to NACI for further input and approval.
RSV: NACI Final Review of Recommendations for products to prevent Respiratory Syncytial Virus (RSV) disease in infants (Nirsevimab and RSVpreF) For Decision	The NACI Secretariat presented a summary of the clinical, economic and programmatic considerations on the use of Nirsevimab and RSVpreF vaccine to protect infants. The RSV Working Group Chair presented proposed recommendations from the Working Group for a final discussion. Following the presentation, the committee engaged in discussion and deliberation on the proposed recommendations. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee and will re-circulate to NACI for further input and approval.
Mpox: Interim guidance on the use of Imvamune^®in the context of a routine immunization program For Decision	The NACI Secretariat provided an overview of the proposed updates to previous NACI guidance on the use of Imvamune for prevention of Mpox in outbreak settings. The Mpox Working Group Chair presented proposed recommendations from the Working Group to consider the merits of a routine immunization program. Following the presentation, the committee engaged in discussion and deliberation on the proposed recommendations. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee and will re-circulate to NACI for further input and approval.
Liaison and Ex-officio representatives: Updates of activities For Information	NACI liaison and ex-officio representatives provided written and verbal updates on key emerging and ongoing topics of interest to NACI, from the perspective of their respective organizations.
HPV: NACI First Review of Updated recommendations on Human papillomavirus infection (HPV) vaccine schedules For Information and Discussion	The NACI Secretariat presented clinical evidence and key considerations on HPV vaccine schedules. In addition, an academic from L'Université Laval provided an overview of Canadian-specific disease modelling that was commissioned by PHAC to support NACI decisions. The Working Group Chair presented proposed recommendations from the HPV Working Group. Following the presentation, the committee engaged in discussion of the evidence, recommendations, and next steps. The committee will discuss again at an April 2024 virtual NACI meeting. Draft recommendations will incorporate feedback from the meeting, and CIC consultation will also be arranged.
Secretariat Updates For Information	The NACI Executive Secretary provided updates on files in progress.
NACI 2024-2026 Workplan For Information and Discussion	The NACI Executive Secretary provided an overview of proposed 2024-2026 workplan items based on consultation results from NACI and the provinces and territories via the Canadian Immunization Committee (CIC). Following the presentation, the committee engaged in discussion on the proposed workplan items. The NACI Secretariat will finalize a proposed workplan for 2024-2026 in discussion with the NACI Executive Committee. Once approved by PHAC senior management, a workplan will be published on the NACI website in Spring/Summer 2024. The workplan will balance new product submissions with other immunization public health priorities.
National Immunization Strategy (NIS) For Information	PHAC presented a summary of key results from the input received from NACI for the NIS 2025-2031 renewal. Following the presentation, the committee engaged in discussion and provided additional input. PHAC provided an overview of next steps for NIS renewal consultation.

November 2023

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) November 15-16, 2023
Agenda item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the virtual meeting and invited any new declarations of interest as they pertain to the agenda.
Health Canada Updates For Information	Health Canada provided updates for vaccines in various review and approval stages.
COVID-19: 2024 spring program for individuals at high-risk of severe illness For Discussion and Decision	The NACI Secretariat provided an overview of evidence and considerations for an additional COVID-19 booster dose in the Spring of 2024 for individuals at high-risk of severe illness. The Working Group Chair presented the proposed recommendations from the COVID-19 Vaccine Working Group. Following the presentation, the committee engaged in discussion and deliberation on the proposed recommendations. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee and will re-circulate to NACI for further input and approval.
Secretariat Updates For Information	The NACI Executive Secretary provided updates on files in progress.
Pneumococcal: Pediatric risk groups and catch up program (PCV15 and PCV 20) For Discussion and Decision	The NACI Secretariat provided an overview of additional considerations for the use of PCV15 and PCV20 for pediatric populations at increased risk of invasive pneumococcal disease. Following the presentation, the committee engaged in discussion and deliberation on the proposed recommendations for pediatric risk groups and catch up program. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee and will re-circulate to NACI for further input and final approval.
RSV: Recommendations for Products to Prevent RSV Disease in Infants (Nirsevimab and RSVpreF (Abrysvo)) For Information and Discussion	The NACI Secretariat provided an overview of evidence and considerations for Respiratory Syncytial Virus (RSV) vaccines. The Working Group Chair presented the proposed recommendations from RSV Working Group. Following the presentation, the committee engaged in discussion of the evidence, recommendations and next steps. The committee will discuss again at the February 2024 NACI meeting and the draft statement will go to the Canadian Immunization Committee (CIC) for input in the interim.

September 2023

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) September 27-28, 2023
Agenda item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the in-person meeting and invited any new declarations of interest as they pertain to the agenda.
Health Canada updates For Information	Health Canada provided updates for vaccines in various review and approval stages.
Influenza: Statement on seasonal influenza vaccine for 2024-2025 For Discussion and Decision	The NACI Secretariat provided an overview of changes to the 2024-2025 seasonal influenza statement proposed by the NACI Influenza Working Group. The Working Group Chair presented the proposed recommendations from the Influenza Working Group. Following the presentation, the committee engaged in discussion and deliberation on the proposed recommendations. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee and will re-circulate to NACI for further input and approval.
Influenza: Analysis of influenza vaccine product choices for older adults 65 years of age and older For Discussion and Decision	The NACI Secretariat provided an overview of the key considerations for the review of safety and efficacy/effectiveness of influenza vaccines in adults 65 years of age, considering recommendations for preferred products in this age group. The Influenza Working Group Chair presented the proposed recommendations from the Working Group. Following the presentation, the committee engaged in discussion and deliberation on the proposed recommendations. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee and will re-circulate to NACI for further input and approval.
Pneumococcal: PCV15 and PCV20 pediatric recommendations For Discussion and Decision	The NACI Secretariat provided an overview of the risk factors associated with invasive pneumococcal disease in children and adults, and summarized economic considerations based on a PHAC model and economic evaluation. The Pneumococcal Working Group Chair presented an overview of Working Group deliberations and proposed recommendations. Following the presentation, the committee engaged in discussion and deliberation on the proposed recommendations for PCV15 and PCV20. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee and will re-circulate to NACI for further input and approval.
National Immunization Strategy (NIS) renewal For Information	PHAC provided an overview of the National Immunization Strategy (NIS) and outlined the goals and process for the 2025-2030 NIS renewal plan as well as NACI's role in this engagement.
Secretariat updates For Information	The NACI Executive Secretary provided an update on the NACI forward agenda and the upcoming 2024-2026 workplan prioritization process.
COVID: Simplified schedule for previously unvaccinated For Discussion and Decision	The NACI Secretariat provided an overview of the key considerations to the COVID-19 vaccine schedule for individuals who are not yet vaccinated, considering recently authorised schedules. The COVID-19 Working Group Chair presented the proposed recommendations from the Working Group. Following the presentation, the committee engaged in discussion and deliberation on the proposed recommendations. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee and will re-circulate to NACI for further discussion and approval. PHAC will seek to brief provinces and territories as soon as possible to facilitate rollout planning.
Economics Task Group: Interpretation guide For Information	The NACI Secretariat provided an overview of the health economics interpretation guide for decision-makers, a tool developed by PHAC which will accompany the NACI Guidelines for economic evaluation of vaccination programs in Canada, currently published online.
Liaison and Ex-officio representatives: Updates of activities For Information	NACI liaison and ex-officio representatives provided written and verbal updates on key emerging and ongoing issues of interest to NACI, from the perspective of their respective organizations.

July 2023

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) July 11, 2023
Agenda item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest as they pertain to the agenda.
PHAC and Health Canada updates For Information	The NACI Secretariat provided some information about upcoming matters that are of interest to the committee, and Health Canada also provided updates on various vaccine submissions.
COVID-19 update and forward plan For Discussion	The NACI Secretariat provided an update on upcoming COVID-19 vaccine products pending regulatory review and the forward plan for the committee to discuss. The committee agreed to a provide clarification on its advice as needed, as regulatory decisions are made for this fall.
NACI pediatric pneumococcal vaccine program recommendations For Information and Discussion	The NACI Secretariat provided a follow up evidence overview from the June 6 meeting, where the committee started reviewing the evidence for PNEU-C-15 and PNEU-C-20 vaccination to prevent invasive pneumococcal disease in children. Following the presentation, the committee engaged in discussion on the evidence presented and next steps for this guidance, pending regulatory decisions.

June 2023

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) June 5-6, 2023
Agenda item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest as they pertain to the agenda.
Health Canada Regulatory Update For Information	Health Canada provided updates on COVID-19 vaccine submissions.
Prevention of invasive meningococcal disease (IMD) outbreaks among individuals aged 15 to 24 years For Discussion and Decision	The NACI Secretariat provided an overview of the evidence for risk of invasive meningococcal disease (IMD) by age in Canada, with a focus on recent outbreaks among 15- to 24-year-olds. The Meningococcal Working Group Chair presented considerations from the IMD Working Group on the current risk groups to consider for immunization programs, based on recent epidemiology. Following the presentation, the committee deliberated on proposed revisions to risk groupings. The NACI Secretariat will update proposed risk descriptions to reflect decisions by the committee and will re-circulate to NACI for further discussion and approval.
Guidance for 2023 fall COVID-19 vaccine program For Discussion and Decision	The NACI Secretariat provided an overview of the context, evidence, and considerations on the target populations for a COVID-19 booster program starting in fall 2023. The COVID-19 Working Group Chair presented the proposed recommendations from the Working Group. Following the presentation, the committee engaged in discussion and deliberation on the proposed recommendations. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee and will re-circulate to NACI for further discussion and approval.
NACI pediatric pneumococcal vaccine program recommendations For Information and Discussion	The NACI Secretariat provided a summary of evidence for PNEU-C-15 and PNEU-C-20 vaccination to prevent invasive pneumococcal disease (IPD) in children. The Pneumococcal Working Group Chair presented the policy questions to be considered by NACI in upcoming deliberations as well as the Working Group's current assessment of the evidence and recommendations for healthy children and children at increased risk of disease. Following the presentation, the committee engaged in discussion on the evidence and next steps.
Secretariat Updates For Information	The NACI Executive Secretary provided an update on the NACI forward workplan and membership.

April 2023

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) April 27-28, 2023
Agenda item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the in-person meeting and invited any new declarations of interest. The Vice-Presidents of the Infections Diseases and Vaccination Programs Branch at PHAC provided remarks to the committee, expressing recognition and appreciation for NACI's work over the course of the COVID-19 pandemic response.
Health Canada Regulatory Update For Information	Health Canada provided updates for vaccines in various review and approval stages.
Influenza Working Group workplan and project update (analysis of influenza vaccine product choices for older adults 65+) For Information	The NACI Secretariat provided an update on the Influenza Working Group (IWG) ongoing projects and activities, and an overview of the key considerations for the IWG's ongoing analysis of the optimal use of influenza vaccines in older adults.
Review of safety and effectiveness of influenza vaccine in pregnancy For Discussion and Decision	The NACI Secretariat provided an overview of the key considerations and discussions to date for the review of safety and effectiveness of influenza vaccine in pregnancy and presented the proposed recommendations from the IWG. Following the presentation, the committee engaged in discussion and deliberation on the proposed recommendations. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee and will re-circulate to NACI for further discussion and approval.
Day 1 closing remarks	The NACI Chair extended a warm welcome to the PHAC President and the Chief Public Health Officer (CPHO), who expressed their gratitude and recognition for NACI's exceptional efforts during the COVID-19 pandemic response. The committee's dedication was acknowledged as they were praised for their ongoing commitment and diligence in addressing not only COVID-related matters but also their unwavering efforts in tackling various other important issues related to Vaccine Preventable Diseases (VPD).
Novavax COVID-19 vaccine as a primary series for adolescents (12 to 17 years of age), and booster doses for adults (18 years of age) For Discussion and Decision	The NACI Secretariat provided a summary of evidence, considerations, and COVID-19 Working Group discussions on the use of the COVID-19 Novavax Nuvaxovid vaccine as a primary series in adolescents 12-17 years of age and as a booster dose for adults 18 years and older. The Working Group Chair presented the proposed recommendations from the COVID-19 Working Group. Following the presentation, the committee engaged in discussion and deliberation on the proposed recommendations. The NACI Secretariat will update proposed recommendations within the Canadian Immunization Guide (CIG) COVID-19 Chapter to reflect decisions by the committee.
COVID-19 bivalent mRNA booster vaccine as primary series For Discussion and Decision	The NACI Secretariat provided a summary of evidence regarding the use of bivalent mRNA COVID-19 vaccines as a primary series across age groups, which has been discussed at previous NACI meetings. The Working Group Chair presented the proposed recommendations from the COVID-19 Working Group. Following the presentation, the committee engaged in discussion and deliberation on the proposed recommendations. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee and will re-circulate to NACI for further discussion and approval.
COVID-19 vaccine fall booster planning For Information and Discussion	The NACI Secretariat provided an overview of proposed evidence and policy questions to be considered by NACI in upcoming discussions on the 2023 COVID-19 vaccine fall booster program guidance. Following the presentation, the committee engaged in discussion on proposed evidence reviews and policy questions. NACI planning advice is expected in summer 2023.
Liaison and Ex-officio representatives: Updates of activities For Information	NACI liaison and ex-officio representatives provided written and verbal updates on key emerging and ongoing issues of interest to NACI, from the perspective of their respective organizations.
NACI Secretariat updates on workplan and GRADE integration For Information	The NACI Executive Secretary provided an update on the NACI forward workplan and recent updates based on consultation with provinces and territories. The NACI Secretariat also presented an update on the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) integration in the NACI process.

March 2023

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) March 7, 2023
Agenda item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest.
Moderna COVID-19 bivalent BA.1 and BA.4/5 bivalent booster doses in children and adolescents 6-17 years of age For Discussion/Decision	The NACI Secretariat provided a summary of evidence on immunogenicity, efficacy, effectiveness and safety for the Moderna COVID-19 BA.1 and BA.4/5 bivalent booster doses in children/adolescents 6-17 years of age. Following the presentation, the COVID-19 Working Group Chair provided an overview of Working Group discussions on the topic. The committee discussed the evidence and potential integration of the Moderna COVID-19 bivalent booster vaccines for those 6 to 17 years of age within existing NACI COVID vaccine guidance, and the committee voted on recommendations. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee and will circulate to NACI members.

February 2023

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) February 6-7, 2023
Agenda item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest.
Health Canada Regulatory Update For Information	Health Canada provided updates for COVID-19 vaccines.
COVID bivalent vaccine as primary series For Information	The NACI Secretariat provided an overview of new evidence and considerations on the potential off-label use of bivalent Omicron-containing mRNA COVID-19 vaccines in a primary series. Following the presentation of evidence, the COVID-19 Working Group Chair provided details of the ongoing Working Group discussions on the topic. The committee discussed evidence and next steps.
COVID high-risk booster guidance update For Discussion/Decision	The NACI Secretariat provided a review of the guidance from other jurisdictions, a summary of evidence to date regarding the epidemiology of SARS-CoV-2, the duration of vaccine protection, hybrid immunity, and EEFA considerations. Following the presentation, the committee discussed the need for an additional booster dose for populations at highest risk of severe COVID-19 disease. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee and will re-circulate to NACI for further discussion and approval.
Advisory Committee on Causality Assessment (ACCA) Thrombosis with thrombocytopenia syndrome (TTS) Briefing For Information	The Executive Secretary of the Advisory Committee on Causality Assessment (ACCA) at the Public Health Agency of Canada provided an introduction to the ACCA and shared ACCA findings for Thrombosis with Thrombocytopenia Syndrome (TTS) causality assessments.
Secretariat Updates and Workplan Overview For Information	The NACI Executive Secretary provided an update on the NACI forward workplan.

January 2023

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) January 23, 2023
Agenda item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and the Vice-President of the Vaccine Roll-out Task Force at PHAC expressed appreciation for NACI's work over the course of this pandemic response. PHAC looks forward to the advice NACI will continue to provide. The NACI Chair and invited any new declarations of interest.
Health Canada Regulatory Update For Information	Health Canada provided updates for COVID-19 vaccines.
COVID Bivalent Vaccine as Primary Series For Information/Discussion	The NACI Secretariat provided an overview of the evidence and considerations on the potential off-label use of bivalent Omicron-containing mRNA COVID-19 vaccines in a primary series. Following the presentation of evidence, the COVID-19 Working Group Chair provided details of the ongoing Working Group discussions on the topic. The committee discussed evidence and preliminary ethical considerations.
Update on NACI continued guidance on COVID-19 vaccine booster doses For Information	The NACI Executive Secretary provided an update to the committee on the Provincial/Territorial reception to NACI's continued guidance on COVID-19 booster published on January 20, 2023. The committee discussed the possibility of further updates to help with program planning in coming months.

December 2022

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) December 13, 2022
Agenda item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest.
NACI Interim Guidance on COVID-19 Booster Program Planning For Discussion/Decision	The NACI Secretariat provided an overview of the evidence and considerations to help inform discussions and decision by NACI on COVID-19 booster program planning for the upcoming year. The presenter provided a review of the decision-making framework for booster doses, current booster recommendations, and a summary of evidence to date regarding the epidemiology of SARS-CoV-2 and duration of vaccine protection. Following the presentation of evidence, the COVID-19 Working Group Chair presented the proposed recommendations from the Working Group. The committee discussed potential simplification of booster recommendations, and the need for close monitoring to enable future booster updates. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee, and will re-circulate to NACI for further discussion and approval.
NACI Guidelines for the Economic Evaluation of Vaccination Programs in Canada For Information	The Economic Guidelines Task Group Chair provided an overview of the first edition of the NACI Guidelines for the Economic Evaluation of Vaccination Programs in Canada. This included key feedback received from stakeholders following a public consultation conducted on the guidelines in Spring 2022. The Guidelines will be provided to the committee in the new year for final approval.
Secretariat Updates For Information	The NACI Executive Secretary provided an update on upcoming committee activities for the committee in 2023, including planning for more extensive integration of GRADE (Grading of Recommendations, Assessment, Development and Evaluations) in several Working Groups that will be launching in 2023.

November 2022

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) November 15, 2022
Agenda item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest.
Health Canada Regulatory Update For Information	Health Canada provided updates for COVID-19 vaccines.
NACI guidance on the use of the Pfizer-BioNTech BA.4/5 bivalent booster doses in children 5-11 years of age For Discussion/Decision	The NACI Secretariat provided an overview of the evidence and considerations to help inform discussions and decision by NACI on updated pediatric guidance in the context of a Pfizer-BioNTech Comirnaty BA.4/5 bivalent booster dose in children 5-11 years of age. Following the presentation of evidence, the COVID-19 Working Group Chair presented the proposed recommendations from the Working Group. The committee discussed and voted on recommendations. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee, and will re-circulate to NACI for further discussion and approval.
Concurrent administration among children 5 years of age and under For Discussion/Decision	The NACI Secretariat provided an overview of the evidence on concurrent administration of Moderna Spikevax (25 mcg) or Pfizer-BioNTech Comirnaty (3 mcg) with non-COVID-19 vaccines among children 6 months to 4 or 5 years of age. Following the presentation, the committee discussed and voted on recommendations. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee, and will re-circulate to NACI for further discussion and approval.

October 2022

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) October 3-4, 2022
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest.
Health Canada Regulatory Update For Information	Health Canada provided updates for COVID-19 vaccines.
Statement on Seasonal Influenza Vaccine for 2023-2024 For Discussion/Decision	The NACI Secretariat provided an overview of structure and content changes to the 2023-2024 Seasonal Influenza Statement proposed by the NACI Influenza Working Group. A summary of the supporting clinical evidence for expanded pediatric indications for two seasonal influenza vaccines (Flucelvax Quad and Influvac Tetra) and updated recommendations on their use were presented. Following the presentation, the committee discussed and voted on recommendations. The NACI Secretariat will amend the Seasonal statement to reflect decisions by the committee, and will circulate to NACI for further discussion and approval. An update on the NACI Influenza Working Group's other ongoing and upcoming projects and activities was also provided.
Pneumococcal conjugate vaccines for Pediatric Populations For Discussion/Decision	The NACI Secretariat provided an overview of the evidence and considerations reviewed by the Pneumococcal Working Group (PWG) on the use of the recently authorised 15-valent pneumococcal conjugate vaccine in pediatric populations and its interchangeability with the 13-valent pneumococcal conjugate vaccine currently used in pediatric programs. The NACI Pneumococcal Working Group Chair presented an overview of the Working Group deliberations and the proposed interim recommendation on the use of the 15-valent pneumococcal conjugate vaccine in pediatric populations. Following the presentation, the committee discussed and voted on recommendations. The NACI Secretariat will prepare a rapid response statement to reflect decisions by the committee, and will circulate to NACI for review and approval.
Updating guidance on the use of Influenza vaccine in pregnancy For Information/Discussion	The NACI Secretariat provided an overview of the Influenza Working Group's proposed approach, key considerations and discussions to date for the review of safety and effectiveness of influenza vaccine in pregnancy. Following the presentation, the Committee provided feedback on the approach proposed by the Influenza Working Group.
National Immunization Technical Advisory Groups (NITAG) Collaboration For Information	The NACI Executive Secretary provided a verbal update to the committee on an upcoming partnership program the Secretariat will be involved in with other NITAGs.
NACI 2022-2024 Workplan update For Information	The NACI Executive Secretary provided a status update to the committee on the NACI 2022-2024 workplan, which is posted online. An overview of ongoing and upcoming Working Group activities was also provided.
NACI Liaison Representative and Ex-Officios updates on key items For Information	Some NACI liaison and ex officio representatives provided written updates on key emerging and ongoing issues of interest to NACI, from the perspective of their respective organizations.

September 2022

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) September 27, 2022
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest.
Health Canada Regulatory Update For Information	Health Canada provided updates for COVID-19 vaccines.
COVID-19 Booster Program Vaccine Acceptance, Hesitancy and Refusal For Information	A NACI Member provided an overview of their research findings on COVID vaccine confidence and provided perspectives for the next phase of the COVID booster program.
Framing updated COVID-19 booster guidance in context of Pfizer-BioNTech Comirnaty BA.4/5 Bivalent vaccine For Discussion/Decision	The NACI Secretariat provided a summary of the evidence for the Pfizer-BioNTech Comirnaty BA.4/5 COVID-19 bivalent vaccine, as well as current NACI recommendation on the use of bivalent Omicron-containing mRNA COVID-19 vaccine. The NACI COVID-19 Working Group Chair provided an overview of the Working Group deliberations and proposed recommendations for decision by the committee. Following the presentation, the committee discussed and voted on the recommendation. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee, and will re-circulate to NACI for further discussion and approval.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) September 12-13, 2022
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest.
NACI Liaison Representative and Ex-Officios updates on key items For Information	Some NACI liaison and ex officio representatives provided written updates on key emerging and ongoing issues of interest to NACI, from the perspective of their respective organizations.
Pneumococcal PCV15 and PCV20 for Adults For Discussion/Decision	The NACI Secretariat provided a summary of discussions by the committee at a previous meeting on two pneumococcal conjugate vaccines recently authorized for use in Canada in adults 18 years of age or older. The NACI Pneumococcal Working Group Chair presented an overview of the Working Group deliberations and the proposed recommendations on the use of 15- or 20-valent pneumococcal conjugate vaccines in scenarios including or compared to a 23-valent pneumococcal polysaccharide vaccine in adults. Following the presentation, the committee discussed and voted on recommendations. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee.
Updating NACI guidance on pediatric COVID-19 vaccines in the context of Pfizer-BioNTech Comirnaty for children 6 months to 4 years of age For Discussion/Decision	The NACI Secretariat provided an overview of the policy questions, international regulatory updates, evidence and other considerations on the use of the Pfizer-BioNTech Comirnaty COVID-19 vaccine for children 6 months to 4 years of age. The NACI COVID-19 Working Group Chair provided an overview of the Working Group deliberations and the proposed recommendations for decision by the committee. Following the presentation, the committee discussed and voted on several recommendations. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee, and will re-circulate to NACI for further discussion and approval.
Health Canada Regulatory Update For Information	Health Canada provided updates for COVID-19 vaccines.
Next generation COVID-19 vaccines (Pfizer Bivalent COVID-19 Vaccine) For Discussion/Decision	The NACI Secretariat provided a summary of the evidence as well as current NACI recommendations on the use of bivalent Omicron-containing mRNA COVID-19 vaccines. The NACI COVID-19 Working Group Chair provided an overview of the Working Group deliberations and proposed recommendations for decision by the committee. Following the presentation, the committee discussed and voted on the recommendation. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee, and will re-circulate to NACI for further discussion and approval.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) September 6, 2022
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest.
Update to NACI Imvamune guidance and Monkeypox vaccination scenario modeling For Discussion/Decision	The NACI Secretariat provided an overview of the data on the current status of the monkeypox outbreak in Canada and globally, along with additional evidence included in published scientific literature and from the manufacturer, regarding the safety, immunogenicity and protection offered by Imvamune. Modelling information on the impact of dose sparing strategies when vaccine supply is limited was also reviewed. The NACI High Consequence Infectious Disease Working Group Chair presented the proposed recommendations from the Working Group on the use of Imvamune in the context of Monkeypox outbreaks in Canada. The committee discussed and voted on the recommendations. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee, and will re-circulate to NACI for further discussion and approval.

August 2022

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) August 18, 2022
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Health Canada Regulatory Update For Information	Health Canada provided updates for COVID-19 vaccines.
Next generation COVID-19 vaccines (Moderna Spikevax Bivalent COVID-19 Vaccine) For Discussion/Decision	The NACI Secretariat provided an overview of the available evidence to date on the Moderna Spikevax Bivalent vaccine and the post-market safety of booster doses of mRNA vaccines. Following the presentation of evidence, the COVID-19 Working Group Chair presented the proposed recommendations from the Working Group on the use of this bivalent Omicron-containing mRNA COVID-19 vaccine. Following the presentation, the committee discussed and voted on recommendations. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee, and will re-circulate to NACI for further discussion and approval.

July 2022

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) July 5, 2022
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Health Canada Regulatory Update For Information	Health Canada provided updates for COVID-19 vaccines.
NACI Liaison Representative and Ex-Officios updates on key items For Information	Some NACI liaison and ex officio representatives provided written updates on key emerging and ongoing issues of interest to NACI, from the perspective of their respective organizations.
COVID-19 Series Completion for Pediatric Populations with History of Myocarditis For Discussion/Decision	The NACI Secretariat provided an overview of the evidence for the receipt of further doses of COVID-19 vaccine among individuals aged 5-11 years with a history of myocarditis/pericarditis following a previous dose of mRNA COVID-19 vaccine. Following the presentation, the committee discussed and voted on the recommendation, to be updated in the Canadian Immunization Guide (CIG) COVID-19 vaccine chapter.
NACI COVID-19 Pregnancy Recommendations For Discussion/Decision	The NACI Secretariat provided an overview of context, policy questions, evidence and considerations for proposed recommendations from the NACI COVID-19 Working Group on the use of COVID-19 vaccines in pregnant and breastfeeding individuals. Following the presentation, the committee discussed and voted on recommendations. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee, and will re-circulate to NACI for further discussion and approval.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) July 4, 2022
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Pneumococcal conjugate vaccines (PCV15 and PCV20) Overview of Evidence For Information	The NACI Pneumococcal Working Group Chair provided remarks on the Working Group deliberations for the recommended use of the two pneumococcal conjugate vaccines (PCV) that have been recently authorized for use in Canada in adults 18 years of age or older. The NACI Secretariat provided an overview of a cost-utility analysis comparing the use of 15- or 20-valent pneumococcal conjugate vaccines in scenarios including or compared to a 23-valent pneumococcal polysaccharide vaccine in adults, and also provided an overview of the evidence, which included a summaries of the burden of pneumococcal disease, immunogenicity and safety, and key ethics, equity, feasibility and acceptability (EEFA) factors.
Pneumococcal PCV15 and PCV20 Recommendations For Discussion/Decision	Following the presentation of evidence, the committee discussed and voted on several elements of forthcoming guidance for the use of the new PCV vaccines in adults. The NACI Secretariat and Pneumococcal Working Group will update a draft statement to reflect decisions by the committee, and will bring to NACI for further discussion and approval at a future meeting where several outstanding decisions will be made.

June 2022

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) June 21, 2022
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Health Canada Regulatory Update For Information	Health Canada provided updates for COVID-19 vaccines.
NACI Liaison Representative and Ex-Officios updates on key items For Information	Some NACI liaison and ex officio representatives provided written updates on key emerging and ongoing issues of interest to NACI, from the perspective of their respective organizations.
Updated guidance on the use of pediatric COVID-19 mRNA vaccines: Moderna Spikevax for children 6 months to 5 years of age For Discussion/Decision	The NACI Secretariat provided the committee with a recap of the discussion at the June 7, 2022, meeting on pediatric COVID-19 vaccines in the context of Moderna Spikevax for children 6 months to 5 years of age. Following the presentation, the committee discussed and voted on several elements of guidance for pediatric COVID-19 vaccines for children 6 months to 5 years of age, in the event that a regulatory decision is issued in Canada.
Updated guidance on the use of pediatric COVID-19 mRNA vaccines: COVID-19 booster for children 5 to 11 years of age For Discussion/Decision	The NACI Secretariat provided an overview of the evidence and considerations to help inform discussions and decision by NACI on updated pediatric guidance in the context of Pfizer-BioNTech's first booster dose for children aged 5 to 11 years, in the event that a regulatory decision is issued in Canada. Following the presentation, the committee discussed and voted on several elements of guidance for pediatric COVID-19 vaccine boosters for children 5 to 11 years of age.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) June 7, 2022
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Health Canada Regulatory Update For Information	Health Canada provided updates for COVID-19 vaccines.
Vaccine Safety Working Group Update on General Activities For Information	The NACI Vaccine Safety Working Group Chair provided an update on working group activities, discussions and planning
NACI Liaison Representative and Ex-Officios updates on key items For Information	Some NACI liaison and ex officio representatives provided updates on key emerging and ongoing issues of interest to NACI, from the perspective of their respective organizations.
Navigating web products and finding CIG summaries For Information	The NACI Secretariat provided the committee with an overview of the recent update to the Canadian Immunization Guide (CIG) COVID-19 chapter. This updated included a running list of references to inform readers on the evidence informed updates made to the chapter when there are no stand-alone NACI Statements to consult for evidence references.
COVID-19 Fall 2022 Booster program planning For Discussion/Decision	The NACI Secretariat provided the committee with a recap presentation on the planning considerations for a Fall 2022 COVID-19 booster program which was first discussed at the May 24, 2022, meeting. Following the presentation, the committee discussed and voted on the proposed recommendations for a Fall 2022 COVID-19 booster program.
Updated guidance on the use of pediatric COVID-19 mRNA vaccines: Moderna Spikevax for children 6 months to 5 years of age For Discussion/Decision	The NACI Secretariat provided an overview of the evidence and considerations to help inform discussions and decisions by NACI on updated guidance of pediatric COVID-19 vaccines in the context of Moderna Spikevax for children 6 months to 5 years of age, in the event that a regulatory decision is issued in Canada. Following the presentation, the committee discussed and voted on several elements of guidance for pediatric COVID-19 vaccines for children 6 months to 5 years of age. NACI will conclude deliberations and voting on June 21.
Update on Monkeypox For Information	The NACI Secretariat provided the committee with an update on upcoming NACI interim guidance on the use of Imvamune in the context of Monkeypox outbreaks in Canada and discussed the longer-term workplanning for NACI and the High-Consequences Infectious Diseases (HCID) Working Group in relation to Monkeypox.

May 2022

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) May 24, 2022
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Health Canada Regulatory Update For Information	Health Canada provided updates for COVID-19 vaccines.
NACI Liaison Representative and Ex-Officios updates on key items For Information	Some NACI liaison and ex officio representatives provided updates on key emerging and ongoing issues of interest to NACI, from the perspective of their respective organizations.
Interval between prophylactic use of Evusheld and active vaccination against SARS-CoV-2 For Discussion/Decision	The NACI Secretariat provided an overview of the scope and policy questions, the Canadian and International guidance on recommended intervals for Evusheld before/after COVID-19 vaccination and the summary of the evidence to inform intervals between Evusheld administration and COVID-19 vaccination. Following the presentation, the committee discussed and voted on updated recommendations on the intervals between prophylactic use of Evuhseld and active vaccination against SARS-CoV-2, which will appear in the Canadian Immunization Guide (CIG) COVID-19 chapter.
COVID-19 Fall 2022 Booster program planning For Information/Discussion	The NACI Secretariat provided an overview of the planning considerations for a Fall 2022 COVID-19 booster program. Canadian jurisdictions have started planning the fall immunization strategy and have requested NACI's opinion on key populations, intervals, and timing. Following the presentation, the committee discussed evidence and considerations. The proposed recommendations will be discussed by the committee at a future meeting.
Update on Monkeypox For Information	The NACI Secretariat provided the committee with an update on upcoming High-Consequences Infectious Diseases (HCID) Working Group activities and next steps on vaccine guidance in the context of Monkeypox outbreaks in Canada.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) May 10, 2022
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Health Canada Regulatory Update For Information	Health Canada provided updates for COVID-19 vaccines.
Administration of COVID-19 vaccines with non-COVID vaccines For Discussion/Decision	The NACI Secretariat provided an update on administration of pediatric mRNA COVID-19 vaccines with other vaccines. Items covered by this presentation included the context and rationale for revisiting NACI guidance, an overview of the impact of the COVID-19 pandemic on routine pediatric vaccination in Canada, and the NACI Vaccine Safety Working Group's assessment summary and proposed updated recommendation being presented for decision by NACI. Following the presentation, the committee discussed and voted on updated recommendations on the administration of pediatric mRNA COVID-19 vaccines with other vaccines.
TST/IGRA recommendations in CIG COVID-19 chapter For Discussion/Decision	The NACI Secretariat provided an update on the evidence for recommendations in the Canadian Immunization Guide on Tuberculin skin tests (TST) and Interferon-Gamma Release Assays (IGRA) before or after COVID-19 vaccines. This presentation included the context and rationale for updating the guidance, a summary of international and domestic recommendations on TST and IGRAs before or after COVID-19 vaccines, and results from the literature review conducted on the subject. The proposed updated recommendations were presented to NACI. Following the presentation from the NACI Secretariat, the committee determined that further engagement with Tuberculosis experts was needed to inform final decisions.
Pneumococcal adult PCV15 and PCV20 evidence and context For Information/Discussion	The NACI Secretariat provided an overview of policy questions and key evidence for NACI on the adult pneumococcal vaccine program. The evidence-to-decision framework, full economic analysis and the proposed recommendations will be presented and discussed by the committee at a future meeting.

April 2022

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) April 26, 2022
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Health Canada Regulatory Update For Information	Health Canada provided updates for COVID-19 vaccines.
Vaccine Safety Working Group Update on General Activities For Information	The NACI Vaccine Safety Working Group Chair provided an update on working group activities, discussions and planning.
NACI Liaison Representative and Ex-Officios Updates on Key Items For Information	The NACI liaison and ex officio representatives provided updates on key emerging and ongoing issues of interest to NACI, from the perspective of their respective organizations.
NACI 2022-2024 Workplan For Information/Discussion	The NACI Secretariat provided an overview of the results of the prioritization consultation conducted with NACI members and Provincial and Territorial stakeholders on proposed 2022-2024 NACI workplan for non-COVID-19 activities. The objective of this consultation was to establish a prioritised list of topics that NACI can use once capacity is freed up from COVID-19 activities over time. The committee discussed priority level of potential workplan items.
Immunocompromised List: Proposed Modifications For Discussion/Decision	The NACI Secretariat provided an overview of a proposed update to conditions listed in the suggested definition of "moderately to severely immunocompromised" within the Canadian Immunization Guide (CIG) COVID-19 chapter. This presentation included a presentation of supporting evidence for the update and a summary of the feedback received from stakeholders on this list. Following the presentation from the NACI Secretariat, the committee discussed and voted on the proposed updates to be made to the list of conditions in the definition of moderately to severely immunocompromised.
Patients with a history of VITT/TTS: Proposed Recommendations For Discussion/Decision	The NACI Secretariat provided an overview of the available evidence on Thrombosis with thrombocytopenia syndrome (TTS)/Vaccine-induced immune thrombotic thrombocytopenia (VITT), which triggered a review by the NACI Vaccine Safety Working Group. Proposed recommendations from the NACI Vaccine Safety Working Group on COVID-19 vaccination among individuals with a history of TTS/VITT after a previous dose of viral vector COVID-19 vaccine were reviewed, discussed and voted on by the committee.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) April 12, 2022
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Health Canada Regulatory Update For Information	Health Canada provided updates for COVID-19 vaccines.
Vaccine Safety Working Group Update on General Activities For Information	The NACI Vaccine Safety Working Group Chair provided an update on working group activities, discussions and planning.
NACI Liaison Representative and Ex-Officios Updates on Key Items For Information	The NACI liaison and ex officio representatives provided updates on key emerging and ongoing issues of interest to NACI, from the perspective of their respective organizations.
NACI Equity matrix for key populations For Information	PHAC presented an overview of NACI's COVID-19 prioritization framework, including updated equity factors and considerations of future prioritization for booster programs.
List of key populations for a second booster For Discussion	Following the presentation, the committee discussed the original list of key populations for COVID-19 vaccination, and whether it is necessary to revisit the list given current knowledge and in the context of subsequent booster dose recommendations in the event that there is constrained supply of new booster products. The committee will be revisiting this topic at a future meeting.

March 2022

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) March 22, 2022
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Health Canada Regulatory Update For Information	Health Canada provided updates for COVID-19 vaccines.
NACI Liaison Representative and Ex-Officios Updates on Key Items For Information	The NACI liaison and ex officio representatives provided updates on key emerging and ongoing issues of interest to NACI, from the perspective of their respective organizations.
Hematopoietic stem-cell transplantation (HSCT) and COVID-19 revaccination recommendation For Discussion/Decision	The Canadian Immunization Guide (CIG) Part 3 Working Group Chair provided background on guidance on re-vaccination after HSCT in the CIG, scans and evidence reviews, and the proposed recommendations for timing of COVID-19 vaccination post-HSCT and CAR-T (chimeric antigen receptor) cell therapy. Following the presentation, the committee discussed evidence and voted on recommendations. The NACI Secretariat will update proposed recommendations within the CIG to reflect decisions by the committee.
NACI COVID-19 vaccine booster recommendations For Discussion/Decision	The NACI Secretariat provided an overview of the policy questions, summary of evidence and other considerations (such as Ethics, Equity, Feasibility and Acceptability considerations) for the discussion on NACI booster recommendations. Following the presentation from NACI Secretariat, the committee discussed the recommendations on booster doses of mRNA COVID-19 vaccines for adults who are 18-49 years of age and for adolescents who are 12-17 years of age. The committee also concluded discussion of recommendations related to a second booster dose for long-term care (LTC) residents and older adults, which began at the March 1 meeting. The committee voted on recommendations. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee, and will re-circulate to NACI for further discussion and approval.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) March 1, 2022
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Health Canada Regulatory Update For Information	Health Canada provided updates for COVID-19 vaccines.
Vaccine Safety Working Group Update on General Activities For Information	The NACI Vaccine Safety Working Group Chair provided an update on working group activities, discussions and planning.
NACI Liaison Representative and Ex-Officios Updates on Key Items For Information	The NACI liaison and ex officio representatives provided updates on key emerging and ongoing issues of interest to NACI, from the perspective of their respective organizations.
Presentation: Second booster for residents of long term care (LTC) evidence and considerations For Information	The NACI Secretariat provided a review of the available evidence relating to a second booster dose for older adults including those residing in long-term care (LTC) or congregate living settings. This presentation included review of evidence on the burden of disease, vaccine coverage, immunogenicity, efficacy, effectiveness, safety. EEFA (Ethics, Equity, Feasibility, Acceptability) considerations were also presented.
Recommendations on a second booster for residents of long-term care (LTC) For Discussion/Decision	Following the presentation, the committee discussed the available evidence and considerations relating to a second booster dose for long-term care (LTC) residents and older adults, and preparedness for emergence of new variants of concern or resurgence of existing variants. The committee voted on recommendations and the NACI Secretariat will update proposed recommendations to reflect decisions by the committee, and will re-circulate to NACI for further discussion and approval.

February 2022

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) February 15, 2022
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Health Canada Regulatory Update For Information	Health Canada provided updates for COVID-19 vaccines.
Vaccine Safety Working Group Update on General Activities For Information	The NACI Vaccine Safety Working Group Chair provided an update on working group activities, discussions and planning.
NACI Liaison Representative and Ex-Officios Updates on Key Items For Information	The NACI liaison and ex officio representatives provided updates on key emerging and ongoing issues of interest to NACI, from the perspective of their respective organizations.
Medicago COVID-19 vaccine recommendations For Discussion/Decision	The NACI Secretariat provided an evidence update on the Medicago COVID-19 vaccine. Following the presentation, the committee discussed the evidence and considerations and voted on several recommendations for the use of the Medicago COVID-19 vaccine, in the event that a regulatory decision is issued in Canada. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee, and will re-circulate to NACI for further discussion; and further approvals at a future meeting.
Moderna 6-11 years pediatric COVID-19 vaccine For Information	The presenter from NACI Secretariat provided a recap of the evidence summary on the Moderna COVID-19 vaccine for those 6 to 11 years age previously presented to NACI on February 1, 2022, and included an update on new evidence.
Moderna 6-11 years pediatric COVID-19 vaccine recommendations For Discussion/Decision	Following the presentation, the committee discussed the evidence and voted on several recommendations for the use of the Moderna COVID-19 vaccine for those 6 to 11 years age, in the event that a regulatory decision is issued in Canada. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee, and will re-circulate to NACI for further review and approvals.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) February 1, 2022
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Health Canada Regulatory Update For Information	Health Canada provided updates for COVID-19 vaccines.
Vaccine Safety Working Group Update on General Activities For Information	The NACI Vaccine Safety Working Group Chair provided an update on working group activities, discussions and planning.
NACI Liaison Representative and Ex-Officios Updates on Key Items For Information	The NACI liaison and ex officio representatives provided verbal updates on key emerging and ongoing issues of interest to NACI, from the perspective of their respective organizations.
Final NACI Economic Process For Approval	The NACI Secretariat and the Economics Task Group Chair presented the final NACI Economic Process outlining when and how NACI incorporates economic evidence for vaccine recommendations. This process has been in development for several years, and following several consultations and reviews, the final process was approved by NACI at the meeting.
Presentation: Moderna 6-11 years pediatric COVID-19 vaccine evidence For Information	The NACI Secretariat provided an evidence update on Moderna Spikevax pediatric vaccine (50 mcg; for children 6-11 years of age). This update included burden of disease evidence, clinical evidence on immunogenicity, efficacy and safety, and the real world safety surveillance data for mRNA COVID-19 vaccines among children and older age groups. This issue will be brought back to NACI for decision at a future meeting.
Safety update on Novavax COVID-19 vaccine For Discussion/Decision	The NACI Secretariat provided a safety update related to some preliminary events of myocarditis following vaccination with Novavax COVID-19 vaccine. The committee discussed the evidence and agreed to continue to review information as it becomes available and will take appropriate action as needed.
Recommendations on the use of Medicago COVID-19 vaccine For Discussion/Decision	The presenter from NACI Secretariat provided a recap of the evidence summary on the Medicago COVID-19 vaccine previously presented to NACI on January 25, 2022, and included an update on new evidence since. Following the presentation, the committee discussed the evidence and considerations and voted on several recommendations for the use of the Medicago COVID-19 vaccine, in the event that a regulatory decision is issued in Canada. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee, and will re-circulate to NACI for further discussion via email and further approvals at a future meeting.

January 2022

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) January 25, 2022
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Presentation: Medicago COVID-19 Vaccine Evidence For Information	The NACI Secretariat provided a presentation on the evidence for Medicago CoVLP COVID-19 vaccine. This overview included efficacy, immunogenicity and safety data of the vaccine in adults.
Presentation: Framing Medicago and Novavax COVID-19 vaccine recommendations For Information	The NACI Secretariat provided a recap of the evidence summary for Novavax provided to NACI at the December 14, 2021, meeting and an update on the new evidence since then. Following this recap and update, the Secretariat put both the Novavax and Medicago COVID-19 vaccines in context with other COVID-19 vaccines authorized in Canada to help frame upcoming NACI recommendations.
Recommendations on the use of Novavax COVID-19 vaccines For Discussion and Decision	Following the presentation, the committee discussed the evidence and considerations and voted on its advice for the use of the Novavax COVID-19 vaccine, in the event that a regulatory decision is issued in Canada. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee, and will re-circulate to NACI for approval following the meeting.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) January 18, 2022
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Health Canada Regulatory Update For Information	Health Canada provided updates for COVID-19 vaccines.
Vaccine Safety Working Group Update on General Activities For Information	The NACI Vaccine Safety Working Group Chair provided an update on working group activities, discussions and planning.
NACI Liaison Representative and Ex-Officios Updates on Key Items For Information	The NACI liaison and ex officio representatives provided verbal updates on key emerging and ongoing issues of interest to NACI, from the perspective of their respective organizations.
Presentation: Boosters for adolescents 12-17 years of age at high risk of severe disease For Information	The NACI Secretariat provided a presentation on options for booster doses of the COVID-19 vaccine in adolescents 12-17 years of age who are at high risk of severe outcomes from COVID-19. The presentation included a scan of domestic and international recommendations, a review of current COVID-19 vaccination program goals, and the current Canadian Immunization Guide (CIG) list of conditions at high risk of severe outcomes.
Boosters for adolescents 12-17 years of age at high risk of severe disease For Discussion/Decision	Following the presentation, the committee discussed the list of medical co-morbidities and the social determinants of health that put adolescents 12-17 years of age at higher risk for severe COVID-19 outcomes. The committee voted on off-label recommendations for the use of COVID-19 boosters for adolescents 12-17 years of age who may be at higher risk of severe outcomes from COVID-19 infection, including those who experience biological and/or social risk factors that may intersect, and may experience systemic barriers to accessing health care.The NACI Secretariat will update the recommendations to reflect decisions by the committee, and will re-circulate to NACI for approval following the meeting.
Presentation: Interval between previous infection and vaccination For Information	The NACI Secretariat provided a presentation on the topic of previous infection and COVID-19 vaccine timing. A summary was provided on current NACI recommendations, international recommendations and the current evidence.
Interval between previous infection and vaccination For Discussion	Following the presentation, the committee discussed whether there is an interval between infection and vaccination that would be reasonable, based on expert opinion. There was consensus that some longer intervals will be appropriate, in the range of weeks during a primary series or months before a booster dose. Recommendations will be finalised through post meeting communication and statement drafting.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) January 11, 2022
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Health Canada Regulatory Update For Information	Health Canada provided updates for COVID-19 vaccines.
NACI COVID-19 work plan for early 2022 For Information	The NACI Executive Secretary provided the committee with an overview of COVID-19 vaccine policy issues and questions for NACI to review in early 2022.
Presentation: Primary series for 5-11 years of age For Information	The NACI Secretariat provided a presentation on the use of the Pfizer-BioNTech COVID-19 vaccine in children who are 5 to 11 years of age. Items covered by this presentation included new safety evidence from the US and Canada, and key points on Omicron epidemiology and susceptibility to vaccines.
Strength of recommendation for primary series for 5-11 years of age For Discussion/Decision	Following the presentation, the committee discussed the evidence and strength of its recommendation on the use of COVID-19 vaccine in children who are 5 to 11 years of age. In careful consideration of this additional evidence and safety data that has emerged since NACI first issued guidance in November 2021 on the use of the Pfizer-BioNTech COVID-19 vaccines in children 5 to 11 years of age, NACI moved to strengthen their recommendation from discretionary to strong. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee, and will re-circulate to NACI for approval following the meeting.
Presentation: Additional doses for 5-11 years of age who are immunocompromised (IC) For Information	The NACI Secretariat provided a presentation on the potential use of the COVID-19 vaccine in children 5-11 years of age who are moderately to severely immunocompromised. The presenter provided an overview of national and international scans on recommendations for additional doses in individuals who are immunocompromised as well as other ethics, equity, feasibility, acceptability (EEFA) considerations and key data in adults who are moderately to severely immunocompromised.
Recommendation on additional doses for 5-11 years of age who are immunocompromised (IC) For Discussion/Decision	Following the presentation, the committee discussed evidence and considerations for a recommendation on additional COVID-19 doses in children 5 to 11 years of age who are immunocompromised, and agreed that moderately to severely immunocompromised children 5 to 11 years of age should be immunized with a primary series of three doses of the Pfizer-BioNTech COVID-19 vaccine. The NACI Secretariat will update proposed recommendations to reflect decisions by the committee, and will re-circulate to NACI for approval following the meeting.
Presentation: Booster doses for individuals 12-17 years of age For Information	The NACI Secretariat provided a presentation on evidence and considerations for an off-label recommendation for COVID-19 booster doses for individuals 12 to 17 years of age, which included a jurisdictional scan of COVID-19 boosters for adolescents, as well as an overview of EEFA considerations, and a review of the evidence on vaccine effectiveness after primary series (in adolescents) and boosters (in adults) pre-Omicron.
Recommendation on booster doses for individuals 12-17 years of age For Discussion	Following the presentation, the committee discussed evidence and considerations and agreed that a primary series for all adolescents will continue to be strongly recommended. However NACI will continue to monitor the evidence closely and there will be no recommendations for booster doses for the general adolescent population made at this time. The committee will reconvene to discuss recommendations on booster doses for adolescents living with high-risk conditions at the next meeting.

December 2021

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) December 14, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Presentation: Omicron Evidence Update	PHAC provided a review of the immunological principles in relation to current NACI guidance, and an overview of Omicron evidence, specifically what is known and unknown to date.
Discussion: Omicron and vaccine programs	NACI reviewed a summary of available evidence on the epidemiology of the Omicron (B.1.1.529) variant, feasibility of booster programs, immunological principles, and emerging data on vaccine performance. Through discussions, the committee outlined the following updated advice that was immediately communicated to the Council of Chief Medical Officers of Health on December 14. NACI continues to recommend that an interval of ≥6 months should be used between the final dose of a primary series and a booster dose. NACI continues to recommend that an interval of at least 8 weeks should be used between first and second dose in those 5-11 years of age. NACI continues to recommend that a booster dose should be offered to those 50 years of age and older as well as other key populations at high risk as previously recommended. NACI continues to recommend that booster doses may be offered to all those who are 18 to 49 years of age and in light of the Omicron variant in Canada, NACI highlights the following jurisdictional considerations intended to inform the need for booster doses of COVID-19 vaccine in this age range: circulation of the variant of concern; evidence of decreasing protection against infection and symptomatic disease over time following the primary series; and ensuring health system access and capacity. NACI continues to recommend that as programs roll out, booster doses should be prioritised for the groups previously listed, and additionally underscores emphasis for booster doses for all healthcare workers and for those at highest risk of severe illness from COVID-19, including those in older age groups and those with high risk medical conditions. Throughout their discussions, NACI also identified the following themes: It is clear that the Omicron variant of concern is going to have a significant impact on disease transmission in Canada, and also likely on public health and health care capacity. There is still much unknown about the epidemiology of the Omicron variant, and the ability of vaccines to protect against it. Booster doses are likely to offer protection against severe disease, though protection from symptomatic infection is likely to decrease eventually following the booster and increased breakthrough infections are expected over time. Healthcare workers are essential to maintain healthcare capacity and a booster is likely to protect against infection for the short term, reducing need for isolation and absence from work. Longer intervals between vaccine doses allow for more robust strength and breadth of immune responses, which may be important to improve durable protection against variants of concern. Omicron is likely to be a dominant virus in the population for months or more, and it will be important to optimize protection over the long term and not only over holiday periods. Vaccines are only one part of a dynamic public health response, and it is important to maintain recommended public health measures over coming weeks and months while the most robust immune response to the primary series or booster dose can be established using optimal intervals. Manufacturers are currently working on Omicron-specific mRNA boosters, which may become available within 6 months. It is important to consider the potential impact these might have if integrated into the booster landscape. Due to the rapidly escalating transmission of the Omicron variant, it is particularly important to prioritize those with advanced age, healthcare workers and those with high risk medical conditions among the groups that have already been identified by NACI. In addition, ensuring vaccine uptake in vulnerable populations with intersecting risk factors continues to be critical. The risk of severe illness from COVID-19, and the proportion of individuals with at least one underlying medical condition increase with age. The committee will provide further advice as needed.
Presentation: Evidence and considerations for recommendations on the use of Novavax COVID-19 vaccine	PHAC provided a summary of the evidence on the Novavax COVID-19 vaccine, and provided additional considerations on Novavax in relation to the current COVID-19 vaccine context in Canada.
Discussion: Recommendations on the use of Novavax COVID-19 vaccine	Following the presentation, the committee discussed the evidence and will revisit possible recommendations at an upcoming NACI meeting.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) December 7, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Health Canada Regulatory Update For Information	Health Canada provided updates for COVID-19 vaccines.
Vaccine Safety Working Group Update on General Activities For Information	The NACI Vaccine Safety Working Group Chair provided an update on working group activities, discussions and planning.
NACI Liaison Representative and Ex-Officios Updates on Key Items For Information	The NACI liaison and ex officio representatives provided verbal updates on key emerging and ongoing issues of interest to NACI, from the perspective of their respective organizations.
NACI Draft Guidelines for Economic Evaluations of Vaccination Programs in Canada (approval to proceed to public consultation) For Approval	The Chair of the NACI Economic Guidelines Task Group provided an overview of draft guidelines for economic evaluations of vaccines in Canada, developed by the Task Group over the past two years. The guidelines were presented to NACI for approval to proceed to a public consultation, which will include a survey and webinar. The committee members provided their approval to move forward with the consultation, which is expected to launch in the winter of 2022.
Presentation: Revaccination after myocarditis/pericarditis For Information	The NACI Secretariat provided a summary of the evidence on revaccination after reported myocarditis/pericarditis, which included an outline of the latest safety data from the United States and recommendations from the United Kingdom (UK). Proposed recommendations from the NACI Vaccine Safety Working Group on the issue were presented for discussion and consideration.
Revaccination after myocarditis/pericarditis For Discussion	Following the presentation, the committee discussed the evidence and recommendation for individuals with a history of myocarditis and/or pericarditis after a previous dose of mRNA COVID-19 vaccines. The NACI Secretariat will update proposed recommendations to reflect discussion by the committee and expert cardiologists, and will re-circulate to NACI for review following the meeting.

November 2021

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) November 30, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Health Canada Regulatory Update For Information	Health Canada provided updates for COVID-19 vaccines.
Booster Dose Guidance: Context/Updates, Evidence, Proposed approach For Information	The NACI Secretariat provided an overview of the context and evidence for COVID-19 booster guidance. The presentation included an overview of the objectives to guide booster dose recommendations, evidence of efficacy/effectiveness, immunogenicity, safety, vaccine protection of the primary series and vaccine protection against transmission. There was also acknowledgement of limited emerging evidence for the Omicron B.1.1.529 variant of concern.
Discussion: Booster Dose Guidance	The Committee reviewed and discussed the evidence and considerations for booster doses of COVID-19 vaccines in key populations, including strength of recommendations. Key populations include people aged 50 years and older, adults living in long-term care homes for seniors or other congregate living settings that provide care for seniors, recipients of a viral vector vaccine series, adults in or from First Nations, Inuit and Métis communities, all frontline healthcare workers having direct in-person contact with patients and adults 18 to 49 years of age. The committee voted on its updated booster recommendations and consensus was reached.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) November 23, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Health Canada Regulatory Update For Information	Health Canada provided updates for COVID-19 vaccines.
Vaccine Safety Working Group Update on General Activities For Information	The NACI Vaccine Safety Working Group Chair provided an update on working group activities, discussions and planning. This includes plans to provide further advice on series completion for those who had myocarditis following a first dose.
NACI Liaison Representative and Ex-Officios Updates on Key Items For Information	The NACI liaison and ex officio representatives provided verbal updates on key emerging and ongoing issues of interest to NACI, from the perspective of their respective organizations.
Presentation: Canadian National Vaccine Safety (CANVAS) Network Data on Previous Infection For Information	The presenter from CANVAS Network provided an overview of active safety surveillance for COVID-19 vaccine in individuals with previous COVID infection.
Presentation: Previous Infection for Primary Series and Booster For Information	The NACI Secretariat provided an overview of the evidence, considerations and policy questions in relation to COVID-19 vaccine recommendations for individuals who have had previously PCR-confirmed SARS-CoV-2 infection.
Discussion: Previous Infection Recommendation for Primary Series and Booster For Discussion	The Committee reviewed the topic of recommendations for persons with previous infection to consider new evidence since the topic was last reviewed in June 2021. NACI reaffirmed their position, and will seek to clarify the wording in upcoming publications of the Canadian Immunization Guide to facilitate knowledge translation and clinical practice.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) November 16, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Proposed updates related to myocardtitis/pericarditis following COVID-19 vaccination For Information	The NACI Secretariat provided an evidence update on the incidence of myocarditis/pericarditis following mRNA COVID-19 vaccination and presented an overview of the decision points for the committee to deliberate on.
NACI recommendations on myocarditis/pericarditis following COVID-19 vaccination For Discussion / Decision	Following the presentation, the committee discussed the evidence of myocarditis/pericarditis following mRNA COVID-19 vaccination and voted on recommendations proposed by the Vaccine Safety Working Group on the use of mRNA COVID-19 vaccines in specific populations. The NACI Secretariat will update proposed recommendations to reflect discussion and decisions by the committee, and will re-circulate to NACI for final review and approval following the meeting.
Moderna Dose For Discussion / Decision	The NACI Secretariat provided an overview of the current NACI booster dose recommendations and considerations relating to vaccine authorisations and Moderna COVID-19 booster dosage according to age group. Following the presentation, the committee discussed and reaffirmed their position on the recommended booster dosage of 100mcg for adults 70 years of age and older, and adults residing in LTC facilities.
Proposed guidance on boosters for Immunocompromised populations For Information	The NACI Secretariat provided an overview of the considerations for booster dose recommendations for moderately to severely immunocompromised individuals who have completed a 3-dose primary series of COVID-19 vaccines and who are currently recommended for booster dose.
NACI recommendation on Boosters for IC populations For Discussion	Following the presentation, the committee discussed the recommendation (and strength of the recommendation) for booster doses for moderately to severely immunocompromised adults who have completed a 3 dose primary series. The topic will be revisited in context of future booster updates.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) November 9, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Health Canada Regulatory Update For Information	Health Canada provided both pre- and post-market updates for COVID-19 vaccines.
Vaccine Safety Working Group Update on General Activities For Information	The NACI Vaccine Safety Working Group Chair provided an update on working group activities, discussions and planning.
NACI Liaison Representative and Ex-Officios Updates on Key Items For Information	The NACI liaison and ex officio representatives provided verbal updates on key emerging and ongoing issues of interest to NACI, taking place within their respective organizations
Administrative Updates For Information	The NACI Secretariat Canadian Immunization Guide (CIG) Team provided NACI with a verbal update on the development of the CIG COVID-19 Chapter to provide a shorter and simplified version of the NACI recommendations on COVID-19 vaccines. The NACI Executive Secretary provided an update on the tentative NACI COVID-19 workplan items for the rest of 2021 and early 2022 including further discussion on boosters, ongoing reviews of myocarditis, recommendations for previously infected individuals, pediatric recommendations, and potential new products Novavax and Medicago. The Executive Secretary also provided a summary of a recent discussion with the Council of Chief Medical Officers of Health on the priority items for NACI review in coming months.
Forward Approach for Boosters For Discussion	The NACI Chair and Vice-Chair led a discussion with NACI members and liaison representatives on possible approaches the committee could take on the matter of booster doses for the broader population and select subgroups.
Evidence on Boosters for Immunocompromised Population who have Received 3^rd Dose For Information / Discussion	The NACI Secretariat provided a presentation on booster dose evidence for moderately to severely immunocompromised individuals who have completed a 3-dose primary series of COVID-19 vaccines. Following the presentation, the committee discussed the evidence as well as the information needs required to further discuss and make a decision on the issue. The item will be brought back for decision at the next meeting.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) November 2, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Health Canada Regulatory Update For Information	Health Canada provided both pre- and post-market updates for COVID-19 vaccines.
Presentation: NACI Pediatric COVID-19 Vaccine Statement For Information	The NACI Secretariat presented the proposed statement on pediatric COVID-19 vaccine as well as the policy questions for NACI discussion and decision.
Discussion / Decision: Pediatric Recommendations For Approval	Following the presentation, the committee discussed the available evidence. The committee voted on recommendations for the use of the Pfizer-BioNTech COVID-19 vaccine in children aged 5 to 11 years, including consideration of the interval between doses. The NACI Secretariat will update proposed recommendations to reflect discussion and decisions by the committee, and will re-circulate to NACI for final review and approval following the meeting including refinements on clinical issues.

October 2021

**National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) October 27, 2021**
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Vice-Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Influenza 2022-23 Statement For Information and Decision	The NACI Secretariat provided an overview of the proposed updates to the 2022-2023 NACI Influenza Statement, which encompasses new information and guidance on influenza vaccination in the context of COVID-19, and new recommendations on the use of the seasonal influenza vaccines. Following the presentation of evidence and considerations for each new recommendation, these were discussed by the committee and consensus was reached on recommendations.

**National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) October 26, 2021**
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Health Canada Regulatory Update For Information	Health Canada provided both pre- and post-market updates for COVID-19 vaccines.
Vaccine Safety Working Group Update on General Activities For Information	The NACI Vaccine Safety Working Group Chair provided an update on working group activities, discussions and planning.
NACI Liaison Representative and Ex-Officios Updates on Key Items For Information	The NACI liaison and ex officio representatives provided verbal updates on emerging and ongoing issues of interest to NACI, taking place within their respective organizations.
Presentation: Consideration of potential pediatric programs For Information	The NACI Secretariat presented the policy questions for NACI discussion and consideration. An overview of COVID-19 disease severity and risk factors, as well as epidemiological trends in children were presented. The evidence to inform benefits and risks of a COVID-19 vaccine in children ages 5 to 11 was presented to inform NACI discussion including modeling and epidemiology, and the vaccine characteristics of safety and immunogenicity. NACI also discussed programmatic considerations of equity, ethics, feasibility, and acceptability.
Discussion: Consideration of potential pediatric programs	Following the presentation, the committee discussed the evidence provided as well as implications for NACI's upcoming recommendations on pediatric COVID-19 vaccines for children aged 5 to 11 years. The committee discussed additional information needed to help inform discussions on this issue, and will revisit evidence and consider recommendations at an upcoming NACI meeting.

**National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) October 15, 2021**
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Booster Recommendations for Key Populations For Discussion and Decision	The committee members discussed the available evidence and considerations, and implications on NACI COVID-19 booster dose recommendations for key populations. Key populations include older adults, recipients of a COVID-19 viral vector vaccine series, Indigenous populations and healthcare workers with very short intervals. The committee voted on recommendations for an mRNA COVID-19 booster dose in key populations.

**National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) October 12, 2021**
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Health Canada Regulatory Update For Information	Health Canada provided both pre- and post-market updates for COVID-19 vaccines.
Vaccine Safety Working Group Update on General Activities For Information	The NACI Vaccine Safety Working Group Chair provided an update on working group activities, discussions and planning.
NACI Liaison Representative and Ex-Officios Updates on Key Items For Information	The NACI liaison and ex officio representatives provided verbal updates on emerging and ongoing issues of interest to NACI, taking place within their respective organizations.
Presentation: COVID-19 Booster Framework For Information	The NACI Secretariat provided an update on COVID-19 booster dose evidence and recommendations. This update included an overview of the existing provincial/territorial and international recommendations on booster doses, populations to consider, considerations to maximize the benefit of a booster dose, and the interval between a primary series and a booster dose.
Booster Framework and Booster Recommendations For Discussion/Decision	Following the presentation, the committee discussed key populations to include in NACI's guidance for boosters, and vaccine intervals and dosage. The committee voted on recommendations for a COVID-19 booster dose in key populations, and will convene again to further discuss potential need for other populations as evidence evolves. NACI underscored the importance of continued emphasis on the primary series.

September 2021

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) September 28, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Presentation: Optimal Primary Series 2-Dose Interval For Information	The NACI Secretariat provided an update on COVID vaccine effectiveness according to interval between doses and provided an overview of context, including current NACI and other National Immunization Technical Advisory Groups (NITAG) recommendations for primary series intervals.
Presentation: Decision Framework for Boosters For Information	The NACI Secretariat provided an update on the decision framework for booster dose recommendations. Evidence for booster dose recommendations such as highlights from epidemiological reports, data on vaccine protection, jurisdictional scans, and ethics/equity/feasibility/acceptability (EEFA) considerations were provided.
Discussion: Decision Framework for Boosters, and Optimal Primary Series 2 Dose Interval For Discussion / Decision	Following the presentations, the committee discussed the implications of the evidence on current NACI recommendations for COVID-19 primary series intervals. The committee reached a consensus on next steps and additional information needed to inform further discussion on the issues of intervals and boosters at future meetings.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) September 21, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Presentation: Mixed Booster Trial Results For Information	Presenters from the National Institutes of Health (NIH) in the United States provided an update on the results from their multicenter Heterologous Platform Boost Study. Following the presentation, meeting participants were invited to ask questions.
Health Canada Regulatory Status Update For Information	Health Canada provided both pre- and post-market updates for COVID-19 vaccines.
Presentation: Booster Dose for Viral Vector Vaccines For Information	The NACI Secretariat provided an update on the duration and extent of vaccine protection over time for viral vector COVID-19 vaccines in Canada and abroad. Ethical, equity, feasibility and acceptability (EEFA) considerations on this policy issue were presented to inform discussions on whether booster doses are required in individuals who have received a complete vaccination regimen with a viral vector COVID-19 vaccine.
Discussion: Booster Dose for Viral Vector Vaccines For Discussion	Following the presentation, the committee discussed information needs required to further discuss and make decisions on this issue.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) September 14, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Provincial Updates on Surveillance and Vaccine Effectiveness (VE) Data in Key Populations For Information	Presenters from three Canadian provinces, Ontario, British Columbia and Quebec, were invited to present updated vaccine effectiveness (VE) data. The presenters from Ontario, the Institut National de Santé Publique du Quebec and British Columbia Centre for Disease Control provided updates on two-dose vaccine effectiveness (VE) against COVID-19 in each province. Following the presentation, meeting participants were invited to ask questions to the presenters.
Presentation: Decision Framework for Booster Dose Recommendations For Information	The NACI Secretariat provided a presentation on a proposed decision framework for booster dose recommendations, with specific application to Long Term Care (LTC) residents and older adults in congregate living settings.
Decision: NACI Decision on Booster Dose for Long-Term Care (LTC) For Discussion/Decision	Following the presentations, the committee discussed the available evidence and considerations, and the implication of a recommendation for providing a booster dose in LTC residents. A consensus was reached by the committee following the discussion.
Presentation: Co-administration Evidence For Information	The NACI Secretariat provided an update on whether simultaneous administration of COVID-19 vaccines and other vaccines should be allowed and whether the interval between COVID-19 vaccines and other non-COVID-19 vaccines should be removed.
Decision: Co-administration Recommendation For Discussion/Decision	Following the presentation, the committee discussed recommendations on simultaneous administration of COVID-19 vaccines and other vaccines, including influenza vaccines and other routine vaccines.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) September 7, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Health Canada Regulatory Status Update For Information	Health Canada provided a regulatory status and post-market update on COVID-19 vaccines.
Presentation: Consideration and Context for Booster Doses For Information	PHAC provided an overview of current vaccine efficacy and effectiveness data, as well as information on additional doses/booster programs in other countries. Meeting participants received an overview of the various approaches and planning considerations for booster programs, and mechanisms in place to monitor and report on relevant data, in the goal of informing decisions on optimal timing of booster doses for key populations.
Presentation: Evidence Update on Long-Term Care (LTC) For Information	The NACI Secretariat provided an overview of the COVID-19 vaccine booster dose program objectives, current recommendations, international as well as Provincial/Territorial policies, a review of current evidence on booster dose programs for LTC residents, and a Public Health Ethics Consultative Group (PHEGC) report on the issue.
Discussion: Role of NACI in Booster Doses and Key Populations For Discussion	Following the presentation, NACI members discussed the implications of a recommendation for additional doses in key populations. Members deliberated on key questions surrounding optimal timing of booster doses for specific populations, and discussed the results of the Ethics Consultative Report and the equity/ethical principles therein. Some additional information will be compiled by the NACI Secretariat to help inform discussions at a future meeting on the issue of additional doses/boosters for key populations.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) September 1, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Presentation: Immunogenicity Evidence from Long-Term Care (LTC) in Canada For Information	The presenters from COVID-19 Immunity Task Force provided an update on the results of seven studies evaluating the serological response following COVID-19 vaccines in long-term care (LTC) home residents and health care workers (HCW) and family members of the LTC home residents who served as controls for the analysis. Following the presentation, meeting participants were invited to ask questions to the presenters.
Health Canada Regulatory Status Update For Information	Health Canada provided a regulatory status and post-market update on COVID-19 vaccines.
Presentation: Third Dose for Immunocompromised Populations Evidence Review For Information	The NACI Secretariat provided an overview of the current evidence related to a third dose for immunocompromised (IC) populations. An overview of the current epidemiology and vaccination status of IC populations, as well as efficacy and immunogenicity of a primary COVID-19 vaccine series were presented. Potential benefits and harms of an additional dose and ethical, equity, feasibility and acceptability (EEFA) considerations were provided in this presentation.
Decision: NACI Recommendation on Third Dose for Immunocompromised Populations For Discussion/Decision	Following the presentation, NACI members discussed the list of immunocompromising conditions to be included in a statement and voted on recommendations for a third-dose for specific IC populations.
Presentation: Consideration and Context for Booster Doses For Information	This item postponed to a future meeting date due to insufficient time for discussion.
Discussion: Role of NACI in Booster Doses and Key Populations For Discussion	This item postponed to a future meeting date due to insufficient time for discussion.

August 2021

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) August 10, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Canadian trial of third dose in transplant recipients For Information	The presenter from the University Health Network provided an update on the results from the Toronto randomized control trial assessing the use of a third dose of COVID-19 mRNA vaccine in solid organ transplant recipients.
Health Canada Regulatory Status Update: Regulator Perspective on Data and Timelines For Information	The presenter from Health Canada provided a regulatory status update on COVID-19 vaccines.
Precautions Regarding Previous History of Myocarditis For Discussion/Decision	The presenter from PHAC provided feedback from various groups regarding the precautions to consider for individuals with a history of myocarditis/pericarditis including the Canadian Pediatric Society, Canadian Cardiovascular Society, and the Special Immunization Clinic. After the presentation, the committee decided on the advice to be offered for people with a previous history of myocarditis not related to COVID-19 vaccination.
Discussion and Next Steps For Information	The presenter from the NACI secretariat provided an update on the NACI vote for the recommendation on mRNA COVID-19 Vaccines for Adolescents and outlined the next steps to the committee.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) August 3, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
US Perspective: Myocarditis in Adolescents and Consideration on Pfizer and Moderna For Information	The presenter from the Centre for Disease Control provided an update on myocarditis/pericarditis following mRNA COVID-19 vaccines in the United States.
PHAC Safety Update For Information	The presenter from PHAC's Vaccine Safety section provided an update on myocarditis/pericarditis events in Canada following mRNA vaccine.
Health Canada Regulatory Status Update: Regulator Perspective on Data and Timelines For Information	The presenter from Health Canada provided a regulatory status update on COVID-19 vaccines.
Epidemiological Perspective For Information	The Vaccine Safety Working Group Chair provided an epidemiological perspective of the myocarditis/pericarditis vaccine safety signal.
Immunizer perspectives: Myocarditis in Adolescents and Consideration on Pfizer and Moderna For Information	Presenters from the Special Immunization Clinic Network provided an overview of the work done by the network and cases of pericarditis and myocarditis following mRNA vaccine.
NACI Recommendation on mRNA COVID-19 Vaccines for Adolescents - Additional option For Discussion/Decision	NACI members discussed the emerging domestic and international myocarditis/pericarditis data in young adults, and implications for recommendations in the adolescent population, and how data should be communicated in the NACI statement. The committee voted on updated recommendations for use of mRNA vaccines in adolescents but consensus was not reached.
Next Steps For Information	NACI will reconvene to continue the discussions on the adolescent recommendations.

July 2021

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) July 27, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Myocarditis/Pericarditis and vaccines Information/Discussion	The presenter from the Ottawa Health Institute provided a verbal overview on myocarditis and pericarditis following COVID-19 immunization in adults. The presenter from SickKids Hospital in Toronto presented a case series on acute myocarditis following COVID-19 vaccination in adolescents and young adults.
Administrative Announcements For Information	The NACI Chair provided administrative announcements. The Chief Public Health Officer thanked NACI members for their extraordinary work to date and ongoing commitment to immunization in Canada.
Health Canada Update For Information	The presenters from Health Canada provided a regulatory status update and post-market update on COVID-19 vaccines.
Presentation: mRNA COVID-19 Vaccines for Adolescents For Information	The presenter from the NACI secretariat provided an overview of NACI's current guidance on mRNA COVID-19 vaccination for the adolescent population and the proposed recommendations for the committee's consideration.
For Decision: NACI Recommendation on mRNA COVID-19 Vaccines for Adolescents For Discussion/Decision	Following the presentation, NACI members and attendees discussed how the recommendations for the adolescent population should be communicated in the NACI statement. The committee voted on new recommendations for use of mRNA vaccines in adolescents.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) July 20, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests Agenda approval For Information / Approval	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Health Canada Update For Information	Health Canada provided a regulatory update on COVID-19 vaccines in Canada, including Moderna's adolescent submission and safety update on myocarditis/pericarditis.
PHAC Safety Update For Information	The PHAC Vaccine Safety section provided information on cases of myocarditis/pericarditis following COVID-19 vaccination in Canada.
NACI 2021-2022 Workplan For Information / Discussion	The NACI Executive Secretary provided a summary of the NACI 2021-2022 workplan, to obtain feedback from committee members on the prioritization of proposed items for NACI advice.
Administrative updates from NACI Secretariat For Information / Discussion	The NACI Executive Secretary provided an update on current status and next steps for NACI's advice to PHAC for those vaccinated abroad with COVID-19 vaccines.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) July 13, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests Agenda approval For Information / Approval	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Health Canada Update For Information	Health Canada provided a regulatory update on COVID-19 vaccines in Canada.
PHAC Update: Cycle 2 of the COVID-19 Vaccination Coverage Survey (CVCS) For Information	The presenter from PHAC provided an update on results from cycle 2 of the COVID-19 Vaccination Coverage Survey (CVCS) conducted by PHAC, including insights on knowledge, attitudes, and beliefs around COVID-19 vaccines and vaccine acceptability according to different demographics. Following the presentation, meeting participants were invited to ask questions to the presenter.
Recommendations for individuals vaccinated abroad For Decision	The NACI Chair provided an update on the results of the electronic survey circulated to members regarding their preference on the various recommendations for individuals vaccinated abroad with non-Health Canada (HC) authorized COVID-19 vaccines. Outstanding issues were discussed and decided upon by the Committee.
NACI Process: Survey Results For Discussion	The NACI Executive Secretary provided a brief summary of the survey results to measure voting members' satisfaction on NACI processes, products, and methods adopted over the course of the COVID-19 pandemic. Following the summary of survey results, there was discussion with NACI members on further feedback and areas of improvement in processes and methods.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) July 9, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests Agenda approval For Information / Approval	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Presentation: COVID-19 Vaccine Guidance for Individuals Vaccinated Abroad For Information	The NACI Secretariat provided an update on the recommendations for individuals vaccinated abroad with non-Health Canada authorized vaccines. An overview was provided on context and considerations related to individuals vaccinated in other countries with COVID-19 vaccines not authorized by Health Canada and coming to live, work and/or study in Canada, which was followed by an overview of current evidence and proposed approaches for recommendations on this issue.
Discussion: COVID-19 Vaccine Guidance for Individuals Vaccinated Abroad For Discussion	Following the presentation, there was discussion with NACI members on the potential approaches for recommendations for individuals vaccinated abroad. Following the meeting, the NACI Secretariat will follow up with members of the committee to decide on recommendations for the issue of vaccination abroad with non-HC authorized vaccines.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) July 8, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests Agenda approval For Information / Approval	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Ontario Safety Data Update For Information	The presenter from the Public Health Ontario (PHO) Vaccine Safety team provided an update on provincial data on myocarditis and pericarditis following vaccination with a COVID-19 mRNA vaccine.
Institut national de santé publique du Québec (INSPQ) Committee Update For Information	The presenter from INSPQ provided an update on the risks and benefits of vaccinating people aged 12 to 39 with COVID-19 mRNA vaccines in in Quebec.
Health Canada Update For Information	Health Canada provided a verbal regulatory update on COVID-19 vaccines in Canada and an update regarding myocarditis and pericarditis and mRNA COVID-19 vaccination was provided.
Presentation: Updates on mRNA COVID-19 Vaccines for Adolescents and Myocarditis/ Pericarditis For Information	The NACI Secretariat provided an overview of updated data on what is currently known and unknown regarding myocarditis/pericarditis following mRNA COVID-19 vaccine in adolescents and young adults. The PHAC Vaccine Safety section provided an update on cases of myocarditis/pericarditis in Canada. The current and proposed NACI Recommendations for the use of mRNA COVID-19 vaccines in adolescents were presented.
Discussion: mRNA COVID-19 Vaccines for Adolescents For Discussion/Decision	Following the presentations and updates provided at this meeting, committee members discussed the evidence and its implications on current and future NACI guidance on the use of mRNA COVID-19 vaccines in adolescents. The committee agreed to continue to monitor the international and domestic data on the signal before deciding on a recommendation.

June 2021

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) June 30, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests Agenda approval For Information / Approval	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Presentation: COVID-19 Vaccine Guidance for Individuals Vaccinated Abroad For Information	The NACI Secretariat provided a presentation on guidance for vaccination of individuals who received COVID-19 vaccines outside of Canada that are not authorized by Health Canada. An overview was provided on jurisdictional and international guidance on COVID-19 vaccines received abroad.
Discussion: COVID-19 Vaccine Guidance for Individuals Vaccinated Abroad For Discussion	Following the presentation, committee members discussed the World Health Organization (WHO) regulatory process for COVID-19 vaccines as well as evidence, acceptability and ethical considerations for this guidance. Committee members will reconvene this discussion and a decision on guidance following this meeting.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) June 29, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests Agenda approval For Information / Approval	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Presentation: Heterologous COVID-19 vaccine schedule study For Information	The presenter from the Oxford Vaccine group in the United Kingdom (UK) provided an update on a study on the immunogenicity and reactogenicity of the COVID-19 vaccine heterologous prime/boost schedules administered at a 4-week interval.
Presentation: CANVAS Dose schedule for previously infected For Information	The presenter from the Canadian National Vaccine Safety Network (CANVAS) provided an update on vaccine safety data from the network related to the vaccination of individuals previously infected by SARS-CoV-2.
Presentation: Dose schedule for previously infected For Information	The NACI Secretariat provided an overview of recent evidence on COVID-19 vaccination in individuals who have had previously confirmed SARS-CoV-2 infection. Considerations to frame discussions on recommendations for individuals with a history of previous infection were provided to help inform decision points for the committee.
Discussion: Dose schedule for previously infected For Discussion	Following the presentations and updates provided, committee members discussed the evidence and its implications on NACI guidance for COVID-19 vaccination for individuals with previous SARS-CoV-2 infection. The NACI Secretariat will update the statement summarizing recent evidence on vaccination of individual with previously confirmed SARS-CoV-2 infection and recommendation will be updated to reflect discussion and decisions by the Committee.
Health Canada Regulatory Status Update For Information	Health Canada (HC) provided a verbal update on labelling modifications to the product monographs (PM) for COVID-19 vaccines.
PHAC Safety Update For Information	The PHAC Vaccine Safety section provided a verbal update on Canadian rates for myocarditis and pericarditis related to mRNA COVID-19 vaccination.

**National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) June 24, 2021**
Agenda Item	Summary
Welcome and Introduction Declaration of Interests Agenda approval For Information / Approval	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Presentation: Optimal Dosing Interval for COVID-19 Vaccine For Information	To help inform discussions at an upcoming meeting of Chief Medical Officers of Health, PHAC provided an overview of evidence on optimal dosing interval for COVID-19 vaccines for informal feedback from NACI members.
Discussion: Optimal Dosing Interval for COVID-19 Vaccine For Discussion	Following the presentation, NACI members provided feedback on optimal dosing intervals for homologous/heterologous COVID-19 vaccine schedules. NACI will continue to discuss optimal intervals as further evidence emerges.
Update from Health Canada For Information	Health Canada (HC) provided a brief verbal regulatory update on COVID-19 vaccines.
Update on ACIP discussion on Myocarditis/Pericarditis following mRNA COVID-19 vaccines For Information	The NACI Secretariat provided an update on emerging evidence of myocarditis/pericarditis in adolescents following mRNA COVID-19 vaccines, including a summary of the June 23, 2021, US Centers for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP) meeting discussions and evidence on the topic and CDC benefit-risk analysis.
Discussion: mRNA COVID-19 Vaccines for Adolescents and Myocarditis/ Pericarditis For Discussion/Decision	Following the presentations and updates provided at this meeting, committee members discussed the evidence and its implications on current and future NACI guidance on the use of mRNA COVID-19 vaccines in adolescents. NACI was clear that the overall benefit of an adolescent vaccine program continues to outweigh risk. The NACI Secretariat will update the recommendation to reflect discussion and decisions by the Committee, and will re-circulate for NACI for review and approve following the meeting.

**National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) June 22, 2021**
Agenda Item	Summary
Welcome and Introduction Declaration of Interests Agenda approval For Information / Approval	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Presentation: Public Health England Dose 2 Effectiveness Data Update For Information	The presenter from Public Health England (PHE) provided updates on comparative effectiveness and immunogenicity data following the first and second dose of Pfizer and AstraZeneca (AZ) COVID-19 vaccines at different intervals. Following the presentation, meeting participants were invited to ask questions to the presenter.
In-camera Discussion For Discussion	Following the presentation and updates provided, committee members discussed next steps and planned discussions for the next NACI meeting scheduled for Thursday, June 24, 2021.

**National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) June 21, 2021**
Agenda Item	Summary
Welcome and Introduction Declaration of Interests Agenda approval For Information / Approval	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Discussion: Global Considerations for Vaccine Recommendations For Information / Discussion	The NACI Secretariat provided update on a global equity perspective regarding the use of COVID-19 vaccines in adolescents, including NACI's mandate and historical approach to domestic versus international perspectives.
Presentation: Framing NACI guidance on mRNA COVID-19 vaccines for adolescents For Information	To help inform potential approaches to NACI recommendations for the use of mRNA COVID-19 vaccines in adolescents, the NACI Secretariat provided an update on COVID-19 vaccine coverage in adolescents, emerging evidence and surveillance on Myocarditis/pericarditis following COVID-19 vaccination, international guidance on mRNA COVID-19 vaccines for adolescents, and the status of current COVID-19 vaccination programs for adolescents across provinces and territories.
Discussion: mRNA COVID-19 Vaccines for Adolescents For Discussion / Decision	Following the presentations and updates provided at this meeting, committee members discussed the evidence and its implications on current and future NACI guidance on the use of mRNA COVID-19 vaccines in adolescents. The committee came to a consensus that they will reconvene this discussion and decision following the Advisory Committee on Immunization Practices (ACIP) meeting on June 23, where there will be new data presented on myocarditis and discussions on COVID-19 mRNA benefit-risk analyses pertaining to the adolescent population. A NACI Meeting has been schedule on June 24, 2021 to focus on this evidence review and decision.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) June 15, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests Agenda approval For Information / Approval	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Health Canada Regulatory Status Update For Information	Health Canada (HC) provided a brief regulatory status and safety update on COVID-19 vaccines in Canada, including updates on ongoing reviews of myocarditis/pericarditis and capillary leak syndrome (CLS).
PHAC Safety Update For Information	The PHAC Vaccine Safety section provided a verbal update on thrombosis with thrombocytopenia syndrome (TTS), myocarditis/pericarditis, Guillain-Barré Syndrome (GBS) and capillary leak syndrome (CLS) in Canada following COVID-19 vaccination.
Presentation: Update on Myocarditis/Pericarditis following mRNA COVID-19 vaccines For Information	The NACI Secretariat provided an update on myocarditis and pericarditis international evidence following mRNA COVID-19 vaccines.
Presentation: Framing NACI guidance on mRNA COVID-19 Vaccines for Adolescents For Information	NACI Secretariat provided an update on possible guidance on Moderna mRNA COVID-19 vaccine for adolescents in the event of an authorisation. The presentation covered the review of clinical trial efficacy findings, vaccine coverage and burden of COVID-19 in adolescents, ethics/equity/feasibility/acceptability considerations, and options for NACI guidance on the use of mRNA vaccines in adolescents (12 to 17 years of age).
Discussion: mRNA COVID-19 Vaccines for Adolescents and Myocarditis/Pericarditis For Discussion/Decision	Following the presentations and updates provided at this meeting, committee members discussed the evidence and its implications on current and future NACI guidance on the use of mRNA COVID-19 vaccines in adolescents. The committee came to a consensus that they will reconvene this discussion and decision next week with benefit of further analyses.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) June 9, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests Agenda approval For Information / Approval	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Presentation: Epidemiological impact of adult COVID-19 vaccination program on adolescents and children in Israel For Information	The presenter from the Israel Ministry of Health provided an update on adolescent COVID-19 disease rates, and observed cases of myocarditis following Pfizer COVID-19 vaccination in Israel. Following the presentation, meeting participants were invited to ask questions to the presenter.
Discussion on Myocarditis For Discussion / Decision	Due to time constraints, the discussion on Myocarditis recommendations will be held at the next NACI meeting on June 15, 2021.
ACIP Co-Administration Recommendation Update For Information	The presenter from Centres for Disease Control (CDC) provided an update on the Advisory Committee on Immunization Practices (ACIP) decisions regarding the co-administration of COVID-19 vaccines with other vaccines.
Health Canada Regulatory Status Update For Information	The presenters from Health Canada (HC) provided a regulatory update on COVID-19 vaccines.
Introduction of New NACI Member and Liaisons For Information	The NACI Chair provided an update on the new NACI voting member and liaison representatives. These new members were welcomed to the committee and introduced themselves, including a liaison representative for the Indigenous Physicians Association of Canada (IPAC); the Canadian Pharmacists Association (CPhA); and the Canadian Indigenous Nurses Association (CINA).
Presentation: Co-Administration of COVID Vaccines with Other Vaccines For Information	The presenters from PHAC provided an update on COVID-19 vaccines and concurrent administration with other vaccines. An overview was provided on international and domestic recommendations, recommendations from professional organizations, current evidence on the topic, forthcoming trials evaluating simultaneous administration of vaccines, and anticipated benefits/harms associated with co-administration of COVID-19 vaccines with other vaccines.
Discussion on NACI Recommendation on Co-administration of COVID Vaccines with Other Vaccines For Discussion/Decision	Following the presentation, the Committee deliberated on whether to change current guidance on co-administration of COVID-19 vaccines with other live or inactivated vaccines, including any exceptions to the routine policies. The committee was in favour of maintaining current recommendations at this time, with the addition of several exceptions where co-administration could be considered. This will prevent misattribution of any adverse events to other vaccines. The NACI Secretariat will update the recommendation to reflect discussion and decisions by the Committee, and will re-circulate for NACI for review and approve following the meeting.
Discussion on Vaccine Interchangeability Next Steps For Discussion	PHAC shared additional evidence to inform NACI recommendations on the interchangeability of COVID-19 vaccines. The Committee deliberated on the implications of this emerging evidence on the current NACI recommendations on interchangeability. Following the meeting, the NACI Secretariat will recirculate the recommendation options for further NACI deliberation and decision.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) June 1, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Health Canada Regulatory Status Update For Information	The presenter from Health Canada (HC) provided a regulatory update on COVID-19 vaccines.
PHAC Safety Update For Information	The PHAC Vaccine Safety surveillance unit provided an update on international reports of myocarditis and pericarditis following vaccination with COVID-19 mRNA vaccines and current myocarditis cases counts in Canada following COVID-19 vaccination, in relation to background rates. The presenter also provided a summary of Guillain-Barre Syndrome (GBS) cases following COVID-19 vaccination in Canada, in relation to background rates.
Updates and discussion on myocarditis following mRNA COVID-19 vaccine For Information	NACI Secretariat provided an evidence update on myocarditis following mRNA COVID-19 vaccination and NACI's role in addressing this emerging topic was discussed.
Presentation: Information needs for COVID-19 Vaccines in Pediatric Populations For Information	NACI Secretariat provided an overview of the current COVID-19 vaccine supply and potential rollout for the pediatric population if authorized, and summarized the burden of COVID-19 disease in pediatric populations. Anticipated policy questions, proposed options for the recommendations, and ethics/equity/feasibility/acceptability considerations were also presented, as well as proposed modelling scenarios to inform NACI guidance on the use of COVID-19 vaccines in pediatric populations.
Discussion: Information needs for COVID-19 Vaccines in Pediatric For Information	NACI discussed the relative merits of modelling to inform upcoming decisions on pediatric vaccine programs for COVID-19. There was general consensus that modelling would not be central to decisions.

May 2021

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD), May 26 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Mixed schedules/ interchangeability update for authorized COVID-19 vaccines For Information	NACI Secretariat provided an update on NACI's COVID-19 vaccine interchangeability recommendations, including an overview of safety studies on mixed schedules.
Update on heterologous COVID-19 vaccine schedule study, Spain (CombiVacS study) For Information	The presenter from The Carlos III Health Institute (ISCIII) in Madrid provided an update on the CombiVacS phase 2 randomized, multicenter, adaptive trial to evaluate the safety and immunogenicity of Comirnaty (Pfizer BioNTech) in subjects that had received one dose of Vaxzeveria (Oxford-AstraZeneca).
Health Canada Update: Regulatory Status For Information	The presenter from Health Canada (HC) provided a regulatory update on COVID-19 vaccines.
Discussion on NACI mixed-schedule / interchangeability of authorized COVID-19 vaccines recommendation For Discussion and Decision	Following the previous presentations, NACI discussed a recommendation on the interchangeability of the authorized COVID-19 vaccines (also referred to as "mixed vaccine schedules") in a two-dose primary series schedule for COVID-19 immunization in Canada. The committee came to a consensus on discretionary recommendations to allow interchangeability of authorized COVID-19 vaccines.
Next Steps For Information	The next NACI meeting is on June 1, 2021.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD), May 18 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Presentation: Media Approach For Information	The presenter from Health Canada (HC) provided a brief overview on media relations and shared an update on NACI approach to media engagement, including how to approach requests for interviews.
Presentation: Adverse Events Update - Vaccine Safety For Information	PHAC provided an update on adverse events related to COVID-19 vaccines.
Health Canada Update: Myocarditis International Perspective For Information	Health Canada (HC) provided an update on the regulatory perspective regarding reports of myocarditis following Pfizer COVID-19 vaccination internationally.
Presentation: Vaccine Administration Errors For Information	The presenter from PHAC provided an update on a document PHAC is developing that addresses management of vaccine administration errors (i.e. practices that differ from the recommendations provided in products monographs and by NACI). The recommendations provided in this guidance document are recommendations from PHAC, not NACI. The main topics were presented to the group for their expert input on the issues being considered for the document.
Q&A: Vaccine Administration Errors For Discussion	Following the previous presentation, NACI members provided input into the proposed recommendations from PHAC.
Next Steps For Information	The next NACI meeting is on May 26, 2021.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD), May 13 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
NACI Communications Approach For Information	The NACI Chair led discussion outlining the committee's workload and a planned request that PHAC be responsible for communication of NACI recommendations to the public, aiming for sustainability.
Health Canada update For Information	Health Canada provided an update on the regulatory status and timelines for several COVID-19 vaccines.
Immunocompromised and Autoimmune Populations For Discussion/Decision	The NACI Secretariat provided an evidence update on the immunization of special populations: immunosuppressed, autoimmune, pregnancy & breastfeeding, updated from the previous discussion on May 4. NACI members agreed on proposed edits for the special populations recommendations.
Discussion: Extended Intervals Recommendation For Information	The NACI Secretariat provided an overview of the recommendations on extended intervals for COVID-19 vaccine.
Discussion: Extended Intervals Recommendation For Discussion/Decision	Following the presentation, NACI members deliberated on and agreed to a modified recommendation on extended intervals. A vote was held and members were in agreement with the proposed recommendations for extended intervals.
Next Steps For Information	The committee will reconvene on Monday, May 18, 2021.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD), May 4 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Presentation: Heterologous COVID-19 vaccine schedule study For Information	The presenter from the University of Oxford provided an update on interim COM-COV data comparing the safety of heterologous versus homologous prime/boost schedules administered at a 4 week interval.
Presentation: Recommendation on Mixed Vaccine Schedules For Information	NACI Secretariat provided an overview of current recommendations on mixed schedules for different COVID-19 vaccine platforms.
Discussion: Recommendation on Mixed Vaccine Schedules For Discussion	Following the presentation, the committee members discussed and deliberated on the clarity of the messaging.
Presentation: Vaccine Safety on rate of VITT in Canada For Information	PHAC provided an update regarding Thrombosis with Thrombocytopenia Syndrome (TTS) in Canada.
Presentation: Pregnancy/Breastfeeding, Immunocompromised and Autoimmune Populations For Information	PHAC and the NACI secretariat provided an evidence update on vaccine use in pregnant/breastfeeding, autoimmune and immunocompromised persons; and the proposed recommendations for each group to consider for the forthcoming COVID-19 statement.
Discussion: Pregnancy/Breastfeeding, Immunocompromised and Autoimmune Populations For Discussion/Decision	Following the presentation, the committee members deliberated on changing the strength of the preferential recommendation for mRNA vaccines in pregnant/breastfeeding persons. Following the presentation on immunocompromised persons and those with an autoimmune condition, it was decided that decisions on recommendations for these populations would be deferred to next week following a review of evidence on extended intervals.
Next Steps For Information	The committee will continue their deliberations on Monday, May 11, 2021.

April 2021

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) April 26, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Presentation: Janssen Benefit-Risk Recommendations For Information	NACI Secretariat provided an update on the current context for Janssen, an overview of the benefit-risk analysis, and the proposed NACI recommendations for the Janssen vaccine.
Discussion: Janssen Benefit-Risk Recommendations For Discussion / Decision	Following the presentation, NACI members deliberated on the proposed NACI recommendations. Majority of voting members voted in favor of aligning the AstraZeneca and Janssen vaccines, recommending that use can be considered in individuals 30 years of age and older with informed consent, based on epidemiological context, and considering time to mRNA vaccine availability for each age group.
Next Steps For Information	The next NACI Meeting is scheduled for Monday, May 4, 2021.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) April 20, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved. The NACI Chair provided an update regarding a new sensitivity analysis that has been added to the AstraZeneca (AZ) vaccine statement, surrounding ICU data based on a worst-case provincial scenario.
Janssen Benefit-Risk Recommendations For Discussion / Decision	NACI Secretariat presented a benefit-risk analysis by age group, recommendations on the use of viral vector COVID-19 vaccines and ethics, equity, feasibility and acceptability (EEFA) considerations. The committee will continue their deliberations on Monday, April 26, 2021.
Pregnancy Update For Information	NACI Secretariat presented an update on COVID-19 vaccination during pregnancy and breastfeeding as well as NACI's forthcoming COVID-19 pregnancy and breastfeeding recommendations. The NACI Secretariat will update the NACI recommendations evidence on safety of COVID-19 vaccination in pregnant/breastfeeding women.
Presentation: Recommendation for action when minimum interval between COVID-19 vaccines doses is not adhered to For Discussion / Decision	NACI Secretariat presented an update on recommendations for vaccine minimum intervals. NACI Secretariat will consult with immunologists from the group to address the issue of administering doses earlier than the authorized interval in a future NACI statement.
Presentation: Revision of AstraZeneca Recommendations For Information	NACI Secretariat presented updates to the AstraZeneca benefit-risk analysis using a revised analysis integrating the latest ICU data. Based on these updates, NACI recommended that AstraZeneca may be offered in individuals 30 years of age and older with informed consent, depending on the epidemiological context, and considering the time to mRNA vaccine availability for each age group. There was discussion with NACI members on this proposed recommendation to offer the AZ vaccine to individuals 30 years and above without contraindications, who do not wish to wait for an mRNA vaccine. Members voted in favor of maintaining the threshold of 30 years and above
Next Steps For Information	The next NACI Meeting is scheduled for Monday, April 26, 2021.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) April 17, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests	The NACI Chair welcomed participants to the meeting.
Discussion on AstraZeneca recommendation For Discussion / Approval	NACI discussed principles of ethics, equity, feasibility, and acceptability in relation to the AstraZeneca vaccine induced immune thrombotic thrombocytopenia safety signal. The committee voted in favour of a benefit-risk framework to inform jurisdictions and individuals about the relative benefits and risks of AstraZeneca vaccine while waiting for mRNA supply, which varies across age groups.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) April 15, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Presentation: Vaccine Supply Update, Risk Benefit Analysis, Epidemiological Update For Information	The presenter from the NACI Secretariat provided an update on Canada's vaccine supply, an overview of the benefit-risk assessment and proposed recommendations on the use of COVID-19 vaccines.
Update from CDC on ACIP For Information	The presenter from the Centers for Disease Control (CDC) provided an update on the discussions held at the April 14, 2021 CDC-Advisory Committee on Immunization Practices (ACIP) meeting.
Discussion on AZ and Janssen Recommendations For Discussion/Decision	NACI members discussed: What age restrictions (if at all) does NACI now want to set for the use of AstraZeneca (AZ) vaccine (currently recommended in people 55 years or older only)? Voting members agreed to determine the age cut-off over which the risk/benefit for the use of the AZ vaccine is warranted, based on COVID-19 epidemiology. The age cut-off will be determined once NACI reviews the updated modelling analysis.
Next Steps For Information	NACI Secretariat will conduct a new modelling analysis for AZ and the updated analysis and recommendations will be circulated to NACI members by email.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) April 13, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests Agenda approval For Information / Approval	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Presentation: Health Canada assessment of AZ Terms and Conditions For Information	The presenter from the Marketed Health Products Directorate (MHPD) at Health Canada provided an update on Health Canada's progress on the safety assessment of the AstraZeneca (AZ) vaccine. The report and decisions were said to be expected shortly.
Presentation: Update on AstraZeneca For Information	The presenters from the NACI Secretariat presented an update on the vaccine induced immune thrombotic thrombocytopenia (VITT) situation in Canada, the epidemiology of COVID-19 in Canada, COVID-19 vaccine supply in Canada, and ethics, equity, feasible, acceptability considerations and associated implications on NACI COVID-19 vaccine recommendations.
Discussion: Discussion on AZ and Janssen For Discussion/Decision	Following the presentation, the committee members discussed the implications for NACI's recommendations on the use of both AstraZeneca and Janssen vaccines. To further inform this discussion at the next meeting, PHAC will prepare a benefit-risk epidemiological analysis of severe outcomes by age group adjusted by wait time to get mRNA vaccine.
Next Steps For Information	The committee will continue their deliberations on Thursday, April 15, 2021.

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) April 1, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests Agenda approval For Information / Approval	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Presentation: Previously infected Healthcare workers preliminary data For Information	The presenter from the University of Montreal provided an overview of a Canadian study which examines the immune correlates of SARS-CoV-2 protection and the immunological response to the first dose of the Pfizer vaccine in healthcare workers previously infected with SARS-CoV-2.
Presentation: CANVAS data on Dose 1 of previously infected cases For Information	The presenter from the Canadian National Vaccine Safety (CANVAS) Network provided an overview of Canadian data on active safety surveillance following dose 1 of a COVID-19 vaccine in individuals previously infected with SARS-CoV-2.
Discussion: Dosing schedule for previously infected For Discussion/Decision	Following the information provided in the previous presentations, the committee discussed recommendations on vaccination of individuals previously confirmed to be infected with SARS-CoV-2. The Committee determined that there was insufficient evidence at this time, on the effectiveness of only one vaccine dose and no safety signal in terms of reactogenicity after the first dose that would require or support a change in recommendation to the dosing schedule for previously infected individuals.
Presentation: Data of breakthrough cases after one dose in Manitoba First Nations communities For Information	The presenter from the Manitoba First Nation Pandemic Response Team provided a summary of data on COVID-19 cases following immunization with first or second doses in First Nations Communities in Manitoba. An overview of the vaccine rollout to date in First Nations communities in Manitoba was provided. NACI considered how this information related to recommendations under development for extended dose intervals, to be published April 7.

March 2021

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) March 30, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests Agenda approval For Information / Approval	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Presentation: Intervals Statement For Discussion	PHAC provided an update on vaccine effectiveness (VE) data derived from the NACI extended dose intervals statement, and implications for scenario modelling. Following the presentation from PHAC, the Committee discussed the proposed recommendations on the extended interval between COVID-19 vaccine doses. PHAC will update modelling to reflect the most current vaccine effectiveness estimates.
Discussion: AstraZeneca safety status and next steps, implications for Janssen update For Discussion	The NACI Chair provided an update on the AstraZeneca safety signal status and next steps, and PHAC provided an overview of implications for the NACI Statement recommendations. Based on the presentation provided, the Committee discussed the implications of this information on current and upcoming NACI recommendations.
Next Steps For Information	The NACI Executive Secretary provided an overview of next steps and timelines for the anticipated publication of the NACI statement and other upcoming updates.

**National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) March 24-25, 2021**
Agenda Item	Summary
Welcome and Introduction Declaration of Interests Agenda approval For Information / Approval	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Presentation: Updated VE for dose 1 in United Kingdom For Information	The presenter from Public Health England (PHE) provided updated data on one dose vaccine effectiveness (VE) of the Pfizer BioNTech and AstraZeneca COVID-19 vaccines.
Presentation: Updated VE for dose 1 in Quebec For Information	The presenter from the Institut national de santé publique du Québec (INSPQ) provided an update on surveillance-based assessment of the effectiveness of a single dose of COVID-19 vaccine in healthcare workers and long-term care facility residents in Québec.
Presentation: Safety on AstraZeneca - European Medicines Agency (EMA) Review For Information	PHAC provided an update on the recent AstraZeneca COVID-19 vaccine safety signal (risk of thrombosis and thrombocytopenia). The presentation covered summaries of the European Medicines Agency (EMA) statement (dated March 18, 2021), information from the Paul-Erlich Institut in Germany, recommendations from Regulatory Agencies, and National Immunization Technical Advisory Groups (NITAGs).
Discussion: Safety of AstraZeneca For Discussion	Based on the presentation provided, the Committee discussed the available evidence and implications for the current NACI recommendations and statement.
Presentation: Janssen Recommendations For Information	PHAC highlighted key issues for discussion and provided an evidence summary to inform proposed changes to NACI COVID-19 vaccine recommendations.
Discussion: Janssen Recommendation For Discussion	Based on the presentation provided, the Committee discussed the evidence and proposed recommendations on the use of the Janssen COVID-19 vaccine. Following the discussion, NACI members will be sent a revised draft statement via email for review.
Presentation: Intervals Statement For Information	PHAC provided an update on the newly available immunogenicity evidence to consider whether any specific populations should be identified for shorter intervals in the upcoming extended intervals statement.
Discussion: Intervals For Decision	Based on the presentation provided, the Committee discussed the complexity of evidence and implications for the extended intervals recommendation.
Next Steps For Information	The NACI Executive Secretary provided an overview of next steps and timelines for the anticipated publication of the NACI Statements and other upcoming updates.

**National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) March 16, 2021**
Agenda Item	Summary
Welcome and Introduction Declaration of Interests Agenda approval For Information / Approval	The NACI Vice-Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Presentation: Janssen data updates and proposed recommendations For Information	PHAC provided an update on NACI COVID-19 Guidance and recent evidence for Janssen viral vector vaccine.
Discussion on proposed Janssen recommendations For Discussion / Decision	Based on the presentation provided, the Committee discussed the evidence and proposed recommendations on the use of the Janssen COVID-19 vaccine. Members agreed that further work on the recommendations is required and this will be brought to the next NACI meeting for discussion.
Exceptions to extended intervals and timing of statement For Information	The NACI Vice-Chair provided an update on the forthcoming NACI Statement which will outline the full supporting evidence for NACI Recommendations on extended intervals. At a future NACI meeting the committee will deliberate on emerging data from risk groups to consider whether shorter intervals may be warranted.

**National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) March 10, 2021**
Agenda Item	Summary
Welcome and Introduction Declaration of Interests Agenda approval For Information / Approval	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved. The NACI Chair informed the committee of the launch of the NACI economic process consultation process. The results of this public consultation will have significant impact on shaping NACI's health economics processes moving forward.
AstraZeneca age cap: vaccine effectiveness and recommendation review For Information	PHAC presented an overview of recently published evidence from three non-peer reviewed pre-prints publications on AstraZeneca vaccine effectiveness in the UK population.
Discussion on AstraZeneca age cap For Discussion / Decision	Based on the presentation provided, the Committee discussed the recommended age range for the AstraZeneca COVID-19 vaccine and came to a consensus to expand the age range to 18+ for the AstraZeneca vaccine, while continuing to monitor new evidences, as they emerge.
Vaccination in those with previous COVID-19 infection: Review of rationale and proposed recommendation For Information	PHAC provided a presentation on vaccination of individuals who have had previously PCR-confirmed SARS-CoV-2 infection. The presentation provided an overview of the current NACI recommendation on vaccination of individuals with previous infection, international recommendations on the dosing intervals and number of doses for individual with previous infection, and current safety, efficacy, and immunogenicity data.
Discussion on Vaccination in those with previous COVID-19 infection For Information	Following the presentation, NACI member deliberated on the proposed recommendations for vaccination of individuals who have had previously PCR-confirmed SARS-CoV-2 infection. The proposed recommendation will continue to be discussed at a future meeting, when additional Canadian safety data are available to inform the discussion and ultimate decision.
Presentation: Janssen Data Updates and proposed recommendations For Information	This item postponed to a future meeting date due to insufficient time for discussion.
Discussion on proposed Janssen recommendations For Discussion	This item postponed to a future meeting date due to insufficient time for discussion.
Next Steps For Information	The NACI Executive Secretary provided an overview of next steps and timelines for the anticipated publishing of the NACI statement and other upcoming updates.

February 2021

National Advisory Committee on Immunization (NACI) Summary of Discussion (SOD) February 24-25, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests Agenda approval For Information / Approval	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved.
Public Health England (PHE) Vaccine Effectiveness Follow-up Data For Information	The presenter from PHE provided an update on vaccine effectiveness and impact of the Pfizer and AstraZeneca COVID-19 vaccines in the targeted vaccinated groups.
Institut national de santé publique du Québec (INSPQ) Vaccine Effectiveness Follow-up Data For Information	The presenter from INSPQ provided an overview on the data of the surveillance-based assessment on the effectiveness of a first dose of the COVID-19 vaccine in health care workers (HCWs) and long term care facilities (LTCF) residents in Québec.
British-Columbia Centre for Disease Control (BCCDC) Vaccine Effectiveness Data For Information	The presenter from BCCDC provided an overview of the effectiveness of a first dose of the COVID-19 vaccine in health care workers (HCWs) and long term care facilities (LTCF) residents in British Columbia.
Regulatory Update on AstraZeneca For Information	Health Canada provided an update on the regulatory status of the AstraZeneca COVID-19 vaccine and a related vaccine from the Serum Institute of India.
Discussion on AstraZeneca For Discussion and Decision	PHAC presented an overview of one AstraZeneca COVID-19 vaccine effectiveness study as well as studies looking at emerging evidence on the efficacy of the COVID-19 vaccine against variants of concern. Based on the presentation provided, the Committee discussed the recommended age range for the AstraZeneca COVID-19 vaccine and came to a consensus to maintain their previous planned recommendations, while continuing to monitor new evidence, as they emerge.
Modeling data on COVID-19 vaccine intervals versus introduction of new vaccine For Information	PHAC provided preliminary results from a vaccine infectious disease model comparing the impact of extending dose intervals to 12 or 24 weeks versus not extending for an mRNA vaccine campaign with/without the introduction of the AstraZeneca vaccine.
Intervals for mRNA COVID-19 vaccines and on COVID-19 vaccine program For Discussion and Decision	The presenter provided an overview of the proposed policy question for consideration and current NACI interval recommendations. The clinical efficacy, effectiveness summary & immunogenicity, along with the ethics/equity/feasibility/acceptability (EEFA) considerations were presented. Members deliberated on revised interval recommendations and came to a consensus.
Vaccine schedule for previously infected For Discussion	This item postponed to a future meeting date due to insufficient time for discussion.
Next Steps For Information	The NACI Executive Secretary provided an overview of next steps and timelines for the anticipated publishing of the NACI statement and other upcoming updates.

National Advisory Committee on Immunization (NACI) Summary of Discussion February 18, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests Agenda approval For Information / Approval	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved
Vaccine updates and policy questions For Information	PHAC provided updates to the committee on COVID-19 vaccine regulatory reviews and estimated timelines, and put forward policy questions for consideration and discussion.
Allocation decisions and supply management For Information	PHAC provided an overview of upcoming vaccine supply, options for sequencing and allocation, supply management considerations and considerations for a delayed second dose.
Discussion of Presented Information For Discussion	Participants discussed the existing evidence and public health rationale for extended dose intervals.

National Advisory Committee on Immunization (NACI) Summary of Discussion February 8, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests Agenda approval For Information / Approval	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. Meeting agenda was reviewed and approved
Public Health England (PHE) Vaccine Effectiveness Data Presentation For Information	The presenter provided an overview of data sources, limitations, risks of bias and preliminary vaccine effectiveness (VE) for the Pfizer BioNTech COVID-19 vaccine roll-out in the United Kingdom.
Institut national de santé publique du Québec (INSPQ) Vaccine Effectiveness Presentation For Information	The presenter provided an overview of data sources, limitations, risks of bias and preliminary vaccine effectiveness (VE) for the COVID-19 vaccine roll-out in Quebec healthcare workers (HCW) and long-term care facility (LTCF) residents.
Israel Vaccine Effectiveness Data Analysis For Information	PHAC provided an overview and analysis of a recent Israeli study of Pfizer-BioNTech vaccine effectiveness.
Discussion of Presented Evidence For Discussion	NACI members discussed the presented evidence in the context of current and imminent COVID-19 vaccine recommendations. The committee expressed interest in hearing updates from PHE and INSPQ, as well as from other provinces in Canada, when more data is available regarding the VE stability for one dose protection as more weeks accumulate.
Next Steps For Information	The NACI Executive secretary provided updates on the approval status, embargo copy distribution and publishing of upcoming NACI COVID-19 publications. The next planned NACI meeting is scheduled for February 24 and 25, 2021 from 1:00 - 3:00 PM EST.

National Advisory Committee on Immunization (NACI) Summary of Discussion February 5, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest.
AstraZeneca COVID-19 use in Seniors: International Recommendations and Evidence For Information	The NACI Secretariat presented an overview of the international regulatory decisions and recommendations from National Immunization Technical Advisory Groups (NITAG) related to appropriate age ranges for the AstraZeneca COVID-19 vaccine, which included a summary of the evidence surrounding efficacy, immunogenicity and modeling.
Recommended Age Range for use of AstraZeneca COVID-19 Vaccine For Discussion / Approval	Based on the previous presentation, the Committee discussed the recommended age range for the AstraZeneca COVID-19 vaccine and came to a consensus. Recommendations will be finalised via electronic feedback in coming days.

January 2021

National Advisory Committee on Immunization (NACI) Summary of Discussion January 28, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest.
AstraZeneca COVID-19 Vaccine Evidence - Update For Discussion	NACI secretariat presented an update on AstraZeneca COVID-19 Vaccine Evidence which included updated efficacy evidence and analysis of potential anti-vector responses.
AstraZeneca COVID-19 Vaccine Recommendations Background Information Overall populations recommendation Administration and special population recommendations For Approval	NACI Secretariat presented options for AstraZeneca COVID-19 Vaccine Recommendations. Members discussed public health factors and the implications of integrating AstraZeneca vaccine into the mRNA vaccine programs already underway in Canada. Members reached consensus on appropriate ages and intervals, and discussed potential recommendations for populations and how this vaccine might be used in context of other available options in the event the AstraZeneca vaccine is authorised by Health Canada. NACI will consider recommendations on other clinical issues through later approvals.
Prioritization of COVID-19 Vaccine Recommendations For Information	NACI Secretariat presented Guidance on the Prioritization of Key Populations for COVID-19 Vaccination for stage 2 and 3 of vaccine rollout. NACI members and liaison members will be sent revisions via email for approval, following discussion with the Federal/Provincial/Territorial Special Advisory Committee.
Tuberculin Skin Test and COVID-19 Vaccine For Approval	There was insufficient time to discuss this item during the meeting. Materials will be emailed to NACI members for review and approval.
Allergenic Events Following COVID-19 mRNA Vaccines For Approval	NACI Vaccine Safety Working Group Chair presented on updates to potential allergens for COVID-19 vaccines, and NACI approved proposed changes.

National Advisory Committee on Immunization (NACI) Summary of Discussion January 19, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest.
Phase 2 Information Brief For Information	Public Health Agency of Canada presented an initial orientation to the vaccine distribution plan within Canada for the second quarter of 2021, as well as information about a collaborative survey with FPT jurisdictions on their allocation intentions.
Prioritization Approach and Preliminary Evidence For Discussion	NACI Secretariat presented evidence and options to consider for priority groups to vaccinate in stage 2 vaccine rollout and beyond. NACI will revisit discussion on January 28, with the intention to finalise prioritisation advice for future stages of vaccine rollout.
AstraZeneca COVID-19 Vaccine Approach Evidence Summary For Information	NACI Secretariat presented available efficacy and immunogenicity evidence for the AstraZeneca COVID-19 Vaccine, following a recent presentation on safety at the NACI Vaccine Safety Working Group. NACI will revisit evidence and consider recommendations on January 28.
Tuberculin Skin Test and COVID-19 Vaccine For Approval	This item was moved to the January 28, 2021, NACI meeting.
COVID-19 Vaccine Allergens For Approval	This item was moved to the January 28, 2021, NACI meeting.

National Advisory Committee on Immunization (NACI) Summary of Discussion January 7, 2021
Agenda Item	Summary
Welcome and Introduction Declaration of Interests	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest.
Evidence and Management Options Table for Extended Interval between COVID-19 Vaccine Doses For Approval	NACI Secretariat presented an evidence summary related to extended dose intervals for mRNA vaccines. NACI approved proposed changes, including precision around evidence-informed extended intervals.
Updates to COVID-19 Recommendations for Special Populations For Approval	NACI Secretariat presented proposed revised wording for special population recommendations to improve clarity for clinical decision-making. NACI approved changes.
Updates on Outstanding Issues For Information	NACI Secretariat presented an update on outstanding issues and the NACI forward agenda.
Final Comments For Information	NACI Secretariat and Health Canada provided updates on the status of COVID-19 vaccine submissions and anticipated timelines for regulatory decisions.

December 2020

National Advisory Committee on Immunization (NACI) Summary of Discussion December 17, 2020
Agenda Item	Summary
Welcome Declaration of Interests RODs from November 25, 20202 & December 4 & 7, 2020 For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. One voting member was recused from decisions.
Clinical evidence for Moderna COVID-19 vaccine- Update For Discussion	NACI Secretariat presented an update on additional interim analyses of vaccine efficacy and new safety data from Phase 3 clinical trials for the Moderna COVID-19 Vaccine.
COVID-19 Vaccine Recommendations-Moderna Update For Approval	The NACI Secretariat presented the NACI evergreen Statement: Recommendations on the use of COVID-19 Vaccines (Moderna Update) to members for their review. This included consideration of how to integrate Moderna vaccine into recommendations, in the event of regulatory authorisation, in addition to clarifications in the special population recommendations (pregnancy, breastfeeding, immunocompromised, autoimmune) in response to questions from jurisdictions and frontline immunizers. NACI approved proposed recommendations.
EEFA-Ethics Scenario based Analysis for Delayed Second Dose For Discussion	NACI Secretariat presented the ethics, equity, feasibility, acceptability (EEFA) analysis to members, based on input from the Public Health Ethics Consultative Group. The analysis will be included as an appendix in the next iteration of the statement.

National Advisory Committee on Immunization (NACI) Summary of Discussion December 14, 2020
Agenda Item	Summary
Welcome and Introduction Declaration of Interests	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. One voting member was recused from decisions. Agenda was approved.
Presentation of clinical evidence for Moderna COVID-19 vaccine For Discussion	NACI Secretariat provided members with an overview of clinical evidence for the Moderna COVID-19 vaccine.
Discussion of emerging policy/clinical questions Extended interval between doses Intervals around pregnancy Autoimmune disorders For Discussion	NACI Secretariat presented on emerging policy questions relating to special populations, and considerations which will inform provincial/territorial risk management of vaccine supply.

National Advisory Committee on Immunization (NACI) Summary of Discussion December 7, 2020
Agenda Item	Summary
Welcome and Introduction Declaration of Interests Update on Knowledge Translation activities for NACI's COVID-19 vaccine guidance For Information	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest.
COVID-19 Vaccine Recommendations For Approval	Proposed recommendations for COVID-19 vaccines, and specifically for the Pfizer-BioNTech COVID-19 vaccine, were presented to members. Recommendations were approved with adjustments. Recommendations covered topics such as recommended age groups, recommended dosing intervals, immunization of those previously infected with SARS-CoV-2, immunization of special populations (e.g. pregnancy, immunocompromised), and recommendations for continuity of public health measures in vaccine recipients.

National Advisory Committee on Immunization (NACI) Summary of Discussion December 4, 2020
Agenda Item	Summary
Welcome and Introduction Declaration of Interests	The NACI Vice-chair welcomed participants to the meeting and invited any new declarations of interest. Agenda was approved.
Update on status of COVID-19 vaccine submissions and authorizations For Discussion/Approval	NACI Secretariat provided members with anticipated timelines for regulatory decisions based on current submissions over coming months, while highlighting their impact on NACI's work moving forward.
Presentation of clinical evidence for Pfizer/BioNTech COVID-19 vaccine For Information	NACI Secretariat presented on the efficacy, immunogenicity and safety data for the Phase 3 clinical trial for the Pfizer-BioNTech COVID-19 vaccine. NACI members will receive a draft version of the COVID-19 Vaccine Statement which included vaccine-specific recommendations for the Pfizer-BioNTech COVID-19 vaccine, for their comments and feedback.

November 2020

National Advisory Committee on Immunization (NACI) Summary of Discussion November 25, 2020
Agenda Item	Summary
Welcome and Introduction Declaration of Interests Records of Decision	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest. The record of decision from November 13, 2020, was approved by members.
Indigenous Recommendations For Discussion/Approval	PHAC sought clarification from NACI on previous discussions of Indigenous communities in the allocation of initial COVID-19 vaccine doses. NACI confirmed their support to broadly prioritise Indigenous communities for equity, ethical, and epidemiological reasons. NACI also discussed healthcare workers, and clarified that healthcare workers would not all be prioritised in the first stage of vaccine rollout, but initial prioritisation would focus on those whose work involves direct contact with patients.
Process for Urgent NACI Approval For Information	The NACI Chair discussed the process and expectations of NACI members when seeking urgent endorsement or approval on a document in the pandemic context. Future processes will focus on rapid input from voting members.
Proposed COVID-19 Statement Template For Approval	NACI Secretariat presented a statement template which was approved by NACI members. The statement will be one base statement that is evergreen and contains all COVID-19 recommendations, similar in structure to chapters of the Canadian Immunization Guide, accompanied by a series of appendices which will contain detailed evidence. NACI approved the proposed COVID-19 vaccine statement template.
Key Policy Questions and Critical Outcomes for COVID-19 Guidance For Feedback/Approval	NACI Secretariat presented key policy questions that will guide recommendation development for the first iteration of the NACI COVID-19 guidance. NACI approved the list of policy questions with some additions.
Health Canada Rolling Submission and Evidence Standards For Information	Health Canada presented to NACI on the mechanics of a rolling submission, Interim Order Authorization and proposed evidence standards for COVID-19 vaccines.

National Advisory Committee on Immunization (NACI) Summary of Discussion November 13, 2020
Agenda Item	Summary
Welcome and Introduction	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest.
NACI's COVID-19 vaccine statement structure and continued role in vaccine prioritization decisions For Discussion	NACI Secretariat presented an overview of the proposed structure and framework for the development of NACI's anticipated statements on the use of COVID-19 vaccine(s), as well as the scope of NACI's role in high-level strategic sequencing of key populations for COVID-19 vaccine prioritization as complementary to the operational prioritisation and allocation that will occur at the Federal/Provincial/Territorial (F/P/T) level.
Presentation on vaccine rollout planning and allocation For Discussion	PHAC presented proposed operational distribution groups that are aligned with NACI's preliminary guidance, and considerations for COVID-19 vaccine planning and allocation stemming from F/P/T discussions. NACI generally supported the F/P/T allocation plans. NACI provided further analysis and reaction to the proposed operational distribution groups in the days following this presentation, informed by foundational principles of their published Preliminary guidance on key populations for early COVID-19 immunization. NACI identified issues including equity across racialized groups, epidemiology and exposure risk, disease risk, and the importance of reviewing clinical safety and efficacy data to identify appropriate age groups and special populations (e.g. pregnancy). Pending clinical trial results data, NACI recommended the following groups be considered for early 2021 allocation planning: Residents and staff of long-term care, assisted living, retirement homes, and chronic care hospitals Individuals of advanced age (starting with 80 years and expanding by 5-year increments to age 70 years as doses become available) Health care workers, considering exposure risk Indigenous communities NACI identified that communication of vaccine prioritization decisions will be important to ensure trust in the recommendations and improve uptake of the vaccine. NACI did not make recommendations on prescriptive sequencing of these groups beyond what is described above.

August 2020

Summary of Discussion August 13, 2020 Meeting, Ottawa, Ontario
Agenda Item	Summary
Welcome and Introduction	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest.
Dose Sparing Strategies for Seasonal Influenza Vaccination For Discussion	The WG Chair and the NACI Secretariat presented evidence from two rapid reviews.
NACI Recommendations on the Duration of the Post-Vaccination Observation Period during the COVID-19 Pandemic For Discussion	External experts from the Vaccine Safety WG were included for this discussion. NACI discussed the evidence base and recommendations, coming to consensus on the fact that maintaining an observation time of 15 minutes should be prioritised when possible. Recommendations to be approved electronically following the meeting.
*PHAC interim guidance on use of Influenza Vaccine during COVID-19 Pandemic* website** For Information	**Due to time constraints, this item was not presented nor discussed.*
COVID-19 Vaccine Planning -COVID-19 Vaccine landscape and federal planning activities -Vaccine advance purchase agreements and procurement priorities For Information	NACI Secretariat presented an overview of the COVID-19 Vaccine Development Landscape as well as adaptions to the typical vaccine pathway. Roman Suzumski, VP- COVID-19 Vaccine Procurement, provided an overview of Canada's COVID-19 vaccine procurement strategy.
COVID-19 pandemic immunization strategies and target groups for potential COVID-19 vaccines For Discussion -Objective of the NACI statement on pandemic immunization strategies and target groups for potential COVID-19 vaccines -Findings of the ARCHE rapid review on risk factors for severe COVID-19 infection -Update on COVID-19 epidemiology in Canada -Results of the expert stakeholder survey ranking the relative importance of COVID-19 pandemic immunization strategies -Draft NACI statement on pandemic immunization strategies and target groups for potential COVID-19 vaccines	NACI Secretariat presented the objectives and structure of the interim NACI statement on target groups for early COVID-19 vaccination, after which Alberta Research Centre for Health Evidence presented findings of their review on risk factors for sever COVD-19 infection. An update was also provided on the epidemiology of COVID-19 in Canada and results of the stakeholder survey were presented. The results will be used to inform the development of guidance on recommended target groups for early COVID-19 vaccination. NACI members discussed options, but consensus was not achieved, and the committee agreed to convene again in one week to finalise recommendations.

June 2020

Summary of Discussion June 11, 2020 Ottawa, Ontario
Agenda Item	Summary
Welcome and Introduction	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest.
CIG Update For Information	The NACI Executive Secretariat provided the committee with web-publishing updates to the CIG. Updates were provided on revisions to CIG chapters.
COVID-19 For Information	The purpose of this item was to present the COVID-19 vaccine clinical trial landscape, modelling approach as well as on outline for vaccine targeting guidance.
Influenza For Information	The Influenza Working Group Chair presented the revised workplan and NACI Secretariat presented on seasonal influenza vaccination, post-vaccination observation period, and on the hypothesis of influenza vaccine interference with COVID. The outline of the Guidance for Influenza Vaccine Delivery in the Presence of COVID-19 was also shared with members.
Economics Update For Information	The purpose of this presentation was to update NACI on work being done by the Economics Task Group.
COVID-19/BCG For Information	The purpose of this presentation was to inform and discuss BCG clinical trials and potential immunological arguments for off-target prevention of COVID-19.
NACI Workplan For Discussion	The purpose of this presentation was to provide NACI members with an adjusted 2020-2021 workplan for discussion. The committee agreed to take a conservative approach to the workplan for the next year in anticipation of increasing demands for COVID-19 vaccine work.

February 2020

Summary of Discussion February 5-6, 2020 Ottawa, Ontario
Agenda Item	Summary
Welcome and Introduction	The NACI Chair welcomed participants to the meeting and invited any new declarations of interest.
General Business For Information	The NACI Executive Secretariat provided the committee with administrative updates, including implications of secretariat staff working on the novel coronavirus.
Mumps Statement For Approval	The purpose of this item was to present the draft mumps Statement to members for review. NACI had previously reviewed the Statement at the September 2019 meeting, and input had since been integrated from provinces and territories. Members approved the Statement in principle pending final edits.
GRADE For Information	The purpose of this item was to provide an overview of the rationale and next steps for NACI's transition to GRADE methodology.
Pneumococcal Working Group Update For Information	The purpose of this item was to update NACI members on the status of the Working Group, and provide anticipated timelines for the statement.
Vaccine Supply Update For Information	Members received an update on current and anticipated vaccine supply issues.
Ethics, Equity, Feasibility, Acceptability Presentation For Information	The purpose of this presentation was to provide members an update on current EEFA activities and present the results of two vaccine acceptability public opinion research surveys conducted with the general public and health care providers.
RSV- Statement and Evidence For First Review	The draft statement for RSV and palivizumab was presented to members for first review. Consensus was achieved for most recommendations, but the committee asked to further review evidence on the use of palivizumab in healthy term infants in Inuit communities at a future meeting.
Liaison and Ex-Officio Update For Information	Updates from Liaison and ex-officio members were provided from the following groups: MHPD, CNA, CPS, CPHA, ISC, AMMI Canada, SOGC, CAIRE, BGTD, NML
CIG Updates For Information	The NACI Secretariat provided members with an update on revisions to the Canadian Immunization Guide and web publishing.
Workplan 2020-2021 For Information	The NACI Secretariat led the committee in a workplan prioritization discussion and exercise. It was determined that the forward workplan should be flexible and conservative in anticipation of disruptions from the novel coronavirus.
NACI Economic Process For Discussion/Approval	The members were presented with the draft Economic Process for discussion and approval. The process outlines how and when economic evidence will be incorporated into NACI decision making. Two tools supporting the economic process were approved: Submission Criteria for Model-based Economic Evaluation and Presentation Template for Proposed Economic Evidence
Public Consultation Survey For Information	The task group chair presented on the Public Consultation Survey for the Economic Process.
Economic Guidelines Task Group Update For Information	The Task group chair provided an update to NACI members of the current work that has been accomplished since the last update in September 2019.

September 2019

Summary of Discussions September 25-26, 2019 Meeting, Ottawa, Ontario
Agenda Item	Summary
Welcome and Introduction	The NACI Vice-Chair welcomed participants to the meeting.
General Business For Information	The NACI Secretariat Manager provided the committee with administrative updates, including staffing changes at the NACI Secretariat.
Update on Economics Guidelines Task Group: For Information	The purpose of this update was to inform members of the ongoing progress of the Task Group.
Presentation template for systematic review of economic evaluations For Approval	NACI reviewed a presentation template to standardise presentation of systematic reviews of economic evaluation literature. Decision: The template was approved by NACI
Economic Process For Discussion	The purpose of this presentation was to gain NACI input on key questions regarding the NACI Economics Process and a proposed stakeholder consultation process. Decision: There was general support for multi-model comparisons where feasible, with the caveat that a more detailed approach be developed following consultation with the PHAC Public Health Ethics Consultative Group. This approach may allow for submission of models from vaccine industry to be compared to independent academic models.
Liaisons and Ex-Officios Updates For Information	Updates were provided by liaison and ex-officio representatives including: Association of Medical Microbiology and Infectious Disease Canada; Canadian Immunization Committee; the Centers for Disease Control Advisory Committee on Immunization Practices; Biologics and Genetics Therapies Directorate, Health Canada; Canadian Paediatrics Society; College of Family Physicians of Canada; Canadian Nurses Association; Public Health Ethics Consultative Group; the National Microbiology Laboratory; Marketed Health Products Directorate, Health Canada.
Influenza Working Group Update For Information	The purpose of this presentation was to provide an update on the ongoing progress of projects underway by the working group.
Supplemental Statement on Mammalian Cell-Based Influenza Vaccines For Approval	The purpose of this presentation was to discuss a draft Statement on mammalian cell-culture based influenza vaccines. The presentation included the methodology, results and conclusions of a systematic literature review on the efficacy, effectiveness, immunogenicity and safety. Decision: Members identified multiple areas for clarification, and the Supplemental Statement will be revised accordingly. The Secretariat will re-submit the amended Supplemental Statement via email for a second review and approval in early 2020.
NACI Mumps Working Group For First NACI Review	The Working Group Chair presented the proposed recommendations stemming from previous working group discussions and their rationale based on the previously presented evidence summaries. Decision: The working group will refine the epidemiology section of the statement, and the revised draft Statement will be sent for review by provinces and territories in late 2019 for stakeholder input.
Ebola Virus Disease (EVD) Guidance Update For Information	The purpose of this presentation was to update NACI on progress towards finalising interim recommendations on the use of the pre-market Ebola virus disease vaccine. Decision: N/A
High Consequence infectious disease working group workplan approach For Information	NACI created a new Working Group for High-Consequence Infectious Diseases (HCID). NACI Secretariat presented an overview of vaccine-preventable HCIDs and the proposed workplan for the HCID WG. Decision: Smallpox vaccine will be the next topic addressed by the new HCID WG.
Ethics, Equity, Feasibility, Acceptability (EEFA) Update For Information	This meeting marked the official launch of NACI's expanded mandate, including economic and EEFA factors. An update was provided on the status of EEFA methodological frameworks and a new algorithm outlining the process for consideration of EEFA programmatic factors by NACI. Decision: The EEFA tools will be prepared for publication
Early Vaccine Reactions Including Anaphylaxis For Approval	The purpose of this item was to seek approval from NACI on new recommendations being made to the CIG Part 2 chapter "Anaphylaxis and other Acute Reactions following vaccination". Decision: The NACI Executive will discuss next steps concerning revisions to the anaphylaxis management table prior to NACI approval.
Canadian Immunization Guide (CIG) and Webpublishing Update For Information	An update was provided on the recent web-publishing activities for CIG, including an overview of issues that will be addressed over the next few months. Decision: N/A
RSV Update and Workshop For Information	The purpose of this presentation was to inform NACI members of recent activities and next steps in RSV vaccine readiness. In spring 2019 PHAC hosted an RSV vaccine readiness workshop with Canadian RSV and surveillance experts. This activity identified several information and evidence gaps in the Canadian context, and the results of the workshop are being prepared for publication. Decision: PHAC will update NACI as vaccine readiness and surveillance planning evolves.
Vaccine Supply Update For Information	An update was provided by PHAC on a number of vaccine supply issues.
Adjournment	The Vice-Chair thanked members for their contributions and adjourned the meeting.

June 2019

Summary of Discussions June 5-6, 2019 Meeting, Ottawa, Ontario
Agenda Item	Summary
Welcome and Introduction	The Chair welcomed participants to the meeting.
General Business For Information	The NACI Executive Secretary provided the committee with administrative updates, including staffing changes at the NACI Secretariat.
Economics: Economic Guidelines Task Group Progress Update Overview of ETG Guidelines For Information	The purpose of this update was to provide members with the progress of the work being conducted with both Task Groups.
Economics: Standard Operating Procedure (SOP) for Systematic Review of Economic Evaluations For Approval	An overview of the Standard Operating Procedure (SOP) for the systematic review of economic evaluations was provided with the purpose of receiving feedback and approval from NACI. This standard operating procedure (SOP) outlines the best practices when conducting a systematic review of economic evaluations within NACI or by a contractor. This review will be used to inform NACI recommendations and will be published in the advisory committee statements. Decision: The SOP was approved by NACI
Economics: SOP for Reporting Guidelines For Approval	An overview of the Standard Operating Procedure (SOP) for the reporting of economic evaluations was provided. The purpose of the Reporting Guidelines is to provide guidance on how to report economic evaluations to NACI. It is to be used in house and by contractors. The objective of this presentation was to obtain feedback and approval on the SOP. Decision: The SOP was approved by NACI
Economics: Use of Economic Evidence from Industry For Discussion	A discussion took place on the parameters around the "use" or reliance on health economic evidence from industry, and acceptable extent of industry involvement in creating that evidence. Several options for a path forward were presented and discussed. Decision: Additional consultations on the issue will take place over the summer and fall of 2019. The Economics Task Group (ETG) and NACI Secretariat will develop a process outline over the summer in order to bring it to NACI in September 2019 for approval.
Vaccine Supply Update For Information	An update on current vaccine supply shortages was provided. This is a yearly presentation to support early engagement of a more formal process.
Influenza : Statement on LAIV use in HIV-infected individuals For Approval	The recommendations and statement on the use of LAIV were brought to NACI in February 2019 for review and approval. At that time, NACI requested the statement be reviewed by the Canadian Pediatric and Perinatal Aids/HIV Research Group. The updated recommendations were brought to NACI at this meeting for approval. Decision: The Statement was approved with some amendments
Influenza: 2020-2021 Seasonal Influenza Statement For Discussion	An overview of proposed changes to the Statement on Seasonal Influenza Vaccine for 2020-2021 was provided. Decision: The Influenza Secretariat will amend the Seasonal Statement as per the discussion and send a revised version via email to members later in June for their final approval.
Pandemic Prioritization Tool and Emergency Response Plan For Information	A presentation was provided on the Canadian Pandemic Influenza Preparedness Plan and the F/P/T Public Health Response Plan for Biological Events. Members were informed of a Pandemic Influenza Exercise that the Center for Emergency Preparedness and Response is currently working on multi-phased exercise which will take place over the course of 18 months in 2019-2020 with the support of CIRID. NACI was not part of the previous pandemic response, but NACI is now positioned to provide guidance going forward.
NACI MMRV Working Group: Mumps Focus For Information/Discussion	A progress update on the work of the Mumps Working Group was provided. The eventual statement is to include programmatic recommendations that will support the P/T goal of controlling the scale of mumps outbreaks in Canada by limiting the number of cases. An overview of the results of a survey to collect provincial and territorial data on the recent mumps outbreak activity was also presented.
NACI Trumenba^®Statement For Approval	The purpose of this item was to obtain the final vote on recommendations for the use of Trumenba^®for the prevention of Meningococcal B Disease. These recommendations were previously brought to NACI for review and approval, however upon reflection some members felt that there were elements of the statement that needed to be re-discussed. Decision: The recommendations were approved with some amendments.
Liaison Representative /Ex-Officio Updates For Information	Updates were provided by liaison and ex-officio representatives including the: Association of Medical Microbiology and Infectious Disease Canada; Canadian Immunization Committee; the Centers for Disease Control Advisopry Committee on Immunization Practices (CDC-ACIP); Biologics and Genetics Therapies Directorate, Health Canada; Canadian Paediatrics Society; College of Family Physicians of Canada; Canadian Nurses Association; Public Health Ethics Consultative Group; the National Microbiology Laboratory; Marketed Health Products Directorate, Health Canada; and National Defense and the Canadian Armed Forces.
RSV Working Group Update For Discussion	An overview of safety evidence and economic evaluations for Palivizumab were presented, and NACI discussed approaches to integrate this evidence into the NACI Statement under development.
Ethics, Equity, Feasibility, Acceptability (EEFA): Update on work-to-date For Information	An update was provided on the EEFA frameworks with a focus on acceptability. The acceptability matrix and the algorithm was provided. The presentation provided key highlights from research conducted on acceptability of vaccines in Canada. Decision: EEFA Framework and materials will be presented at September NACI meeting for the launch of NACI's expanded mandate. Materials will then be published online.
EEFA: Systematic review on acceptability in the context of EEFA For Information	Preliminary results from a systematic review of the factors that influence the acceptability of vaccines among Canadians was presented the University of Alberta contractor who conducted the review. Decision: The systematic review on vaccine acceptability will be published on NACI's website when completed.
CIG Guidance: MMR for Travelers Outside of North America For Information/Approval	The objective of this discussion was to gather input from NACI Members to inform revised draft wording on measles vaccine recommendations for travellers, before review by the Committee to Advise on Tropical Medicine and Travel (CATMAT). Decision: The measles traveller CIG text will be revised following input by CATMAT.
Overview of Federal EVD Response Capabilities For Information	An update on the current Ebola outbreak (2018-19) in the Democratic Republic of Congo (DRC) was presented; this included information on the epidemiology, international response, immunization, as well as the Canadian support.
EVD Working Group Update and Next Steps For Information/Approval	The objectives of the NACI EVD Vaccine Working Group and the critical path for the rapid development of interim guidance on the use of stockpiled EVD vaccine was provided. The findings of a rapid review on ring vaccination against EVD, as well as draft guidance considerations and options, were also presented.
Adjournment	The Chair thanked members for their contributions and adjourned the meeting.

February 2019

Summary of Discussions February 6-7, 2019 Meeting, Ottawa, Ontario
Agenda Item	SUMMARY
Welcome and Introduction	The Chair welcomed participants to the meeting.
General Business For Information	The NACI Executive Secretary provided the committee with some administrative updates, including staffing changes at the NACI Secretariat.
Influenza General Update For Information	The purpose of this presentation was for the Influenza Working Group (IWG) Chair to provide an update on ongoing and upcoming IWG projects that are currently planned for 2019-2020.
LAIV in HIV-infected individuals - Proposed recommendations For Approval	A presentation was provided on proposed Recommendations on the use of Live Attenuated Influenza Vaccine (LAIV) in HIV-infected Individuals for NACI review and approval. The guidance objective was to review the efficacy and effectiveness, immunogenicity, and safety evidence on LAIV use in HIV-infected individuals and to provide updated guidance on the use of LAIV in this population. Decision: The IWG will revise the statement according to NACI feedback received and an updated version will be brought to NACI for approval at the June 2019 meeting.
RSV Working Group For Information	The Working Group Chair provided an overview of WG activities since the NACI September 2018 meeting, with specific focus on the ongoing work to systematically review the RSV disease burden in infants and children. An update on the systematic review on cost-effectiveness of palivizumab for prevention of RSV was also provided.
Department of National Defense Update For Information	An overview of the Canadian Armed Forces Immunization Program was presented by Commander Kirsten Barnes (NACI Ex Officio).
Rabies Working Group - Overview of project plan For Information/Approval	The Rabies Working Group Chair provided a presentation of the Rabies Working Group project plan for NACI's consideration and endorsement. Decision: The project plan was approved by NACI
Liaison Representative /Ex-Officio Updates For Information	Updates were provided by liaison and ex-officio representatives including the: Association of Medical Microbiology and Infectious Disease Canada; Biologics and Genetics Therapies Directorate, Health Canada; Canadian Association for Immunization Research and Evaluation; Canadian Paediatrics Society; Council of Chief Medical Officer of Health; College of Family Physicians of Canada; First Nations and Inuit Health Branch, Indigenous Services Canada; the National Microbiology Laboratory; Marketed Health Products Directorate, Health Canada; National Defense and the Canadian Armed Forces; and Society of Obstetricians and Gynaecologists of Canada.
Presentation: Therapeutic Vaccines For Discussion	The Executive Secretary provided NACI with an overview on the emergence of therapeutic vaccines for infectious diseases (IDTVs). The objectives for this presentation were to provide an overview of the work done to date between Health Canada (HC), Canadian Agency for Drugs and Technologies in Health - (CADTH) and PHAC, highlight the challenge of determining which advisory body (NACI or CADTH) will provide guidance for some of these new products, discuss the next steps and the potential role for NACI. It was identified that there are approximately 100 IDTVs in various phases of clinical trial, and it is only a matter of years before a product receives authorisation. It was also noted that there is no anticipated role for NACI in therapeutic vaccine guidance for non-infectious diseases. Decision: This topic will be brought forward to NACI again when further progress has been made.
Mumps Working Group - Overview of project plan For Information/Approval	The Working Group Chair provided a presentation of the Mumps Working Group work done to date as well as the proposed Working Group project plan for NACI's consideration and endorsement. The objectives of the Working Group include individual-level recommendations (which will consider the optimal number and timing of doses for protection of individuals) and programmatic-level recommendations (which will consider the additional number and timing of doses for outbreak control and/or prevention). Decision: The project plan was approved by NACI
Presentation: Mumps Working Group - Canadian surveillance data collection update For Information	The Surveillance and Epidemiology Division (PHAC) provided an overview of the results of a survey to collect provincial and territorial data on the recent mumps outbreak activity. The results will support the work of the NACI Mumps Working Group to investigate the optimal use of the vaccine and the number of doses required in outbreak settings.
Vaccine Supply Update For Information	The Vaccine Supply & Assurance (VSA) - Centre for Immunization and Respiratory Infectious Diseases (CIRID), PHAC - provided NACI with information on current vaccine shortages and informed them of some supply scenarios where NACI advice might be sought.
NACI's role in Ebola Virus Disease Vaccine Guidance For Information/Discussion	NACI received a presentation on Ebola Virus Diseases (EVD) and NACI's potential role in issuing interim pre-market guidance. Options were presented on how guidance could be issued. Decision: NACI agreed to undertake the pre- and post-market EVD vaccine guidance
NACI Workplan For Discussion	The Executive Secretary presented NACI member feedback and CIC/CCMOH feedback on the draft 2019-20 NACI workplan. The priority level of potential workplan items was discussed, and final NACI input was solicited for workplan items for 2019-20. Decision: Once finalized, the workplan will be submitted to the Vice-President for approval. Once approved, the workplan will be circulated to NACI and other stakeholders (e.g. P/Ts), and will be posted to the NACI website.
Presentation: Primer - Making cents of economic evaluation For Information	NACI's health economist presented an overview of economic evaluations in general which included components of health economics, methods used to look at cost effectiveness, and interpreting the results.
Economics - Prioritization Tool For Information/Approval	The Economics Task Group Chair provided an overview of the Prioritization Guide to Economic Evidence. The purpose of this tool is to assess the need for economic evidence and the urgency for economic evidence. The purpose of the presentation was to obtain feedback and approval from NACI on this tool. Decision: NACI agreed to move forward with the application and refinement of the prioritization tool.
Economics - Interim guidelines For Information/Approval	The Economic Task Group Technical Leads provided a presentation to the committee on the Interim Guidelines for conducting economic evaluations. The purpose of these Interim Guidelines is to inform best practices for conducting de novo economic evaluations of vaccines in Canada. This is to ensure the economic information is standardized, credible, and relevant for decision-makers in Canada's publicly funded health care system. The objective of the presentation was to review and compare CADTH guidelines and the NACI Interim Guidelines, based largely on CADTH guidelines, and obtain feedback and approval for these NACI Interim Guidelines. Decision: The interim guidelines for economic evaluations of vaccines were approved by NACI.
Adjournment	The Chair thanked members for their contributions and adjourned the meeting.

September 2018

Summary of Discussions September 26-27, 2018 Meeting, Ottawa, Ontario
Agenda Item	SUMMARY
Welcome and Introduction	The Chair welcomed participants to the meeting.
Ethics, Equity, Feasibility and Acceptability (EEFA) - piloting and framework For Approval	NACI was presented the draft EEFA framework as well as an overview of the next steps, which included obtaining NACI approval to pilot this framework. The framework was approved for piloting.
Presentation: Indigenous Analysis and Engagement, and International Circumpolar Surveillance Network For Information	NACI was presented an overview of the work conducted on immunization data, programs, and recommendations for Indigenous populations in Canada and abroad. There was also a presentation on the International Circumpolar Surveillance Network, what it is, how it works and what information it collects as well as an overview of Invasive Bacterial Diseases data.
Influenza Working Group (IWG) For Information	An update on completed, ongoing and upcoming IWG projects to date was presented.
Presentation: Revised influenza vaccination program of Québec For Information	NACI received a presentation on the revision of influenza vaccination program in Québec from Dr. Rodica Gilca of l'Institut national de santé publique du Québec (INSPQ).
Presentation: Evaluation of new palivizumab immunoprophylaxis recommendations in Nunavik infants For Information	NACI received a presented on the evaluation of new palivizumab immunoprophylaxis recommendations in Nunavik infants from Dr. Rodica Gilca of the INSPQ.
Rabies Working Group (WG) For Approval	NACI approval of the interim guidance to the Department of National Defence (DND) on accelerated rabies pre-exposure prophylaxis (PrEP) regimens was sought. DND is seeking this guidance due to accelerated deployment schedules of its troops. NACI approved the interim guidance. The WG will begin developing updated recommendations on the use of rabies vaccine for PrEP, post-exposure prophylaxis (PEP), and in the context of PEP, guidance on the use of rabies immune globulin separately once this interim guidance to the DND is completed.
Presentation: Vaccine Supply Contingency Planning For Discussion	NACI was presented a plan for vaccine supply contingency planning and a discussion was held on what NACI's role could be.
NACI Guidance Development: Defining the Scope and Type of Review For Discussion	NACI was provided a presentation on the draft criteria that could be used to decide the appropriate scope and type of analysis for review of scientific data as well as the proposed next steps.
Pneumo Working Group (WG) Update For Decision	NACI was provided an update on the WG's work to date, including key elements considered by the WG. The work plan was presented for NACI final feedback and approval, and discussion on potential disease reduction targets and guidance from NACI were solicited. The workplan was approved.
Pertussis Working Group (WG) For Decision	NACI was provided an update on the WG's work to date, including key elements considered by the WG, and presented the work plan for NACI final feedback and approval. The workplan was approved.
Liaison Representative /Ex-Officio Updates For Information	Updates were provided by liaison and ex-officio representatives including the: Association of Medical Microbiology and Infectious Disease Canada; Biologics and Genetics Therapies Directorate, Health Canada; Canadian Association for Immunization Research and Evaluation; Canadian Paediatrics Society; Canadian Immunization Committee; Canadian Public Health Association; Centers for Disease Control and Prevention; First Nations and Inuit Health Branch, Indigenous Services Canada; Marketed Health Products Directorate, Health Canada; National Defense and the Canadian Armed Forces; and the National Microbiology Laboratory.
General Business For Information	The NACI Manager provided the committee with some administrative updates including some staffing changes at the NACI Secretariat.
Adjournment	The Chair thanked members for their contributions and adjourned the meeting.

June 2018

Summary of Discussions June 6-7, 2018 Meeting, Ottawa, Ontario
Agenda Item	SUMMARY
Welcome and Introduction	The Chair welcomed participants to the meeting.
PHAC Vice-President Remarks	The new PHAC Vice-President of the Infectious Diseases and Prevention Control Branch (IDPCB) welcomed participants to the meeting. The Vice-President discussed priorities for IDPCB and thanked NACI members for their hard work and dedication.
Meningococcal Working Group Statement on Trumenba^TM For Approval	The literature review methodology and key findings on the efficacy/effectiveness, immunogenicity and safety of Trumenba^TM were presented. NACI was also presented the draft Statement on The Use of Trumenba^TM for the Prevention of Meningococcal B Disease. The recommendations were approved by NACI.
Pneumococcal Working Group (WG) For Information	An update on WG objectives, potential disease reduction targets, and scope of epidemiological analysis were presented to NACI members for input and feedback.
Presentation: VPD Goals and Targets For Information	An update on Vaccine Coverage Goals and Vaccine Preventable Diseases (VPD) Reduction and Targets for Canada presented, with a focus on why goals and targets were updated for Canada, with discussions around the process on how to review, develop and attain endorsement of goals and targets.
Pertussis Working Group (WG) For Information	The updated work plan and next steps for the WG presented. Phase one of the pertussis strategy is now complete; the recommendations for Tdap immunization in pregnancy have been publicly available since March 2018. To confirm the next steps for phase two of the pertussis strategy, the WG will seek input from the Canadian Immunization Committee (CIC).
RSV Working Group (WG) For Information	The status of the review of the RSV burden of disease, the literature review of economic analyses of palivizumab use, safety data related to palivizumab use, the literature review on the effectiveness of Palivizumab use, and the potential availability of Canadian RSV data from the IMPACT RSV pilot project were presented.
Economics Task Group (ETG) For Information	NACI was provided with an update of ongoing committee activities and next steps. The Prioritization Tool was presented for feedback and approval from the committee to begin piloting the tool. Further work on the tool is required before piloting.
Measles Post-Exposure Prophylaxis (PEP) Recommendations For Approval	The Canadian Communicable Disease Report (CCDR) Summary of the Measles PEP Recommendations was presented for approval. The summary was approved.
Vaccination Strategies for Mumps Outbreaks For Discussion	The current Canadian surveillance (and its limitations) was presented and NACI's feedback was sought on the committee's objectives for work moving forward on mumps.
Influenza Working Group (IWG) Update For Information	An update on completed, ongoing and upcoming IWG projects to date was presented.
End-of Season Influenza Activity and Effectiveness for 2017-18 Season For Information	The Surveillance Epidemiology Division at PHAC provided an overview of surveillance finding for Canada for the 2017-2018 influenza season and an informal scan of vaccine effectiveness (VE) monitoring findings from the northern and southern hemispheres from the 2017-18 season.
Afluria Tetra Supplemental Statement For Approval	The supplementary Statement on the use of Afluria Tetra in adults and children was presented for review and comments on the proposed recommendation. The Statement was approved by NACI.
2019-2020 Influenza Statement For Discussion	The Review of Proposed Changes to the Statement on Seasonal Influenza 2019-2020 was presented to NACI for feedback. The reasoning behind this review is to address the current cross-product inconsistency; internal inconsistency; internal redundancies and length of the statement.
Canadian Immunization Guide (CIG) For Information	An update on the CIG web activity was presented to NACI. Work is currently being done with the digital communications group to improve web traffic and the overall user experience. The changes to come will not be content-based; they will focus on improving the look and feel of the web pages, and search optimization.
Liaison Updates For Information	Updates were provided by liaison and ex-officio representatives including the: Association of Medical Microbiology and Infectious Disease Canada; Biologics and Genetics Therapies Directorate, Health Canada; Canadian Association for Immunization Research and Evaluation; Canadian Paediatrics Society; Canadian Immunization Committee; Canadian Public Health Association; Centers for Disease Control and Prevention; First Nations and Inuit Health Branch, Indigenous Services Canada; Marketed Health Products Directorate, Health Canada; National Defense and the Canadian Armed Forces; and the National Microbiology Laboratory.
General Business For Information	The NACI Executive Secretary provided updates on the following: PHAC Updates; NACI Workplan; and SAGE and GNN
Adjournment	The Chair thanked members for their contributions and adjourned the meeting.

February 2018

Summary of Discussions February 7-8, 2018 Meeting, Ottawa, Ontario
Agenda Item	SUMMARY
Welcome and Introduction	The Chair welcomed participants to the meeting.
Herpes Zoster Working Group (HZ WG) Update and Objectives and key questions For Information	The WG Chair provided an update on the work to date of the WG andprovided information on past NACI recommendations for Live Zoster Vaccine (LZV) (2010, 2014) and the trigger for updating Statement (Authorization of new vaccine, Recombinant Zoster Vaccine (RZV)).
Herpes Zoster Vaccine Immunogenicity: Literature Review For Information	The primary objectives and results of the literature review on immunogenicity of HZ vaccines were presented to NACI.
Efficacy, Effectiveness and Safety Findings For Information	The efficacy, effectiveness and safety findings from studies on LZV and RZV were presented to NACI.
Economics For Information	The Working Group presented results on the economic analysis conducted on LZV and RZV. The methods and epidemiological parameters were reviewed.
Management Options Table and Recommendations For Decision	The Management Options Table for LZV vs RZV was presented. This table summarizes the evidence around key considerations for each vaccine and the decision points that help support the objective and answer key questions for the Statement. The recommendations were also presented to NACI for approval. Decision: The recommendations were approved.
Meningococcal Working Group Update For Information	The WG Chair provided an update on the work to date of the WG. The current priority of the WG is the Trumenba Statement.
Meningicoccal: Lab Epidemiology For Information	NACI received a presentation from the Surveillance and Epidemiology Division of PHAC on the epidemiology of IMD in Canada (focused on serogroup B disease). Presentation on the status of plans for conducting a systematic review of economic evaluations of meningococcal vaccines targeting serogroup B strains.
Meningicoccal WG: Systematic Review For Information	Work to date on the systematic literature review on Trumenba was presented.
Meningicoccal WG: Economic Presentation For Information	The WG presented the status of plans for conducting a systematic review of economic evaluations of meningococcal vaccines targeting serogroup B strains.
Economics Task Group (ETG)	The ETG Chair provided a detailed update on the work of the ETG. The current WG activities include setting a 2018-19 work plan and developing a prioritization tool.
Presentation: Maximizing the impact of immunization programs in Canada: Bridging the gap between research and policy update For Information	NACI received a presentation from Dr. Natasha Crowcroft on a framework which aims to assist with integration of research into policy.
Measles, Mumps, Rubella WG: Immunoglobulin use for Post Exposure Prophylaxis for Measles For Information	NACI received a presentation from the WG Chair on optimal dosing strategies for measles post exposure prophylaxis (PEP). A discussion was held on optimal dosing strategies for measles PEP. The WG will finalize PEP guidelines and bring back to NACI for a decision.
Measles, Mumps, Rubella WG: 2nd dose MMR For Information	NACI received a presentation that demonstrated the current varying provincial practices on dosing as well as epidemiologic data on outbreaks.
Influenza Working Group (IWG) Update For Information	The WG Chair provided update on completed and ongoing NACI IWG projects for fiscal year 2017-2018 as well as upcoming projects for fiscal year 2018-2019.
IWG: Vaccine Effectiveness For Information	The Surveillance Epidemiology Division at PHAC provided an update to NACI about the vaccine effectiveness (VE) status in Canada.
IWG Workplan: 2018-2019 For Decision	The 2018-2019 work plan was presented for approval. The working group proposed that they in addition to core activities i.e. development of the 2019-2020 Influenza Statement and evidence reviews for new products), the WG focus on conducting preparatory work in anticipation of the implementation of the expanded NACI mandate for influenza guidance, including economics. Decision: NACI approved the 2018-19 IWG workplan.
IWG: Effects of repeat annual influenza vaccination: Systematic review of systematic reviews For Information	The WG presented methodology and results of a literature review on the effects of repeated influenza vaccination were presented as well as the proposed recommendation on repeated influenza vaccination for NACI feedback.
IWG: Split vs Sub-unit Influenza Vaccine: Rapid Review For Decision	The methodology, results, and conclusions of the literature review on vaccine effectiveness and immunogenicity of subunit versus split virus inactivated influenza vaccine were presented for NACI approval. The initial database search retrieved 30 records after removal of duplicates; only three of these studies met inclusion criteria. After post-hoc adjustments to the study protocol, 41 unique studies were retrieved from the database search and eight were deemed eligible for inclusion based on the revised eligibility criteria. Decision: NACI approved the literature review.
Canadian Immunization Guide (CIG): General Update For Information	NACI was provided an update of CIG related activities since the September 2017 meeting.
CIG Part 2 - Vaccine Safety Working Group Update For Information	Committee received an update of the Vaccine Safety Working Group (VSWG) activities. The review of the egg allergy chapter has been completed. A second review of the Vaccine Safety chapter was deferred until the next WG teleconference. The new format for the safety section in Part 4 chapters (Active Vaccines) was presented for review by NACI.
CIG Part 3 For Decision	The WG Chair provided an update on Part 3 WG activities and sought feedback from the group on proposed changes. Decision: NACI approved the proposed changes to Part 3 of the CIG which included updates to the Immunization of Immunocompromised Persons, Immunization in Pregnancy and Breastfeeding and Immunization of Persons with Chronic Diseases chapters.
Pertussis Working Group For Information	The committee received an update on the pregnancy statement: advance copy was circulated on February 5, 2018 and will be web published at the end of February 2018. The WG will consult with the Canadian Immunization Committee and the Council of Chief Medical Officers of Health regarding priority setting for the next phase of the work.
Vaccine Supply Update For Information	NACI was presented information on current vaccine shortages, most of which are affecting the private market. Shortages include, Adacel^®Polio; Adacel^®; Menactra^®; Pediacel^®; Vaqta^®(adult & ped.); Havrix^®(adult and ped.); Engerix-B^®(adult); Recombivax HB^®(adult).
Liaison Updates For Information	Updates were provided by liaison and ex-officio representatives including the: Association of Medical Microbiology and Infectious Disease Canada; Canadian Association for Immunization Research and Evaluation; Canadian Immunization Committee; Canadian Paediatrics Society; Canadian Immunization Committee; Council of Chief Medical Officers of Health; First Nations and Inuit Health Branch, Health Canada; Marketed Health Products Directorate, Health Canada; and Society of Obstetricians and Gynaecologists of Canada.
General Business For Information	NACI was provided information on changes within the NACI Secretariat.
RSV Working Group General Update For Information	The committee received an update on the WG activities. The plan for the RSV WG is to create three products: a literature review on the effectiveness of anti-RSV antibody (Palivizumab) on RSV disease, a NACI Statement on the recommended use of Palivizumab and an updated chapter for the Canadian Immunization Guide.
RSV INESSS Literature Review For Information	The draft literature review was presented to NACI.
RSV: Burden of Disease Summary For Information	The RSV WG Chair presented the search process results for the systematic reviews on the burden of RSV disease. The validity of the screening/selection process used in the reviews be assessed in a sample of the studies.
Pneumococcal Working Group For Information	The committee received a WG update. The Statement was circulated for approval in January 2018. The feedback and comments received will be incorporated and the advance copy is planned to be released in April 2018. The proposed next WG activity is the review of the preferential NACI PNEU-C-13 recommendation. This will be shared with P/Ts for feedback. The WG also plans to review the WHO systematic review and CIQ analysis and recommendations for the PNEU-C-10/13 mixed schedule.
Adjournment	The Chair thanked members for their contributions and adjourned the meeting.

September 2017

Summary of Discussions September 27-28, 2017 Meeting, Ottawa, Ontario
Agenda Item	SUMMARY
Welcome and Introduction	The National Advisory Committee on Immunization (NACI) Chair welcomed participants to the meeting. The Chair also welcomed the four new NACI members and Secretariat staff.
Influenza Working Group (IWG): Terms of Reference Update For Information	The NACI Executive Secretary presented the Terms of Reference (TOR) of the Influenza Working Group (IWG).
IWG: General Update For Information	The IWG Chair provided an update on the working group's ongoing and upcoming work and summarized the discussion by the Advisory Committee on Immunization Practices (ACIP) IWG on a recent article published in the journal Vaccine by Donahue et al. that presented risk of miscarriage and influenza vaccine during pregnancy. The NACI IWG will review the implications of the Donahue study.
Influvac: Addendum to the Statement on Seasonal Influenza Vaccine for 2017-2018 For Information	The IWG conducted a systematic review for Influvac use in children and this review will provide supportive evidence for an addendum to the 2017-2018 influenza statement. Literature review findings and the proposed recommendation on Influvac use in children were presented.
Canadian Immunization Guide Update For Information	An update was provided by the Secretariat on the CIG chapters. There have been no new web postings since the June 2017 meeting. The NACI webpage migrated to Canada.ca on August 5, 2017.
Part 3, Working Group Update For Decision	The Working Group Chair provided an overview of the revisions for the "Immunization of Immunocompromised Persons" and "Immunization of Persons with Chronic Diseases" chapters. Further review was required and recommendations will be brought back to NACI for approval.
CIRN Update For Information	An update was provided to NACI which included background information, objectives, priorities and funding. CIRN relies on prioritization provided by PHAC, including NACI priorities and guidance from various committees.
Statement: Pertussis For Decision	The Pertussis statement was presented to the committee for conditional approval. The economic analysis was removed from this specific statement, but will be done for the overall pertussis program evaluation statement. Decision: the revised statement was approved.
CIG Chapter Revision Methodology and Publication Options For Information	Proposed options for CIG chapter revisions methodology were presented. There is currently only a basic overview online with no specific methodology. Several options were discussed, and will be further examined by the Working Group Chairs.
Evidence-based Methodology Working Group Update For Information	An overview was provided of work done and next steps, including explaining improved wording and consistency of NACI recommendations. The Management Options table tool was also presented.
Ethics, Equity, Feasibility, Acceptability (EEFA) Update For Information	The Committee was provided with information on the expansion of NACI's mandate. Programmatic factors have been coupled with scientific factors. The results of a survey on common guidance completed in spring of 2015, along with environmental scans were reported to the Committee.
Economics Task Group Update For Information	A summary of the work to date was given to the Committee, outlining the next steps.
Meningococcal Working Group Update For Decision	The WG is working on developing a NACI Statement on Tumenba for use in individuals 10-25 years of age in anticipation of the NOC for Tumenba by end of year. A summary of work was given and options were presented to the WG for feedback on economic analysis to be used for the Trumenba statement. Decision: A systematic literature review for economics will be conducted.
Vaccine Supply Update For Information	A Vaccine Supply update will now be standing item on the NACI agenda. Background information on how NACI has assisted PHAC during vaccine shortages was provided and NACI was provided with vaccine supply issues and updates.
Statement: RSV For Information	An update was provided to NACI on the status of the WG activities including: Quebec's INESSS literature review on Palivizumab; the literature review on the burden of RSV disease in children; the NACI Statement; and the RSV CIG chapter.
Measles For Information	A presentation was given on issues identified as priorities from the work plan and next steps were discussed. The WG will be reactivated to address issues that were identified as priority including: Consideration for recommending a second dose for individuals who did not get a second dose of Measles containing vaccine since they were not part of catch-up programs in 1996/97. Dose of measles Ig needed for protection post exposure (for infants under 6 months and pregnant women) The Working Group would also like to consider mumps containing vaccine during an outbreak.
Herpes Zoster Working Group Update For Decision	The Working Group Chair provided a status on status of work to date. The NACI statement is being drafted with information available; management options table outlining evidence for various options. Decision: Herpes Zoster work be prioritized over other NACI work.
Statement: Pneumococcal For Information	The statement was reviewed and some relatively small changes were suggested to the wording in various places. The statement is anticipated to be released in Spring 2018.
General Business Status Report on NACI Activities Vaccine Pipeline Submissions and Notice of Compliance NACI Work plan NACI Membership For Information	The Executive Secretary advised the committee of new developments at PHAC, NACI Membership, important dates and events, and other pertinent updates. An overview of the vaccine industry pipeline submissions was provided, highlighting additions since the June meeting.
Liaison Representative and Ex-officio Updates All For Information	Updates were provided by liaison and ex-officio representatives including the: Canadian Association for Immunization Research and Evaluation; Canadian Immunization Committee; Canadian Paediatric Society; Canadian Public Health Association; Centers for Disease Control and Prevention; Marketed Health Products; and Society of Obstetricians and Gynaecologists of Canada.

June 2017

Summary of Discussions June 7-8, 2017 Meeting, Ottawa, Ontario
Agenda Item	SUMMARY
Welcome and Introduction	The Chair welcomed participants to the meeting.
Influenza Working Group For Information	A general update was provided about completed projects, specifically the statement on Seasonal Influenza Vaccine for 2017-2018 and ongoing projects, including the statement on Seasonal Influenza Vaccine for 2018-2019 and two accompanying literature reviews. Upcoming work includes an addendum for the pediatric indication extension of an existing trivalent inactivated influenza vaccine product, Influvac^®(Mylan) that will be completed by the end of September 2017.
Literature Review on individuals with neurologic conditions and risk of serious influenza-related outcome For Information	The findings of the literature review on individuals with neurologic or neurodevelopmental conditions (NNCs) and risk of serious influenza-related outcomes was provided. It was highlighted that the literature review was conducted as a rapid review, rather than a systematic review, where concessions were made to elements of the systematic review process due to time and resource constraints and that the bulk of identified evidence was descriptive in nature.
Statement 2018-2019 Influenza Statement For Information	The evidence tables and a summary of findings regarding the literature review update on the efficacy/effectiveness evidence of Fluzone High Dose and MF59-adjuvanted Fluad vaccines in adults 65 years of age and older was presented. It was noted that the Influenza Working Group concluded that the additional studies identified from the literature review update does not change existing conclusions about the body evidence for Fluzone High Dose and Fluad.
2016-2017 End-of-season influenza VE in the prevention of hospitalization in Canadian adults: An update from the CIRN SOS Network For Information	The 2016−2017 end-of-season influenza vaccine effectiveness on the prevention of influenza-related hospitalization in Canadian adults was presented by Dr. Shelly McNeil.
Repeat Influenza Vaccination Update For Information	Repeat influenza vaccination effects were presented by Dr. Danuta Skowronski, including a review of historic and recent observations. Findings from a recent publication by Canadian investigators were also presented, interpreting repeat vaccination effects for influenza A (H3N2) in the context of the Smith et al. antigenic distance hypothesis. Other animal model findings, immunological interactions and mechanisms potentially relevant in understanding repeat influenza vaccination effects were discussed.
Sentinel Practitioner Surveillance Network: 2016-2017 Updated Influenza VE Estimates For Information	Dr. Danuta Skowronski presented on the 2016−2017 end-of-season virological and vaccine effectiveness findings from the Sentinel Practitioner Surveillance Network, including detailed genomic characterization of dominant influenza A (H3N2) epidemic viruses. VE findings were also explored by province, clade and prior vaccination history. Potential relevance of findings for the upcoming season's unchanged A(H3N2) vaccine component were highlighted.
Statement: Pertussis For Information	The Working Group Chair presented on the status of the Pertussis statement including key issues for considerations. Results of the evidence review and draft recommendations were presented. The proposed approach was to publish a separate literature review to keep the statement more streamlined as it would only include a summary of the evidence reviewed. A budget impact assessment was included in the draft statement; vaccine and administration costs based on pregnancy rates and coverage estimates. The WG did not consider that a budget impact assessment was a useful approach.
NACI Research Priorities for the CIHR Best Brain Exchange (BBE) Update For Information	Dr. Christina Bancej presented on the PHAC-HC Best Brains Exchange (BBE) that was held on February 24, 2017 entitled "An integrated approach for monitoring influenza vaccine effectiveness to inform public health policy and influenza immunization program implementation in Canada". Forty experts were on hand at the BBE meeting to discuss influenza vaccine effectiveness (I-VE). Key messages to emerge from the BBE include the requirement of sustained funding and the importance of transparent communication about vaccine effectiveness (VE) and vaccine safety. There were two discussions; one based on policy and program needs and the other focussed on approaches and methodology. There was a lack of consensus on optimal data sources.
Canadian Immunization Guide Update For Information	An overview was provided on the progress made on the CIG since the February 2017 meeting. PHAC is now caught up on the back log of CIG chapters.
Vaccine Administration Practices Chapter revision For Decision	The CIG Part 1 working group chair provided an overview of the Vaccine Administration Practices Chapter revisions; which included the presentation of proposed changes in recommendation. Decision: NACI approved the revised recommendations.
Revised Immunization of Immunocompromised Persons Chapter For Information	The working group chair provided an overview of the process to date on the reviewing and revising of both the Immunization of Immunocompromised Persons chapter and the Immunization of Persons with Chronic Diseases chapter. Many changes were made in text structure to clarify statements or to improve flow, however only major changes were presented for discussion. Questions specific to certain NACI Working Groups have arisen from the review of these chapters and were presented.
Vaccine Safety working Group Update For Information	The working group chair provided an overview of working group activities and next steps.
Moving from evidence to recommendations: the experience of the Strategic Advisory Group of Experts on Immunization (SAGE) in using evidence-to-recommendation tables For Information	Dr. Philippe Duclos, Executive Secretariat, SAGE, presented to NACI on the use of evidence to recommendations tables as part of the operating processes of the Strategic Advisory Group of Experts on Immunization (SAGE) which is the principal advisory group to WHO for vaccines and immunization. It briefly alluded to the main SAGE operating processes, but mainly focused on the evidence-based review that SAGE does to move from evidence to recommendations, alluding to the use of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) and then reviewing in detail the rational for the use of evidence to recommendations tables, their structure and criteria used, and the experience and challenges in the use of the tables. The completion of the tables was illustrated using the example of the dengue vaccine.
Evidence-based Methodology Update For Information	The working group chair provided an overview of the working group activities as well as a refresher on what was presented at the February 2017 NACI meeting.. A summary of the work completed to date and the status of the shorter term and longer term next steps in the context of Common Guidance was also provided to the Committee. Work is currently underway for the economics as well as the ethics, equity, feasibility and acceptability frameworks.
NACI Use of External Literature Review (Algorithm) For Decision	A proposed process for decision-making when considering the use of an external literature review in NACI statements was presented. Decision Point brought to NACI was whether NACI agrees that the EBM WG pilot-test the decision algorithm and use of AMSTAR with upcoming VPD WGs. Decision: NACI approved the tool for piloting.
Herpes Zoster Update For Information	The Working Group Chair provided an update on the status of work completed and next steps.
Liaison Representative /Ex-Officio Updates For Information	Updates were provided by liaison and ex-officio representatives including the: Association of Medical Microbiology and Infectious Disease Canada; Canadian Association for Immunization Research and Evaluation; Canadian Immunization Committee; Canadian Paediatrics Society; Canadian Immunization Committee; Council of Chief Medical Officers of Health; First Nations and Inuit Health Branch, Health Canada; Marketed Health Products Directorate, Health Canada; and Society of Obstetricians and Gynaecologists of Canada.
RSV Working Group Update For Information	An update on the status of the work of the RSV working group was delivered to the Committee. There is a need to update the recommendations on the use of monoclonal antibody (palivizumab) for reducing the complications of RSV infection in children as the current NACI recommendations are outdated (2003). An update on the status of the updated INESSS literature review on the effects of anti-RSV antibody on reducing the complications of RSV infection in children and the RSV burden of disease literature review were provided.
General Business Status Report on NACI Activities Vaccine Pipeline Submissions and Notice of Compliance NACI Work plan For Information	The NACI Executive Secretary gave a brief overview of NACI activities in progress, including expected timelines. An overview of the vaccine industry pipeline submissions was provided, highlighting additions since the June meeting.
Adjournment	The Chair thanked members for their contributions and adjourned the meeting.

February 2017

Summary of Discussions February 8-9, 2017 Meeting, Ottawa, Ontario
Agenda Item	SUMMARY
Welcome and Introduction	The Chair welcomed participants to the meeting.
GSK Candidate Herpes Zoster Subunit Vaccine (HZ/su) For Information	A presentation was provided by GSK on Efficacy, Safety and Immunogenicity of GSK's Candidate Herpes Zoster Vaccine, including co-administration with IIV4, as well as alternate dosing schedules.
Herpes Zoster Working Group Update For Information	An overview of Zostavax^®(Merck Frosst: live-attenuated vaccine) and NACI's recommendations from past statements, the candidate HZ/su vaccine (GSK), and the network meta-analysis being completed by Drug Safety and Effectiveness Network (DSEN), which was established by the Canadian Institutes of Health Research (CIHR), was provided to the committee. The Herpes Zoster Working Group will consider the timing for administration of this vaccine after an individual has been infected.
Evidence-Based Methodology Working Group Update For Decision	The Working Group Chair provided an update on the WG's activities and next steps. The objectives for the presentation were: approval of the wording for NACI's recommendations; review of revised algorithm for publications that are not peer-reviewed, further to the NACI discussion in October 2016; and WG workplan and next steps. The proposed wording for recommendations was presented for review and approval and the Committee agreed to keep the labels for strength of recommendation. Decision: NACI approved the use the term "discretionary".
Pfizer Meningococcal B Vaccine For Information	A presentation was provided by Pfizer regarding the approach to vaccine development and vaccine composition, coverage and selection of clinical testing strains, approach to demonstration of breadth of coverage, overview of clinical data, long-term immunogenicity and response to the booster dose and ongoing and future research.
Meningococcal Working Group Update For Information	The Working Group Chair presented an overview of priorities and a summary of work done to date. The highest priority item is a statement on Meningococcal serogroup B, reviewing the forthcoming Trumenba vaccine (NOC expected later this year) and new data on Bexsero^®. Next steps include the presentation of epidemiologic data from Canada and the UK at NACI's June meeting and a draft summary of the statement at the September meeting.
General Business Status Report on NACI Activities Vaccine Pipeline Submissions and Notice of Compliance NACI Work plan For Information	The NACI Executive Secretary gave a brief overview of NACI activities in progress, including expected timelines. An overview of the vaccine industry pipeline submissions was provided, highlighting additions since the October 2016 meeting.
Liaison Representative /Ex-Officio Updates For Information	Updates were provided by liaison and ex-officio representatives including the: Association of Medical Microbiology and Infectious Disease Canada; Biologics and Genetics Therapies Directorate, Health Canada; Canadian Association for Immunization Research and Evaluation; Canadian Immunization Committee; Canadian Paediatrics Society; Canadian Public Health Association; Centers for Disease Control and Prevention; First Nations and Inuit Health Branch, Health Canada; Marketed Health Products Directorate, Health Canada; Society of Obstetricians and Gynaecologists of Canada; and Vaccine Safety Working Group, Public Health Agency of Canada.
Influenza Working Group (IWG) General Update: Summary of ongoing monitoring activities For Information	The Working Group Chair presented a general update on ongoing activities. The IWG is continuing to monitor evidence on the potential effects of repeat influenza vaccination. Two externally conducted systematic reviews regarding the effects of repeat influenza vaccination are anticipated to be available for IWG review in the near future. The IWG will also continue to monitor vaccine effectiveness data for the live-attenuated influenza vaccine. The draft IWG work plan for the 2017-2018 fiscal year was reviewed. The Statement on Seasonal Influenza for 2017-2018 (the Statement) will be web posted in May 2017. Publication will coincide with the publication of two articles in the Canada Communicable Diseases Report (CCDR) summarizing the Statement and the evidence used to develop the addendums to the 2016-2017 Statement on use of the live-attenuated influenza vaccine. The development of 2018-2019 Statement is underway. Timelines and next steps for the statement and the review on neurologic and neurodevelopmental conditions were reviewed.
NACI Research Priorities for the CIHR Best Brains Exchange (BBE) For Information	A presentation was made to NACI to solicit input for the BBE meeting scheduled for February 24, 2017. The NACI Chair was invited to present on behalf of NACI. The presentation to NACI included input from the IWG gathered during their last meeting on data needs for vaccine effectiveness monitoring. A report back on the BBE will be provided to NACI at the June 2017 meeting.
Vaccine Safety Working Group (VS-WG) Update For Information	The Working Group Chair provided an update on the working group's activities and an overview of the Working Group's TOR changes.
Canadian Immunization Guide (CIG) For Information	An update on recent changes to the CIG was provided. Active CIG Working Groups include: Part 1, Key Immunization Information Working Group is reviewing the Vaccine Administration Practices chapter Part 2, Vaccine Safety Working Group is initiating review of all chapters in this section. Part 3, Immunization of Specific Populations Working Group is reviewing the Immunization of Immunocompromised Persons Chapter
RSV Working Group Update: Proposed 2017-2018 Work Plan For Information	The Working Group Chair provided an update on activities. The Working Group will be developing three products: a literature review, statement and a new RSV chapter for the Canadian Immunization Guide. The primary objective of the Working Group is to update the 2003 NACI statement as it is still being used. Additional proposed content includes economic information (not a modelling study) and an overview of vaccines in development. A vaccine is expected in approximately 4-5 years. Vaccine development pipelines include candidates for older adults, pregnant women and infants. Vaccine candidates for older adults are the closest to submission. When a vaccine is approaching submission, the epidemiology of infection in adults will need to be assessed.
Pneumococcal Working Group Update and presentation on Exploring the Acceptability of the Available Pneumococcal Conjugate Vaccines in Canadian Health Care Professionals and Immunization Experts For Decision	The Working Group Chair provided an update on work to date and timelines. There are some outstanding issues, such as how to move forward with the integration of the economic evaluation into the current statement. A draft statement is expected to be presented at the NACI meeting in June 2017. McGill University presented the project "Exploring the Acceptability of the Available Pneumococcal Conjugate Vaccines in Canadian Healthcare Professionals and Immunization Experts". This project was initiated as a result of the Health Canada authorization of PCV10 cross protection for 19A. The committee discussed whether it should embark on a new PCV-10 vs PCV13 statement. Decision: NACI agreed that the PCV10 and PCV 13 recommendations question would be retained on the NACI workplan as a low priority.
Pertussis Working Group Update For information	The Working Group Chair provided an update on activities and next steps. Phase 1 of the work plan is looking at maternal immunization, Phase 2 will be looking at the 2+1 schedule for the hexavalent product and Phase 3 will be looking at adolescents and adults.
HPV Working Group Update For information	The Working Group Chair provided an update on activities and next steps. The work plan currently includes a review of evidence on vaccination of high risk groups and the prevention of other HPV-related cancers. Work completed to date include: 9vHPV statement (web-published in July 2016); 2-dose statement and literature review on immunocompromised persons (pre-released in November 2016 and the advance copy was issued on December 21, 2016).
Adjournment	The Chair thanked members for their contributions and adjourned the meeting.

October 2016

Summary of Discussions October 5-6, 2016 Meeting, Ottawa, Ontario
Agenda Item	Summary
Welcome and Introduction	The Chair welcomed participants to the meeting.
Evidence-based Methodology (EBM) Working Group Update	An update was provided on the work done to date and to discuss the role and activities of the Working Group in the context of the expanded mandate for NACI. The short-term and long-term next steps for the Working Group were presented and discussed. A proposal for revised wording for NACI recommendations was presented for discussion, as well as an algorithm developed to provide transparent and logical steps for NACI to consider when deciding to develop guidance in the absence of published peer-reviewed literature. The Working Group will provide an oversight function for the development of processes and methods for the additional elements of NACI's expanded mandate.
Common Guidance Update - Expanded NACI Mandate	An update on the implementation and pilot projects for NACI's expanded mandate was presented. Pilot projects will be initiated over the next year to assist in the development of new processes and methods for the implementation of the expanded NACI mandate. A session will be presented at the upcoming Canadian Immunization Conference on what is new with NACI including the implementation of the expanded mandate.
Working Group Update: Hepatitis B	The Working Group Chair provided a summary of work done to date and the changes made to the Hepatitis B Statement Update since NACI's first review in August 2016. The statement and recommendations were approved by NACI.
Working Group Update: HPV	The Working Group Chair provided an update on the work done to date. Pre-release of the current statement on a two dose schedule for the HPV nine-valent vaccine is expected in November.
Working Group Update: Pertussis	The Working Group Chair presented the project plan and timelines for a 3-phased approach. The WG will begin in Phase 1 with a review of the evidence and recommendations for Tdap immunization in pregnancy to prevent pertussis infection in infants. The project plan was reviewed by the Canadian Immunization Committee prior to presentation to NACI. Phase 2 and 3, immunization in children, adolescents and adults will be defined following Phase 1.
Working Group Update: Meningococcal	The Working Group Chair provided an update on the upcoming priority items to be addressed by the Working Group. The Working Group will be focussing its current activities on Meningococcal B vaccine recommendations.
Working Group Update: Influenza	The Working Group Chair provided a summary of recent web publications, including the two addendums to the 2016-2017 Statement on Seasonal Influenza Vaccine; LAIV use in Egg-Allergic Individuals, and LAIV Use in Children and Adolescents.
Survey Results: Seasonal Influenza Statement New Format	Highlights of the results of the recent online stakeholder survey on the new format of the Statement on Seasonal Influenza Vaccine were provided. In general, respondents were satisfied with the new format. Some suggestions for improvement were provided and will be taken into consideration by the Working Group.
Literature Review: Individuals with Neurological Conditions	The Working Group Chair provided a summary of the work completed to date and reviewed next steps and timelines for the Working Group. The Working Group will add this item to their work plan; timeline to be determined.
Tutorial Session: Primer on Health Economic Evaluations	A presentation was provided on economic evaluations, which included an overview of the type and components of economic evaluations and how conclusions can be drawn from economic models.
Working Group Update: Pneumococcal	The Working Group Chair provided a summary of the work completed to date and reviewed next steps and timelines for the Working Group. The Working Group is continuing to develop the statement on pneumococcal vaccination in immunocompetent adults 65 years of age and older (population level), in follow-up to the interim statement, which is expected to be published online later in October.
Liaison Representative /Ex-Officio Updates	Updates were provided by liaison and ex-officio representatives including the: Association of Medical Microbiology and Infectious Disease Canada; Biologics and Genetics Therapies Directorate, Health Canada; Canadian Association for Immunization Research and Evaluation; Canadian Paediatrics Society; Canadian Immunization Committee; Canadian Public Health Association; Centers for Disease Control and Prevention; Canadian Immunization Research Network; First Nations and Inuit Health Branch, Health Canada; Marketed Health Products Directorate, Health Canada; and National Defense and the Canadian Armed Forces.
Canadian Immunization Guide (CIG) Update	An update on recent updates to the Canadian Immunization Guide (CIG) was provided. The migration of the CIG to the new Canada.ca web platform is complete. The new platform offers additional features including the ability to view and search entire Parts of the CIG. Following completion of the migration, the plan moving forward is for CIG chapters to be updated on the same day that a Statement is published.
Roles and Responsibilities for NACI members and NACI Secretariat	The NACI Executive Secretary highlighted some elements of the draft roles and responsibilities of the NACI Secretariat as a companion document to the NACI member and liaison and ex-officio representative roles and responsibilities. These documents were developed for internal operational purposes.
Working Group Update: Vaccine Safety	An update on the status of the Vaccine Safety Working Group was presented. The Working Group will be revising its terms of reference and bringing them to NACI for approval. The Working Group will also be initiating the review of the safety section of the CIG and developing an engagement approach with other NACI working groups.
General Business Status Report on NACI Activities Vaccine Pipeline Submissions and Notice of Compliance NACI Work plan	The NACI Executive Secretary gave a brief overview of NACI activities in progress, including expected timelines. An overview of the vaccine industry pipeline submissions was provided, highlighting additions since the June meeting.
Adjournment	The Chair thanked members for their contributions and adjourned the meeting.

June 2016

Summary of Discussion June 8-9, 2016 Meeting, Ottawa, Ontario
Agenda Item	Summary
Welcome and Introduction	The Chair welcomed participants to the meeting.
Launch of Common Vaccine Guidance	An expansion in NACI's mandate was launched to achieve integrated common vaccine guidance. Through the expanded mandate programmatic elements will be added to the assessment completed by NACI to formulate it's recommendations, including economic evaluation, and feasibility, acceptability, ethics and equity assessments. The expanded mandate will be implemented over the next few years as methods and processes are developed. The implementation will be informed by several pilots planned for the coming year.
Canadian Immunization Research Network (CIRN) Update	An update was provided to NACI on the current research activities of CIRN. The presentation included an overview of network objectives, areas of research interest, network structure and capacity, and completed projects.
NACI Research Priorities	Following CIRN's presentation, NACI discussed committee identified research gaps from previous NACI products and recently requested information from Working Group Chairs.
Canadian Immunization Guide (CIG) Update	A status update of chapter reviews and revisions was presented to NACI. The review cycle, with each chapter being reviewed at a minimum of every four years, is on track. Working groups have been established for Part 1 and 3 and they are actively reviewing chapters for updates and presentation to NACI as required.
Biologics during pregnancy and immunization	An update to the CIG chapter, Immunization of Immunocompromised Persons, was presented for approval following discussion at the two previous NACI meetings. The updated text on the immunization of infants exposed to monoclonal antibodies in utero was approved by NACI. This update will be applied to the chapter posted online.
Canadian Association for Immunization Research and Evaluation (CAIRE) 2.0 - Life After the Scheifele Era	CAIRE is in the process of evaluating its role in the current Canadian context. NACI members were asked for advice and feedback regarding CAIRE's role in the increasingly complex Canadian vaccine environment.
Statement: Update Recommendations on Human Papillomavirus (HPV) Vaccines: 9-valent HPV vaccine 2-dose immunization schedule and the use of HPV vaccines in immunocompromised populations	The working group chair presented the draft statement and recommendations for NACI review and discussion. The recommendations for immunocompromised populations are supported by a literature review that will be published as a separate document. Final approval will be sought from NACI following the meeting.
Pertussis Working Group Update	The working group chair provided an update on activities and confirmed next steps with NACI. The project plan and research questions for the literature reviews were presented to NACI and approved. The project plan will be presented to the Canadian Immunization Committee for comment prior to implementation of the plan.
Hepatitis B Working Group Update	The working group chair provided an update on working group activities and work done to date. The working group is expecting to have the draft statement ready for NACI review by the fall.
Evidence-Based Methodology Working Group Update	An overview of the work done to date was provided as well as an update on next steps and short term and long term activities. There has been no working group engagement since the fall of 2015. NACI agreed with the proposed approach. Working group meetings will be resumed.
Roles and Responsibilities of NACI Members, Liaison Representatives and Ex-officio Representatives	As per the October 2015 NACI meeting, a draft document outlining roles and responsibilities of NACI members, liaison representatives and ex-officio representatives has been prepared. The document will be finalized following the meeting and additional comments from members and will be used for internal NACI operational purposes.
NACI Statement on Seasonal Influenza Vaccine for 2017-2018	The working group chair presented the changes made to the statement from the 2016-2017 statement. NACI approved the statement. The statement will be disseminated to provincial and territorial governments this fall and will be posted online in the spring of 2017.
Influenza Working Group Update	An update was provided on the survey developed to evaluate the combined statement format, which was implemented in 2015-2016. The survey was posted with the 2016-2017 statement and will be active for several months. NACI agreed that the literature review for influenza vaccination in adults with neurological conditions should be revisited by the working group when resources become available.
Influenza Repeat Vaccinations (I-ReV) effects: Emerging evidence, trends and perspectives	Dr. Danuta Skowronski presented emerging evidence, trends and perspectives on the negative effects of prior vaccination on current influenza vaccine protection. This presentation has been previously presented to the Influenza Working Group. Studies from Canada, the United States and Europe have reported negative effects of prior vaccination on current influenza vaccine effectiveness, including a negative dose response effect with additional doses received.
Impact of prior season vaccination on influenza vaccine effectiveness (VE) in four consecutive seasons (2011-2012 through 2014-2015) and in-camera discussion without the presenters	Dr. Shelly McNeil presented findings on the impact of prior season vaccination on subsequent influenza VE in four consecutive seasons from the Canadian Immunization Research Network (CIRN) Severe Outcome Surveillance (SOS) Network. There was varied impact of prior vaccination on subsequent VE observed from season to season among hospitalized patients. The impact of prior vaccination was larger in some seasons (e.g., 2012-2013 and 2014-2015) than others. It was noted that unmeasured indication bias may have accounted for the observed impact and further study is needed.
Economic Analysis of Pneumococcal Vaccination for Elderly Adults in Canada	A revised presentation was provided as an adjustment was made to model estimates from the presentation provided at the NACI February meeting. The model evaluated the cost-effectiveness of different pneumococcal vaccination strategies: Pneumococcal Polysaccharide 23-valent vaccine (PPV23) at age 65 years, Pneumococcal Conjugate 13-valent vaccine (PCV13) at age 65 years, PPV23 at age 65 years, PCV13 one year later as well as PPV23 at age 65 years and 70 years.
Pneumococcal Working Group Update	The working group chair provided an update on working group activities and discussed next steps. A draft statement incorporating the systematic review presented at a previous meeting and results from the economic analysis will be prepared for NACI review. This will be an early pilot of the incorporation of additional elements into NACI processes and products as per its expanded mandate announced earlier in the meeting.
Liaison and Ex-Officio Representative Updates	Updates were provided by liaison and ex-officio representatives including the: Association of Medical Microbiology and Infectious Disease Canada; Biologics and Genetics Therapies Directorate, Health Canada; Canadian Association for Immunization Research and Evaluation; Canadian Paediatrics Society; Canadian Immunization Committee; Canadian Public Health Association; Centers for Disease Control and Prevention; Committee to Advise on Tropical Medicine and Travel; Marketed Health Products Directorate, Health Canada; and Vaccine Safety Section, Public Health Agency of Canada.
National Immunization Technical Advisory Group (NITAG) International Network meeting update	An update was provided on the NITAG International Network meeting that took place in May. The meeting marked the launch of the international NITAG network. General network principles as well as secretariat and other functions were discussed. A meeting report is planned for public release.
General Business Status Report on NACI Activities Vaccine Pipeline Submissions and Notice of Compliance NACI Work plan	A brief overview was presented on NACI activities in progress, including expected timelines. An overview of the vaccine industry pipeline submission template was also provided, highlighting additions since the February meeting.
Pipeline Day - April 13, 2016	NACI members were informed that the Canadian Immunization Committee discussed the pipeline day at their recent face-to-face meeting. NACI members were asked for additional feedback on the pipeline day.
Adjournment	The Chair thanked members for their contributions and adjourned the meeting.

February 2016

Summary of Discussion February 10-11, 2016 Meeting, Ottawa, Ontario
Agenda Item	Summary
Welcome and Introduction	The Chair welcomed participants to the meeting.
Economic Evaluation of Vaccination Against Pneumococcal Disease in Elderly Adults in Canada	An evaluation of the cost effectiveness of different vaccination strategies with PPV23 and PCV13 for elderly adults in Canada was presented. The presenter is planning to release the model and results publicly later this year and publish in a peer-reviewed journal pending acceptance.
Statement: Update of PNEU-C-13 Use in Otherwise Healthy Adults - Individual Recommendation	The working group chair provided a status update on the statement. It has been reviewed by the Canadian Immunization Committee and approved by NACI. Next step will be the pre-release, following the Public Health Agency of Canada's (PHAC) approval. The working group will then focus on the preparation of a new statement on recommendations at a population level with a focus on public health impacts and benefits. The statement will be informed by literature reviews on PCV13 and PPV23. The timelines of the draft population level statement have not been determined at this time.
Systematic Review - Vaccine Effectiveness PPV23	The results of a systematic review and meta-analyses were presented on the vaccine effectiveness of PPV23 in the prevention of invasive pneumococcal disease (IPD) and community acquired pneumonia (CAP) among the general population 50+ years of age. The systematic review synthesizes and appraises the published literature in a population comparable to a recent trial of PCV13, Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), to enable comparisons of the effectiveness of the two pneumococcal vaccines. The methods, results, limitations, and conclusions were outlined. The review included 31 studies. Overall, 5 meta-analyses were performed and funnel plots were included to assess publication bias. The results were stratified according to several different factors, such as method and time since diagnosis.
Statement: HPV Update	The HPV working group chair provided NACI with an update on working group activities. The statement on HPV9 3-dose schedule and minimum intervals will be ready for pre-release following the meeting. The working group has also completed a literature review on HPV vaccination in immunocompromised populations, which was presented. The working group also discussed 2-dose recommendations for HPV9.
Literature Review: HPV Immunization of Immunocompromised Populations	The methodology and results of a literature review on HPV vaccine use in immunocompromised populations was presented. A scan of recommendations from other National Immunization Technical Advisory Groups (NITAGs) was also completed. The literature review will be used by the HPV Working Group to support the development of a new statement.
Comparison of immunogenicity of 2-dose and 3-dose regimens of 9-valent HPV vaccine	A presentation was provided to NACI by Merck Canada on the clinical study Protocol V503-010 that was conducted to compare the immunogenicity of 2 doses of 9-valent HPV vaccine administered at a 6- or 12-month interval in girls and boys 9-14 years of age versus 3 doses administered at 0, 2, and 6 months in women 16-26 years of age (i.e., the dose regimen and population used to establish vaccine efficacy). The study demonstrated non-inferior HPV antibody responses in girls and boys who received 2 doses compared with women who received 3 doses. Based on these results, and using the same approach that was previously accepted for licensure of 2-dose and 3-dose regimens of the quadrivalent HPV vaccine and the 3-dose regimen of the 9-valent HPV vaccine in girls and boys, efficacy findings in women who received 3 doses can be extended to girls and boys who received 2 doses of the vaccine.
Statement: HPV 2-dose and immunocompromised draft recommendations	The working group chair presented draft recommendations for immunocompromised populations. NACI agreed in principle with the recommendations included in the statement. NACI's approval was also requested for an amendment to the February 2015 HPV 2-dose statement for quadrivalent and bivalent formulations; revising the recommendations on minimum intervals and aligning the statement with the current HPV statement update being prepared for release. The statement update will also include recommendations on a 2-dose schedule for the 9-valent HPV vaccine. The timelines for the statement will be determined following additional follow-up with the working group.
Statement: Canadian Immunization Guide Chapter on Influenza and Interim Statement on Seasonal Influenza Vaccine for 2017-18	The working group chair presented an outline for today's meeting, introducing the objectives and upcoming presentations.
A quality assessment of the systematic literature review on adults with neurological conditions and influenza immunization	A draft systematic literature review relating to adults with neurological conditions and influenza immunization presented in October was assessed. Following the presentation of the assessment, NACI agreed that the review should be repeated to confirm results.
Influenza Working Group Work plan and revised Terms of Reference	The Influenza Working Group (IWG) work plan was presented for NACI's approval. Proposed revisions to the IWG Terms of Reference were also presented for NACI approval.
Influenza Working Group Update	The Influenza Working Group (IWG) Chair gave an update on the status of the 2016-2017 statement. A brief overview was presented on revisions being considered for the 2017-2018 statement. NACI's approval on the 2017-2018 statement will be sought at the June 2016 meeting. The Chair also updated the group on an evaluation of the new format for the combined seasonal influenza statement and Canadian Immunization Guide chapter that is being planned. The survey will be available concurrently with the publication of the 2016-2017 statement.
Canadian Immunization Guide (CIG) Chapter Approval Process	An update was provided on the recently developed levels of approval required for changes to the Canadian Immunization Guide (CIG). The level of approval is based on the nature of the changes being proposed. NACI agreed to the proposed approval process.
CIG Part 5: Passive Immunizing Agent	A proposal for the removal of Part 5 was presented to NACI. NACI agreed with the removal of Part 5 with additional mapping of content in consultation with leads for CIG chapters where Part 5 content will be relocated. A chapter on Respiratory Syncytial Virus (RSV) is to be created and added to Part 4 of the Guide.
BCG Chapter Update	NACI agreed that the BCG chapter is an important component of the CIG. When the chapter is reviewed contact should be made with the leads for the Canadian Tuberculosis Standards to discuss potential collaboration and information sharing.
National Immunization Strategy	An update was provided on the review of the National Immunization Strategy being conducted through the Public Health Network.
Common Guidance	Internal PHAC briefings and approvals are underway on a Common Guidance model through an expanded mandate for NACI, incorporating additional elements into the activities of the committee including economic evaluations.
Liaison Representatives/Ex-Officio and other Updates	Updates were provided by liaison and ex-officio representatives including the: Association of Medical Microbiology and Infectious Disease Canada; Biologics and Genetics Therapies Directorate, Health Canada; Canadian Paediatrics Society; Canadian Immunization Committee; Canadian Immunization Research Networks; Canadian Public Health Association; Society of Obstetricians and Gynaecologists of Canada; Canadian Association for Immunization Research and Evaluation; Centers for Disease Control and Prevention; Canadian Paediatrics Society; First Nations and Inuit Health Branch, Health Canada; and Marketed Health Products Directorate, Health Canada.
Live Vaccines: Biologics & Pregnancy	The methods and results of a recent publication on the use of vaccines for infants exposed to biologicals in utero were presented. The current evidence on this topic is limited and is based to a large extent on case reports.
CIG Immunization of Immunocompromised Persons chapter - Monoclonal Antibodies	During the October 2015 NACI meeting, it was decided to remove breastfeeding as a contraindication and precaution to immunizing infants of mothers receiving monoclonal antibodies. Evidence and proposed CIG text for vaccination of infants born to mothers who received monoclonal antibodies in pregnancy was discussed. Revised text is to be brought back to NACI for further consideration.
General Business Status Report on NACI Activities Vaccine Pipeline Submissions and Notice of Compliance NACI Work plan	The NACI Executive Secretary gave a brief overview of NACI's business and activities in progress, including expected timelines. An overview of vaccine industry pipeline submissions was provided, highlighting additions since the October meeting. A vaccine pipeline day pilot meeting is being considered for spring 2016.
Working Group Vice-Chairs	Currently none of the working groups have designated vice-chairs. The potential role and need for a working vice-chair were discussed. The appointment of a working group vice-chair will be left to the discretion of the working group chair. The vice-chair can be a NACI voting member of liaison representative.
Vaccine Safety Working Group Update	A general working group update was provided. Additional discussion is required on the role and functioning of the working group.
Statement: Measles	An update was provided on working group's activities. As previously presented, topics for WG review include: Optimal timing of doses, the administration of MMR(V) following receipt of blood products and natural infection, and post-exposure prophylaxis (PEP).
Members role and responsibilities on a working group for the development of NACI statement and a chapter	As per the discussion at the October 2015 meeting, the Executive Secretary presented a draft template for roles and responsibilities of NACI members, liaison and ex-officio representatives and the PHAC secretariat. The completed draft template will be brought back to NACI for review at an upcoming meeting.
Adjournment	The Chair thanked members for their contributions and the meeting was adjourned.

October 2015

Summary of Discussion October 5-6, 2015 Meeting, Ottawa, Ontario
Agenda Item	Summary
Welcome and Introduction	The Chair welcomed participants to the meeting.
Evidence-based Methodology (EBM) Working Group Update	An update was provided on the work done to date and to discuss the role and activities of the Working Group in the context of the expanded mandate for NACI. The short-term and long-term next steps for the Working Group were presented and discussed. A proposal for revised wording for NACI recommendations was presented for discussion, as well as an algorithm developed to provide transparent and logical steps for NACI to consider when deciding to develop guidance in the absence of published peer-reviewed literature. The Working Group will provide an oversight function for the development of processes and methods for the additional elements of NACI's expanded mandate.
Common Guidance Update - Expanded NACI Mandate	An update on the implementation and pilot projects for NACI's expanded mandate was presented. Pilot projects will be initiated over the next year to assist in the development of new processes and methods for the implementation of the expanded NACI mandate. A session will be presented at the upcoming Canadian Immunization Conference on what is new with NACI including the implementation of the expanded mandate.
Working Group Update: Hepatitis B	The Working Group Chair provided a summary of work done to date and the changes made to the Hepatitis B Statement Update since NACI's first review in August 2016. The statement and recommendations were approved by NACI.
Working Group Update: HPV	The Working Group Chair provided an update on the work done to date. Pre-release of the current statement on a two dose schedule for the HPV nine-valent vaccine is expected in November.
Working Group Update: Pertussis	The Working Group Chair presented the project plan and timelines for a 3-phased approach. The WG will begin in Phase 1 with a review of the evidence and recommendations for Tdap immunization in pregnancy to prevent pertussis infection in infants. The project plan was reviewed by the Canadian Immunization Committee prior to presentation to NACI. Phase 2 and 3, immunization in children, adolescents and adults will be defined following Phase 1.
Working Group Update: Meningococcal	The Working Group Chair provided an update on the upcoming priority items to be addressed by the Working Group. The Working Group will be focussing its current activities on Meningococcal B vaccine recommendations.
Working Group Update: Influenza	The Working Group Chair provided a summary of recent web publications, including the two addendums to the 2016-2017 Statement on Seasonal Influenza Vaccine; LAIV use in Egg-Allergic Individuals, and LAIV Use in Children and Adolescents.
Survey Results: Seasonal Influenza Statement New Format	Highlights of the results of the recent online stakeholder survey on the new format of the Statement on Seasonal Influenza Vaccine were provided. In general, respondents were satisfied with the new format. Some suggestions for improvement were provided and will be taken into consideration by the Working Group.
Literature Review: Individuals with Neurological Conditions	The Working Group Chair provided a summary of the work completed to date and reviewed next steps and timelines for the Working Group. The Working Group will add this item to their work plan; timeline to be determined.
Tutorial Session: Primer on Health Economic Evaluations	A presentation was provided on economic evaluations, which included an overview of the type and components of economic evaluations and how conclusions can be drawn from economic models.
Working Group Update: Pneumococcal	The Working Group Chair provided a summary of the work completed to date and reviewed next steps and timelines for the Working Group. The Working Group is continuing to develop the statement on pneumococcal vaccination in immunocompetent adults 65 years of age and older (population level), in follow-up to the interim statement, which is expected to be published online later in October.
Liaison Representative /Ex-Officio Updates	Updates were provided by liaison and ex-officio representatives including the: Association of Medical Microbiology and Infectious Disease Canada; Biologics and Genetics Therapies Directorate, Health Canada; Canadian Association for Immunization Research and Evaluation; Canadian Paediatrics Society; Canadian Immunization Committee; Canadian Public Health Association; Centers for Disease Control and Prevention; Canadian Immunization Research Network; First Nations and Inuit Health Branch, Health Canada; Marketed Health Products Directorate, Health Canada; and National Defense and the Canadian Armed Forces.
Canadian Immunization Guide (CIG) Update	An update on recent updates to the Canadian Immunization Guide (CIG) was provided. The migration of the CIG to the new Canada.ca web platform is complete. The new platform offers additional features including the ability to view and search entire Parts of the CIG. Following completion of the migration, the plan moving forward is for CIG chapters to be updated on the same day that a Statement is published.
Roles and Responsibilities for NACI members and NACI Secretariat	The NACI Executive Secretary highlighted some elements of the draft roles and responsibilities of the NACI Secretariat as a companion document to the NACI member and liaison and ex-officio representative roles and responsibilities. These documents were developed for internal operational purposes.
Working Group Update: Vaccine Safety	An update on the status of the Vaccine Safety Working Group was presented. The Working Group will be revising its terms of reference and bringing them to NACI for approval. The Working Group will also be initiating the review of the safety section of the CIG and developing an engagement approach with other NACI working groups.
General Business Status Report on NACI Activities Vaccine Pipeline Submissions and Notice of Compliance NACI Work plan	The NACI Executive Secretary gave a brief overview of NACI activities in progress, including expected timelines. An overview of the vaccine industry pipeline submissions was provided, highlighting additions since the June meeting.
Adjournment	The Chair thanked members for their contributions and adjourned the meeting.

June 2015

Summary of Discussion June 10-11, 2015 Meeting, Ottawa, Ontario
Agenda Item	Summary
Welcome and Introduction	The Chair, Dr. Ian Gemmill, welcomed participants to the meeting. The Chair acknowledged that this will be the last meeting for NACI members Dr. Blair Seifert and Dr. Deepali Kumar and ex-officio representative for the Agency, Dr. Barbara Law. Their dedication and commitment to the field of immunization and their work on NACI was acknowledged. Members were informed that the NACI Chair, Vice-Chair and Executive Secretary are in the process of assessing the applicants who put their names forward in the call for membership that was completed in May 2015. The Executive Secretary, Robert Lerch informed the committee of changes within the Agency's senior management, as well as changes within the Centre for Immunization and Respiratory Diseases. Dr. Theresa Tam has taken on the role of Assistant Deputy Minister of the Infectious Disease Prevention and Control Branch and Rhonda Kropp has taken on the role of Director General of Centre for Immunization and Respiratory Diseases. Dr. John Spika will be taking on the role of Senior Medical Advisor for the Infectious Disease Prevention and Control Branch.
HPV Working Group Updated Recommendations on Human Papillomavirus (HPV) Vaccines: 9-valent vaccine and clarification of minimal intervals between doses in the HPV immunization schedule	Dr. Shelley Deeks, Chair of the HPV Working Group provided an update on the activities of the Working Group. The analysis of HPV immunization of immunocompromised populations has been postponed to focus on the 9-valent statement. The 9-valent statement and recommendations were reviewed by NACI. The statement also includes recommendations on the minimum intervals between doses. This was the first review of the statement and recommendations by NACI.
Measles, Mumps and Rubella Working Group (MMR-WG) Update	Dr. Marina Salvadori, Chair of the MMR-WG provided an overview of the key themes and issues discussed during the Working Group meeting on June 2, 2015. The 5 key issues discussed as priorities were: (1) Review of the evidence on long-term immunity following immunization prior to 12 months of age; (2) Review of the optimal timing for routine MMR vaccine administration; (3) Administration of intravenous (IV) versus intramuscular (IM) immunoglobulin (lg) to pregnant and immunocompromised individuals for post-exposure prophylaxis; (4) Review of current travel recommendations; and (5) Review of the Canadian Immunization Guide (CIG) measles chapter.
Federal Led Action Plan on Vaccine Research, Innovation Development: Vaccine Priorities	Dr. Erling Rud, Senior Science Advisor for the Centre for Immunization and Respiratory Infectious Diseases provided a presentation on a draft Federal-Led Action Plan on Vaccine Research, Innovation and Development. The purpose of the presentation was to share the findings from consultations with the academic sector, industry, provinces and territories, medical experts, and other stakeholders on priority human and animal pathogens for vaccine research and development and to provide a status update on the draft Action Plan. The timeline and process for the finalization and release of the Action Plan has not been set at this time.
Evidence-based Methodology Working Group (EBM WG) Survey on Evaluation of NACI Products and Processes Update	An update on the Evidence-Based Methodology Working Group's activities, timelines and next steps was provided. The results of a critical appraisal of NACI statements using the AGREE II (Appraisal of Guidelines for Research & Evaluation) Assessment Tool were reviewed. Overall the appraisal indicated that NACI guidance products have improved over time and are comparable in quality to other similar guidance documents. NACI products scored highest in the "scope and purpose" and "clarity and presentation" domains. The preliminary results of a survey on NACI Products & Processes (April 14, 2015 to May 19, 2015) were reviewed. A total of 656 people responded to the survey. The majority of respondents rated NACI statements and the Canadian Immunization Guide trustworthy and of high quality. GRADE information sessions are being organized to support the EBM WG activities by providing an overview the steps and procedures used in the GRADE process.
Liaison and Ex-officio Representative Updates	Updates were provided by liaison and ex-officio representatives including the: Association of Medical Microbiology and Infectious Disease Canada, Canadian Immunization Committee, Biologics and Genetic Therapies Directorate (Health Canada), Canadian Association for Immunization Research and Evaluation, Canadian Paediatric Society, Canadian Public Health Association, US Centers for Disease Control and Prevention, Committee to Advise on Tropical Medicine and Travel, College of Family Physicians of Canada, Council of Chief Medical Officers of Health, First Nations and Inuit Health Branch, Health Canada, Marketed Health Products Directorate (Health Canada) and the Vaccine Safety Section (Public Health Agency of Canada).
Vaccinating Against Pain	Dr. Anna Tadio from the University of Toronto presented on research findings and clinical practice guidelines on pain and vaccination. The presentation reviewed the following topics: (1) rationale for reducing pain during vaccine injections, (2) methods used to develop and update clinical practice guidelines for reducing pain and fear during vaccine injections across the lifespan, and (3) recommendations.
CIG Part 1 Vaccine Administration Practices	Dr. Caroline Quach-Thanh presented a comparison between the recommended interventions against vaccine pain in HELPinKIDS and the Canadian Immunization Guide (CIG) text. Further review and comparison will be undertaken as part of the overall review of the CIG Vaccine Administration Practices chapter currently listed on the work plan.
Vaccine Safety Working Group (VS WG) Update	Dr. Blair Seifert, Working Group Chair provided an update on the VS WG activities. Several teleconferences of the VS WG were held to review and provide comments on the CIG Vaccine Safety Section and review and prioritize the NACI work plan safety-related topics.
Canadian Immunization Guide Vaccine Safety section	Dr. Barbara Law proposed revisions to the presentation of vaccine safety information in the CIG, Part 2 and 4, using the HPV chapter as an example, including the use of terms for AEFI frequency reporting (i.e., very common, common, uncommon, rare, very rare). NACI agreed to the general direction for the revisions. The VS WG will continue to map out the presentation of vaccine safety information in the CIG.
NACI Executive Secretary, General Business	The NACI Executive Secretary gave a brief overview of NACI business and activities in progress, including expected timelines. In regards to the recent call for membership to fill existing vacancies, applications have been received and are being reviewed with the NACI Chair and Vice-Chair. An overview of the vaccine industry pipeline submissions was also provided, highlighting additions and changes since the February meeting. The NACI Executive Secretary noted that as previously discussed the activation of the meningococcal and pertussis working groups are the next priorities, following the completion of products by currently active working groups.
Update on Live Attenuated Influenza Vaccine (Astra Zeneca)	Astra Zeneca provided an update on Live Attenuated Influenza Vaccine (LAIV) effectiveness.
Live Attenuated Influenza Vaccine	Dr. Deepali Kumar, Chair of the ad-hoc Live Vaccine Administration Working Group, presented three options for text to be included in the 2015-2016 seasonal influenza vaccine statement regarding the optimal intervals for the administration of LAIV and other live vaccines. The Ad-hoc working group reviewed evidence on potential immunologic interference following concomitant and sequential (less than 4 weeks apart) administration. NACI approved text will be incorporated into the 2015-2016 seasonal influenza vaccine statement.
Statement of Seasonal Influenza Vaccine for 2015-16	Dr. Nadine Sicard presented seven items and editorial changes for the 2015-2016 seasonal influenza statement for NACI review and approval: (1) inclusion of Fluad PediatricTM, (2) Choice of product for children 6-23 months, (3) Paediatric considerations for choice of product in regards to Influenza B, (4) Recommendation for LAIV and Children with cystic fibrosis, (5) Recommendation for Q-LAIV using evidence from trivalent LAIV, (6) Update on decreased LAIV effectiveness seen in the USA, and (7) Optimal interval for administration of LAIV and other live vaccines (as per Agenda Item above).
Statement: Hepatitis A	Dr. Bonnie Henry provided an update on the Hepatitis Working Group. The Hepatitis A statement update was presented for NACI review. The statement update will be revised and NACI approval will be sought following the meeting. The Hepatitis B statement has been delayed pending results from an HBV study currently underway in British Columbia.
National Immunization Strategy (NIS)	Ms. Gina Charos, Centre for Immunization and Respiratory Infectious Diseases provided an update on the Public Health Network review of the NIS.
Common Vaccine Guidance	The Executive Secretary, Robert Lerch provided an update on the work underway since the February 2015 meeting on Common Vaccine Guidance including the integration of additional elements into one vaccine guidance process (i.e. acceptability, economic evaluation). The development of a common vaccine guidance process will be continuing over the summer and fall.
Adjournment	The Chair thanked members for their contributions.

February 2015

Summary of Discussion February 4-5, 2015 Meeting, Ottawa, Ontario
Agenda Item	Summary
Welcome and Introduction	The Chair, Dr. Ian Gemmill, welcomed participants to the meeting. The Chair introduced two new Ex-officio representatives, Althea House, Acting Director, Influenza and Other Respiratory Infectious Diseases Division, Public Health Agency of Canada (the Agency) and Dr. Tom Wong, First Nationals and Inuit Health Branch, Health Canada. Dr. John Spika, Director General, Centre for Immunization and Respiratory Infectious Diseases provided a short debrief from the recent Canadian Immunization Conference. He alerted NACI to the recently completed revision of the resource, A Parent's Guide to Immunization (first published in 2009), which is now ready for distribution. Dr. Spika also informed NACI that as part of a pilot regarding collaboration among immunization guidance producers, a liaison representative from the Comité sur l'immunisation du Québec (CIQ) has been invited to join NACI.
Developing an analytical framework for the post-implementation evaluation of Immunization Programs in Canada	Dr. Maria Eugenia Espinoza provided a presentation on a standardized logic model for the post-implementation of Canadian immunization programs, identifying vaccination program objectives, resources, activities, outputs and outcomes at different levels, as well as their interrelations. The model can assist in optimizing planning, implementation and communication and capacity building activities. The model is currently being validated, looking at its overall structure, components, level of complexity, and value in regards to monitoring and evaluation purposes. As part of a consultative process, the framework has been previously presented to various stakeholder groups across Canada, as well as to the Agency. The framework can be helpful in the identification of deficiencies and areas for improvement in immunization programs. Following validation there are plans to undergo pilot testing of the model.
Evidence-based Methodology Working Group (EBM WG)	An update was provided on the progress of the EBM working group, which was initiated to review NACI's methodology and provide recommendations for improvement. A project charter summary was presented, which included the objectives, activities (phases) and deliverables. The critical appraisal of select NACI products with the AGREE II tool is underway. A draft survey questionnaire to collect stakeholder views/opinions on NACI's methodology and products was presented for discussion, including the distribution strategy. The survey is expected to be ready for dissemination in a couple of months.
Statement: Update on Measles-Mumps-Rubella-Varicella Vaccine (MMRV) and Febrile Seizures	The MMRV and Febrile Seizures statement was initially presented and discussed at the October 2014 meeting. The statement has been updated following the October meeting with input from the Vaccine Safety Working Group. The goal of the statement is to update the available evidence on MMRV and febrile seizures. The statement was approved in principle with some suggested changes but requiring final statement approval be completed via email following the meeting.
Statement: Rotavirus Vaccines and Intussusception	A short statement update discussing risks and benefits of rotavirus vaccination was presented to NACI as per the decision at the June 2014 meeting. The statement includes a review of recent data on intussusception as well as a discussion on benefits of vaccination. The statement was approved in principle with final statement approval following minor changes, to be completed via email following the meeting.
National Immunization Strategy (NIS) Update	The Associate Director General, Centre for Immunization and Respiratory Infectious Diseases provided an update on the Public Health Network review of the NIS.
Vaccine Safety Working Group (VSWG)	As a standing item on the agenda, the Working Group Chair informed NACI that the Working Group will be reviewing, refining and prioritizing safety items from the Canadian Immunization Guide (the Guide)/NACI work plan. The working group continues to meet regularly to review and discuss any new safety evidence/information, including Adverse Event Following Immunization and Canadian Adverse Events Following Immunization Surveillance System data.
Pharmacovigilance Information Session	Dr. Blair Seifert provided a presentation to NACI on pharmacovigilance. The presentation was intended to provide members with general information on pharmacovigilance, safety assessment, tools and specific issues related to immunization including the World Health Organization Global Vaccine Safety Initiative.
Hepatitis A-B Working Group Update	The Working Group Chair provided NACI with an update on activities in progress and next steps. There are currently two statements under working group review. Five issues are under review; the off label use of the Hepatitis A vaccine in infants 6-11 months, the need for / timing of a Hepatitis B (HB) booster in adolescents vaccinated in infancy, the need for a Hepatitis B booster in immunocompromised persons, the risk of Hepatitis B infection in diabetics, and the timing and indications of HBIg. Two additional items will be reviewed by the working group, following NACI discussion during the meeting: (1) Post-exposure prophylaxis in individuals ≥50 years of age and those with chronic liver disease; and (2) Optimal timing of primary HB vaccine and recommendations of a birth dose.
Human Papillomavirus (HPV) Working Group Update	The Working Group Chair presented an update on work plan activities and progress to date including: (1) 2-dose schedule recommendations, (2) minimum intervals for 3-dose schedule (3) immunocompromised patients and (4) nonavalent vaccine. The HPV 2-dose statement is expected to be posted online in the following weeks. The Guide HPV chapter will also be updated based on the 2-dose statement.
Adult Immunization Continuing Medical Education (CME) Update	Information was provided on an online adult immunization CME developed by mdBriefCase with support from the Agency. The eCME, directed to health care workers, highlights new/updated NACI recommendations and provides practical strategies and tips to manage and counsel patients.
Statement: Seasonal Influenza Vaccine 2015-2016	The Working Group Chair presented a literature review on Fluad Paediatric for NACI discussion, summarizing the available evidence on the vaccines efficacy, effectiveness, immunogenicity and safety in children 6 to 72 months of age. Resulting recommendations for the vaccine to be included in the 2015-2016 seasonal influenza vaccine statement, expected to be released in summer 2015. The 2015-2016 seasonal influenza statement and remaining items for discussion were presented to NACI.
Recommended Intervals for administration of live vaccines	Following the October 2014 meeting an ad-hoc working group was established to review the evidence and recommendations on the intervals for non-concomitant live vaccine administration. The working group will begin by reviewing intervals for live attenuated influenza and other vaccines. The working group is expected to present to NACI during the June meeting.
Canada Communicable Disease Report (CCDR)/Knowledge Translation	Dr. Patricia Huston, CCDR Scientific Editor, provided an update on the revitalization of CCDR. The CCDR is a peer-reviewed, online, open access journal on infectious diseases in Canada published by the Agency. The CCDR provides regular communications to clinicians, public health professionals and others including national surveillance summaries on infectious diseases and public health guidance. Subscriptions rates have doubled since the work on the revitalisation of the CCDR began. Currently, NACI statement summary tables are posted on the Agency website with a link to the full statement on publications.gc.ca. As an additional knowledge translation tool, a CCDR summary for NACI statements was discussed and agreed to by members. The CCDR summary will provide key information from the full statement, outlining the methods, results and final recommendations.
General Business	NACI members were provided with a status update on current NACI activities and the overall work plan items.
Liaison and Ex-Officio Representative Updates	Updates were provided by liaison and ex-officio representatives including the: Association of Medical Microbiology and Infectious Diseases Canada (AMMI), Biologics and Genetic Therapies Directorate (Health Canada), Canadian Association for Immunization Research and Evaluation (CAIRE), Centers for Disease Control and Prevention (CDC), Committee to Advise on Tropical Medicine and Travel (CATMAT), Council of Chief Medical Officers of Health (CCMOH), College of Family Physicians of Canada (CFPC), Canadian Immunization Committee (CIC), Canadian Public Health Association (CPHA), Canadian Paediatrics Society (CPS), National Defence and the Canadian Armed Forces (DND), First Nationals and Inuit Health Branch (Health Canada), Marketed Health Products Directorate (Health Canada), and the Society of Obstetricians and Gynaecologists of Canada (SOGC).
Adjournment	The Chair thanked members for their contributions and adjourned the meeting.

October 2014

Summary of Discussion June 4-5, 2014 Meeting, Ottawa, Ontario
Agenda Item	Summary
Opening Remarks	The Chair, Dr. Ian Gemmill, welcomed participants to the meeting. The Chair introduced a new liaison representative, Dr. Catherine Mah from the Canadian Public Health Association, and two new ex-officio representatives from Health Canada, Dr. Jim Gallivan from Marketed Health Products Directorate and Dr. Gina Coleman from Biologics and Genetic Therapies Directorate. Dr. John Spika, Director General, Centre for Immunization and Respiratory Infectious Diseases acknowledged the appointment of Dr. Gregory Taylor as the new Chief Public Health Officer. Dr Spika also informed NACI members that Dr. Caroline Quach-Thanh will be the incoming NACI Vice-Chair, with her two year term beginning immediately following the meeting. NACI's 50^th anniversary was acknowledged as well as the important role it has played in Canada since 1964.
Prevalence of HPV genotypes in HPV-related cancers and cervical pre-cancers in Canada and overview of 9-valent (9vHPV) vaccine program - key results	The presentation by Merck assessed the current evidence on the prevalence of HPV 6, 11, 16, 18, 31, 33, 45, 52 and 58 genotypes in Canada for HPV-related cancers as well as cervical precancerous lesions. The investigational 9-valent HPV VLP vaccine (9vHPV) includes the 4 HPV types (6, 11, 16, 18) in the 4vHPV vaccine and 5 additional oncogenic types (31, 33, 45, 52, 58). The 9vHPV vaccine has the potential to broaden protection for cervical cancer and precancers, as well as for other HPV-related cancers and precancers. An overview of the 9vHPV vaccine clinical development program and results from the clinical trials were provided.
Statement: Human Papillomavirus 2-dose Schedule	An update of the progress to date and draft recommendations were provided to NACI. NACI approved the recommendations with minor edits. Final Chair approval to be sought following the meeting.
Statement on Seasonal Influenza Vaccine for 2015-16	The Influenza Working Group Chair gave a brief description of the Agenda Item. The following presentations were provided to NACI for consideration in the 2015-16 influenza vaccine statement, as appropriate. Findings of a literature review on Pediatric Fluad^®Influenza Vaccine Use in Children 6-72 Months of Age. Findings of a literature review on Fluzone^®High-Dose vaccine. A review of evidence on reduced immunogenic responses in young children, 6-72 months, as a potential factor related to differences in product use. Following the presentations, the new format for 2015-16, combining the Canadian Immunization Guide Chapter on Influenza and the annual statement on seasonal influenza vaccine was presented.
Concomitant Administration of Live Vaccines	NACI members discussed the current recommendation for LAIV administration with other live vaccines and decided that a review of the evidence should be conducted to inform a future committee discussion. An ad-hoc working group is to be established to complete the evidence review and present the findings to NACI.
Risk of febrile seizures following MMRV	A review of the current NACI recommendations and a recent evidence review were presented to NACI. A draft statement update will be completed with the NACI Vaccine Safety and other relevant working groups for further review and consideration by NACI during the February meeting.
Statements: Hepatitis A and B	The Hepatitis A & B Working Group provided an overview of their activities from May to September 2014, including proposed next steps. Five issues were discussed by the working group; the off label use of the Hepatitis A vaccine in infants 6-11 months, the need for / timing of a Hepatitis B (HB) booster in adolescents vaccinated in infancy, the need for a Hepatitis B booster in immunocompromised persons, the risk of Hepatitis B infection in diabetics, and the timing and indications of HBIg. An update and presentation of draft items, if available, will be provided to NACI during the February meeting.
Statement: Varicella Immune Globulin (VarIg) Update	Current NACI recommendations were reviewed as well as drat text for a statement update for an expanded time period for post-exposure management in susceptible persons; 10 days versus 96 hours in the current recommendations. The draft recommendations and statement update will be presented to NACI for final approval either before or during the February meeting.
Statement: Re-Immunization with Polysaccharide 23-Valent Pneumococcal Vaccine (Pneu-P-23)	Recommendations in the Pneu-P-23 statement, approved by NACI in July 2014, were reviewed and confirmed by NACI. The statement will be submitted for the Chair's final approval following the meeting.
ACIP PCV13 Recommendation for all adults ≥65 years of age	NACI discussed the ACIP approved PCV13 recommendations for all adults ≥65 years of age, which were voted on during an ad-hoc meeting in August 2014. The initiation of a NACI work plan item to be further discussed with the Pneumococcal Working Group.
Liaison and Ex-officio Representative Updates	The following liaison and ex-officio representatives provided updates from their host organization, if available. Liaison Representatives: Association of Medical Microbiology and Infectious Disease Canada (AMMI); Canadian Association for Immunization Research and Evaluation (CAIRE); Canadian Immunization Committee; Canadian Paediatric Society (CPS); Canadian Public Health Association (CPHA); Centers for Disease Control and Prevention (CDC); College of Family Physicians of Canada (CFPC); Council of Chief Medical Officers of Health (CCMOH); and Society of Obstetricians and Gynaecologists of Canada (SOGC). Ex-officio Representatives: Biologics and Genetic Therapies Directorate (BGTD), Health Canada; Marketed Health Products Directorate, Health Canada; National Defence and the Canadian Armed Forces; Centre for Immunization and Respiratory Infectious Diseases, Public Health Agency of Canada.
Canadian Immunization Guide (the Guide)	An update was provided on the Guide review process and revisions in progress. Feedback was sought from NACI on a proposed review schedule, 2014 to 2018, based on comments received at the NACI June 2014 meeting.
Canadian Communicable Disease Report (CCDR) Canadian Immunization Guide (the Guide) Commentary	A CCDR commentary was published in April 2014 to inform readers of key changes in Part 4 of the Guide, Active Vaccines. NACI agreed that this would be a useful knowledge translation tool going forward to inform readers of future changes in the Guide.
Vaccine Safety Working Group Update	The working group chair provided an update on their activities, including discussion and review of evidence on rotavirus and influenza vaccination and the collection of data on vaccine administration errors.
Tdap discussion on question regarding vaccination of medical students	PHAC received an inquiry pertaining to the vaccination of medical school students, seeking clarification on the current Tdap recommendations in the Guide. This issue was discussed at the June meeting and brought back to NACI for further discussion and decision. NACI confirmed the interpretation of the recommendations in the Guide; young adult health care workers should be vaccinated when starting clinical work if they have not previously received Tdap in adulthood, regardless of when Tdap was given in adolescence. NACI also noted that there is a need to review the evidence on the timing of the adolescent booster dose at a future meeting.
General NACI Business	NACI members were provided with a status update on current activities / timelines. NACI members also discussed the committee's work plan item list and future priorities.
National Immunization Strategy (NIS)	The Associate Director General, Centre for Immunization and Respiratory Infectious Diseases provided an update on the Public Health Review of the NIS.

June 2014

Summary of Discussion June 4-5, 2014 Meeting, Ottawa, Ontario
Agenda Item	Summary
Opening Remarks	The Chair, Dr. Bryna Warshawsky, welcomed participants to the meeting. The Chair introduced the new Liaison Representative, Ms. Elaine Sartison, from the Canadian Immunization Committee and welcomed back Dr. Jason Brophy, the Liaison Representative from the Canadian Association for Immunization Research and Evaluation. The Chair also welcomed Dr. Shelley Deeks, who has been appointed as a NACI voting member. As today's meeting marked the end of Dr. Bryna Warshawsky's term as Chair of the committee, Dr. John Spika, Director General of the Centre for Immunization and Respiratory Infectious Diseases expressed his appreciation for the dedication and efforts of Dr. Warshawsky over the past 3 years as Chair. He also informed the group that Dr. Ian Gemmill will be the incoming NACI Chair.
CAPiTA (Community-Acquired Pneumonia Immunization Trial in Adults)	CAPiTA results were presented. The primary outcome of the trial was to establish the efficacy of Prevnar 13 in the prevention of a first episode of confirmed, vaccine-serotype, pneumococcal community-acquired pneumonia in adults 65 years and older.
Epidemiology of Community Acquired Pneumonia (CAP) in Canada	Dr. Shelly McNeil, Canadian Centre for Vaccinology, Dalhousie University, Nova Scotia, presented data on community acquired pneumonia and invasive pneumococcal disease among hospitalized adults from a Canadian active surveillance network, the Serious Outcomes Surveillance (SOS) network of PCIRN. The data were collected from a subset of SOS network sites, 9 hospitals/facilities; December 2010 to December 2013.
Evidence-based Methodology Working Group (EBM WG)	The NACI EBM WG has been activated to assess and recommend improvements to NACI's current evidence-based methodology and product templates. A draft project charter was presented. The goal of this project is to improve and update NACI's current evidence-based methodology and products by: identifying and prioritizing key issues and areas for improvement, developing strategies to address priority issues and areas for improvement, and drafting revised templates and processes for improved NACI products. The EBM WG will further develop its membership and timelines, returning to NACI in October with an update.
Facilitated Discussion on Proposals for Common Guidance (CVG)	NACI discussed the Common Vaccine Guidance which is part of the National Immunization Strategy review. The goal of the discussion was to seek insights and suggestions regarding key qualities and features of the common guidance process and products/outputs.
Tdap discussion on the question regarding vaccination of medical students	PHAC received an inquiry pertaining to the vaccination of students entering medical school. The inquirer is seeking clarification on the current Tdap recommendations in the Canadian Immunization Guide (the Guide): all health care and child care workers, regardless of age, should receive a single dose of Tdap vaccine for pertussis protection if not previously immunised in adulthood, even if they are not due for a tetanus and diphtheria booster. Additional information will be sought from NACI members not in attendance at the meeting prior to clarifying the recommendations in the Guide.
Seasonal Influenza	The Influenza Working Group (IWG) Chair provided an update on the 2014-2015 Seasonal Influenza Vaccine Statement. The Chair of the IWG informed NACI that the statement would be finalized and disseminated to stakeholders this summer, with web publication to follow. The IWG Chair proposed a new format for the influenza statement and the chapter in the Canadian Immunization Guide (the Guide) following discussions with the IWG and staff within the Agency. The new format is meant to make the products more user-friendly, as well as to make their development more efficient. There are two major stakeholder groups with different needs, which we are trying to meet with the NACI influenza products: 1) the Guide influenza chapter for clinicians who want a resource which is short, summarized, and is easy to use; and 2) the statement for users who require more detailed information and evidence. The proposed format will be used to draft the 2015-2016 statement in order for NACI to decide on whether this is the best approach going forward.
Validity of self-reported history of varicella disease as proof of immunity	A literature review was presented to NACI for their review/discussion. A statement will be drafted by the Varicella Working Group for NACI review and approval.
Canadian Immunization Guide (the Guide) Update	A brief update on the Guide was provided, including the new subscribe feature. This feature will be used to alert subscribers by email when new information or updates have been completed for the Guide and other NACI products. This feature, in addition to the Table of Updates for the Guide, will be used to keep readers up-to-date on NACI recommendations and the evergreen edition of the Guide. An ongoing review process and schedule to ensure regular updates for the Guide was presented to NACI. Following a transition year, an ongoing cycle of chapters review will be implemented. It was proposed that, in addition to periodic updates to a chapter following the release of a NACI statement/update, chapters will be reviewed on a 4 year cycle. Following further refinement, the process and schedule will be finalized by NACI.
Human papillomasvirus (HPV) Working Group Update	The Working Group Chair for HPV vaccine presented a proposal to have the WG draft a statement update on a 2-dose vaccination schedule, to be completed this summer/fall. NACI agreed to the proposal.
Vaccine Safety Working Group (NACI-VS WG) Update	A status update was provided on the NACI-VS WG. The WG Vice-Chair presented a review of recent data on intussusception following Rotavirus vaccination. This information will be used to inform a short statement update on Rotavirus vaccination for review/approval by NACI. The timing of this review/approval to be determined following the meeting and discussion with the Rotavirus WG Chair.
National Immunization Strategy (NIS)	The Associate Director General, Centre for Immunization and Respiratory Infectious Diseases provided an update on the Public Health Network review of the NIS.
Liaison and Ex-Officio Representative Updates	Updates were provided by liaison and ex-officio representatives including the: Council of Chief Medical Officers of Health (CCMOH), Canadian Public Health Association (CPHA), Canadian Paediatrics Society (CPS), Association of Medical Microbiology and Infectious Diseases Canada (AMMI), Canadian Immunization Committee (CIC) and the College of Family Physicians of Canada (CFPC).
Adjournment	The Chair thanked members for their contributions and members congratulated the retiring Chair, Dr Warshawsky, for her tireless leadership over the last three years. The meeting then was adjourned.

February 2014

Summary of Discussion February 5-6, 2014 Meeting, Ottawa, Ontario
Agenda Item	Summary
Opening Remarks	The Chair, Dr. Bryna Warshawsky, welcomed participants to the meeting. Dr. John Spika, Director General, Centre for Immunization and Respiratory Infectious Diseases (CIRID), Public Health Agency of Canada (the Agency), expressed his appreciation, on behalf of the Agency, for all the hard work and accomplishments of NACI. Dr. Judith Bossé Assistant Deputy Minister was introduced and gave a brief background on herself. Gina Charos, was introduced as the new Director of the Immunization Program and Promotion Division, CIRID. The Chair presented the new Liaison Representatives, Dr. Martin Lavoie, Council of Chief Medical Officers of Health, Dr. Julie Emili, College of Family Physicians of Canada. The Chair also introduced a new Ex-officio, Dr. Diego Garcia, First Nations and Inuit Health Branch, Health Canada, and welcomed them to their first NACI face to face meeting.
Fluzone^®High Dose Vaccine and FIM12 Efficacy Trial Results	Sanofi Pasteur presented their data on a randomized controlled trial of Fluzone^®High Dose (HD) vaccine compared to standard-dose Fluzone^®vaccine. Additionally, Sanofi Pasteur is working on an economic analysis.
Update on the Quadrivalent Influenza Vaccines	An update was given to the group in regards to the procurement process, status update and future plans for the Quadrivalent Influenza Vaccines.
Cervarix^®2-dose schedule - GlaxoSmithKline	GlaxoSmithKline presented their data on immunogenicity and safety of Cervarix^®2-dose schedule in girls aged 9 to 14 years old.
Presentation of the systematic review on the need for boosting with PPV23	A McGill University Masters student gave a presentation on the systematic review of the literature conducted in order to determine if the optimal timing for the 23-valent pneumococcal vaccine booster for high-risk groups could be established.
Statement: Update on Quadrivalent meningococcal Vaccines available in Canada	An update of the progress to date and the next steps and timelines were provided to NACI. Members then discussed a few key issues which arose during the statement review process.
NACI Work plan	NACI was presented with a revised list of items to be considered for the NACI work plan as well as key activities that should be considered a priority for NACI in the upcoming future. The revised and prioritized list will be further refined with the input received from participants at the meeting.
General NACI Business	NACI members were provided with a status update on current NACI activities.
Liaison and Ex-Officio Representative Updates	The following liaison and ex-officio representatives provided updates from their organization if updates were available: Council of Chief Medical Officers of Health (CCMOH), U.S. Centers for Disease Control and Prevention (CDC), Canadian Public Health Association (CPHA), Canadian Paediatrics Society (CPS), Association of Medical Microbiology and Infectious Diseases Canada (AMMI), Canadian Association for Immunization Research and Evaluation (CAIRE), The Agency's Canadian Immunization Committee (CIC), College of Family Physicians of Canada (CFPC), Health Canada's First Nations and Inuit Health Branch (FNIHB), The Agency's Committee to Advise on Tropical Medicine and Travel (CATMAT), and Health Canada's Biologics and Genetic Therapies Directorate (BGTD) and Marketed Health Products Directorate (MHPD).
National Immunization Strategy (NIS)	The Associate Director General, Centre for Immunization and Respiratory Infectious Diseases provided an update on the Public Health Network review of the NIS.
Update on the Canadian Immunization Guide (the Guide)	NACI was presented with the current status of the Canadian Immunization Guide (the Guide) renewal. Recent page views for the the Guide revised chapters were provided, along with an update on the status of the PDFs for each chapter. NACI members were invited to send in feedback requesting other web statistics to help inform how the Guide is being accessed and used.Moving forward with the online version, the plan is to update all chapters by February 2016. The Working Group Chairs and NACI Chair will be reviewing the chapters as they are prepared. A short presentation was also given in order to inform NACI on how the Agency and Centre is approaching a strategic and streamlined approach to managing web published information. NACI was given a live demonstration of how the Centre products will be presented on the Agency web site.
Facilitated Discussion on Common Guidance Development	NACI discussed the Meningococcal B statement and process as an example of guidance that includes both scientific and programmatic recommendations.
Manufacturers Guidelines comments from Vaccine Industry Committee	This Agenda Item was deferred.
Literature Review Process and Approval	An issue discussed at the last NACI Executive meeting regarding the ownership, review and approval of literature reviews was brought forth to NACI and subsequently discussed by the group.
Evidence-based Medicine Working Group brainstorming	This Agenda Item was rescheduled and is to be discussed at the June 2014 NACI face to face meeting.
Adjournment	The Chair thanked members for their contributions and the meeting was adjourned.

October 2013

Summary of Discussion October 9-10, 2013 Meeting, Ottawa, Ontario
Agenda Item	Summary
Opening Remarks	The Chair, Dr. Bryna Warshawsky, welcomed participants to the meeting. Dr. John Spika, Director General, Centre for Immunization and Respiratory Infectious Diseases (CIRID), Public Health Agency of Canada (the Agency), expressed his appreciation, on behalf of the Branch, for all the hard work and accomplishments of NACI. He informed participants of the significant increase in Agency web page views for the revised Canadian Immunization Guide chapters posted to date. Dr. Spika also informed NACI members that a call is being prepared to solicit applicants for the current vacancy on the committee as well as other upcoming vacancies over the next few years.
Statement: 2014-15 Seasonal Influenza Vaccine Statement and Literature Review	The Influenza Working Group (IWG) chair provided members with some background information on the discussion that occurred on the previous NACI teleconference on the preferential recommendation for LAIV use in children and adolescents 2-17 years of age. Two options for revised wording for the recommendation were presented to the committee for a vote. The revised recommendation will be finalized following the meeting, and following Agency approval, it will be disseminated to immunization stakeholders. Recommendations for healthy 5-18 and 19-64 year olds were discussed based on two literature reviews which were presented to NACI during a recent teleconference. The recommendations and the draft 2014-2015 statement will be discussed in November, with the final statement expected to be ready for dissemination to immunization stakeholders in early 2014. During the November meeting, a literature review on quadrivalent influenza vaccines will also be presented and discussed.
Project Update: Advice for the Use of Four Component Meningococcal Serogroup B (4CMENB) Vaccine	An update of the progress to date and the next steps and timelines were provided to NACI. The NACI relevant components of the statement will be brought back to NACI for final vote pending market authorization. Further discussion on next steps and the overall approval process will be confirmed and shared at an upcoming NACI meeting. The Task Group leading the development of the vaccine guidance document will be meeting later in October to review additional components of the document and discuss process issues.
General NACI Business	NACI members were provided with a status update on current NACI activities. Members agreed on the current format for the status update going forward. With regard to the Advisory Committee on Immunization Practices (ACIP) meetings, notes are prepared following the meeting and shared with NACI. Members agreed that it would be useful for the ACIP meeting agenda to be shared with the committee when it becomes available. Additionally, members agreed that the notes prepared following the meeting were useful and should be continued.
Voting Process/NACI working groups and voting members on working groups	Issues were raised with regards to the number of NACI members that should be on each working group. During a recent NACI Executive meeting a minimum of 2, in addition to the Chair, was proposed for consideration by NACI. Some members pointed out that some working groups are mainly composed of external experts. The current Terms of Reference for NACI indicate that a quorum of 2/3 of NACI members is required to authenticate a vote. Although a quorum of 7 members is needed to vote, for a vote to stand in favour of a recommendation 6 members (50% of the full NACI membership) must vote in favour. For working group consensus, a quorum of 2/3 of members is also required. Another point raised surrounded the need for an objective and fair process to recruit external experts. It was suggested and agreed that a periodic open call be made for external experts for all NACI working groups.
NACI Work plan	NACI was presented with a revised list of items to be considered for the NACI work plan, following presentation of the original list in June 2013. The revised and prioritized list will be further refined with input from within the Agency and external partners/committees.
Statement: Update on the Use of Conjugate Pneumococcal Vaccine for Asthmatics	The draft statement and recommendations was presented to NACI for discussion. Final approval of the statement and its recommendations will take place via email following the meeting.
Statement: Update on the Use of Quadrivalent Conjugate Meningococcal Vaccines	The draft statement and recommendations were presented to NACI for their first review/discussion. The Working Group will be revising and recirculating the draft statement to NACI following the meeting.
Update on the Evergreen Canadian Immunization Guide (CIG)	Recent page views for the CIG revised chapters were provided, noting the significant increase in web traffic since the new chapters have begun to be posted. Individual chapter page statistics will be prepared for an upcoming NACI meeting. It was proposed to the committee that for some chapters in the Guide, the epidemiology section could be refined and refer readers to epidemiological information posted on other pages on the Agency website. This approach will be piloted and further reviewed. An update schedule for the Guide will be prepared for NACI for future consideration. A feedback mechanism for users of the Guide would be useful. Further consideration will be given to this item.
NACI Methodology and Template	The discussion from the previous NACI meeting on its methodology was continued during the current meeting. It was agreed that there is the need to review and assess the NACI methodology to determine where improvements could be made. As a part of this work, the NACI template will also be reviewed. The item will be added to the list of NACI work plan items for further consideration. The NACI Evidence-Based Working Group will be the vehicle for completing this work. It was proposed that NACI literature reviews could be published as articles in the Canadian Communicable Disease Report (CCDR) instead of publishing the full review document. NACI members agreed that publishing the full literature review document online is needed in addition to any other knowledge translation and transfer activities. It was acknowledged that the web publishing of NACI products on the Agency's web site has been delayed due to the new Government of Canada web renewal and accessibility standards. It was proposed that as a short term solution, a summary of a NACI statement could be posted as a CCDR supplement with access to the full document upon request. NACI members again agreed that access to the full document is needed online in addition to any other knowledge translation and transfer activities undertaken.
Timeframes for the development of NACI statements	The addition to the NACI statement review process of an early Canadian Immunization Committee (CIC) review, prior to pre-release, was presented. This was in response to a CIC request for an earlier review of NACI statements. NACI members agreed that a high level review by CIC would be beneficial to CIC as well as NACI. An early review by CIC will be undertaken on a trial basis with clear direction on the type of review and timelines to be included.
Liaison and Ex-Officio Representative Updates	Updates were provided by liaison and ex-officio representatives including the: Council of Chief Medical Officers of Health (CCMOH), Canadian Public Health Association (CPHA), Canadian Paediatrics Society (CPS), Association of Medical Microbiology and Infectious Diseases Canada (AMMI), Canadian Association for Immunization Research and Evaluation (CAIRE), Canadian Immunization Committee (CIC), College of Family Physicians of Canada (CFPC), Department of National Defence (DND), Health Canada's First Nations and Inuit Health Branch (FNIHB), Committee to Advise on Tropical Medicine and Travel (CATMAT), and Health Canada's Biologics and Genetic Therapies Directorate (BGTD).
National Immunization Strategy (NIS)	The Associate Director General, Centre for Immunization and Respiratory Infectious Diseases provided an update on the Public Health Network review of the NIS.
Adjournment	The Chair thanked members for their contributions and the meeting was adjourned.

June 2013

Summary of Discussion June 5-6, 2013 Meeting, Ottawa, Ontario
Agenda Item	Summary
Opening Remarks	The Chair, Dr. Bryna Warshawsky, welcomed participants to the meeting. Dr. Ian Gemmill was introduced as the new Vice-Chair for NACI. New Liaison representatives, Dr. Shelley Deeks from CPHA and Dr. André Corriveau from CCMOH were introduced and welcomed to NACI. New ex-officio representative, Dr. Paul Eagan from the Department of National Defense and Canadian Forces was introduced and welcomed to NACI. As this was Dr. Shelly McNeil's last NACI meeting, she was thanked for her significant contributions and commitment to NACI over the past 8 years.
Canadian Immunization Guide (CIG) Planning	A status report on the CIG revision was provided. The seven remaining chapters are to undergo second and final NACI review at this meeting. Following the final revisions, the chapters will be sent to Working Group Chair and NACI Chair for approval. The significant effort and commitment of NACI and the CIG team were acknowledged. The web posting strategy for the CIG was also discussed and members were given an update on the progress and schedule for chapters being posted. Several suggestions were provided on alerting readers to updates including the use of an RSS feed. The NACI/CIG Team will continue to develop the Evergreen plan and circulate to NACI and/or present it at an upcoming meeting for additional input.
First review Part 1 CIG Chapter: Basic Vaccinology	This was NACI's second and final review of the Basic Vaccinology chapter. Members reviewed the issues raised during the first review of the chapter. The chapter was approved with identified edits and changes.
First Review Part 1 CIG Chapter: Storage and Handling	This was NACI's second and final review of the Storage and Handling chapter. Members reviewed the issues raised during the first review of the chapter. The chapter was approved with identified edits and changes.
First Review Part 1 CIG: Recent Administration of Human Ig	This was NACI's second and final review of the Recent Administration of Human Immune Globulin Products chapter. Members reviewed the issues raised during the first review of the chapter. The chapter was approved with identified edits and changes.
Final review Part 5 CIG Chapter: Passive Immunization	CIG Chapter: Passive Immunization This was NACI's second and final review of the Passive Immunization chapter. Members reviewed the issues raised during the first review of the chapter. The chapter was approved with identified edits and changes.
Final Review Part 4 CIG Chapter/CATMAT: Typhoid	The Committee to Advise on Tropical Medicine and Travel (CATMAT) and NACI reviewed the chapter. This was the second and final review of the Typhoid chapter. Members reviewed the issues raised by NACI and CATMAT during the first review of the chapter. The chapter was approved with identified edits and changes.
Final Review of Part 1 CIG Chapter: National Guidelines	This was NACI's second and final review of the National Guidelines chapter. Members reviewed the issues raised during the first review of the chapter. The guidelines were included in previous editions of the CIG. When these were first created they were developed in consultation with a number of organizations. The chapter will be reviewed to ensure that it aligns with the policy directions of the National Influenza Strategy (NIS) renewal prior to finalization.
Final review Part 1 CIG Chapter: Immunization Records	This was NACI's second and final review of the Immunization Records chapter. Members reviewed the issues raised during the first review of the chapter. The chapter was approved as presented.
CIG Evergreen Process	A process to update/keep up-to-date CIG chapters was presented. Small changes, such as the correction of information, would include a simple review and approval process. Larger changes would require more extensive review and approval processes. The proposed CIG chapter changes would be incorporated by the NACI/CIG Team and approved by the working group and NACI Chair and Vice-Chair. A plan for regular updates to chapters was also included in the strategy. The NACI/CIG Team will further refine the Evergreen plan and circulate to NACI and/or present it at an upcoming meeting for additional input.
Case example: CIG Influenza Chapter	During the last NACI Executive meeting several options for the influenza chapter were discussed. The proposed approach from the Executive meeting was brought forward to NACI for further input. Members agreed that the chapter will follow the CIG template taking text directly from the influenza statement where appropriate. Additionally, the chapter will be approved in tandem with the statement so that they are ready at the same time.
Statement: 2013-2014 Seasonal Influenza Vaccine Statement	The Influenza Working Group (IWG) Chair led the discussion. The definition of health care workers was discussed with members agreeing that the intent of this section in the statement was to be all inclusive of those within the health care setting. Issues surrounding vaccine administration, Guillain Barré Syndrome, vaccine effectiveness evidence, duration of immunity and co-administration with mucosal vaccines were also discussed. The statement will be revised accordingly and circulated to the committee for approval following the meeting.
2013-14 NACI Work Plan Items	In order to inform the 2013-14 work plan, several documents were reviewed to create a list of items for consideration, including the NACI running list of items from the CIG revision. The list of work plan items will be sent to NACI for comment / refinement following the meeting. Once the key questions and issues are identified the work plan items will be prioritized. Once the NACI work plan has been further refined, it will be shared with the Priorities Committee, identified in the NACI Terms of Reference, for comment/input.
NACI General Business	The Status Report on NACI Activities was reviewed. Members were updated on the web posting of CIG chapters and future NACI Statements and Updates.
National Immunization Strategy (NIS)	The Associate Director General, Centre for Immunization and Respiratory Infectious Diseases provided an update on the Public Health Network review of the NIS.
Developing Evidence-based Vaccine Recommendations (DEVR)	An update was provided on the work of the DEVR Committee, the special advisory committee to the ADM-IDPC. The committee, including members from NACI and the Committee to Advise on Tropical Medicine and Travel (CATMAT) assessed different approaches to developing evidence-based recommendations within and external to the Agency. NACI members were asked for feedback on the use of a modified GRADE approach for immunization recommendations. Members did not feel that a modified GRADE approach is needed. They felt that what is needed for NACI is a review of its current methodology and identification of potential elements that could improve current practices.
Statement: Update on the Use of Conjugate Pneumococcal Vaccine for Asthmatics	A literature review and a draft statement were presented to NACI for feedback and comments. The statement will be finalized and approved via email following the meeting.
Statement: Advice for the Use of the Four Component Meningococcal Serogroup B (4CMENB) Vaccine	An update on Meningococcal B Pilot Project Task Group activities and the common guidance document was provided. With the preliminary vote completed by NACI on the scientific recommendations, the task group will now be focusing on the programmatic elements of the document. NACI will be provided with additional updates at an upcoming meeting.
Statement: Update on the Use of Quadrivalent Conjugate Meningococcal Vaccines	A presentation was provided on the issues and products which the NACI Meningococcal working group will be considering. A working group meeting is being planned for the summer to develop a work plan and timeline.
Pertussis in Pregnancy and Post-Partum	As per the discussion at the February 2013 NACI meeting, a brief pertussis statement has been drafted. The statement was presented to NACI for comments and feedback. NACI was asked to consider the development of a two pager which summarizes the statement. Further comments and NACI approval of the statement will be sought via email.
Statement: Update on the Use of Herpes Zoster Vaccine	Following the last review of the statement update by NACI, there were changes made in the recommendations of the statement. The revised recommendations were presented to NACI for comment/feedback. NACI members are to send in any additional comments following the meeting. The statement will be revised and sent to NACI for final approval via email.
Statement: Update on Human Papillomavirus (HPV) Vaccines	A summary of the recent NACI HPV working group meeting was provided. The working group meeting included two presentations on a 2-dose versus a 3-doses vaccine series. The working group would like to proceed with the evaluation of the evidence and the development of a statement update on a 2-dose series. The proposed HPV statement update will be assessed and prioritized as part of the overall NACI work plan items.
Biologics and Genetic Therapies Directorate (BGTD)	An overview was provided on the Canadian Regulatory process. Although there is a product monograph template, NACI members felt that the presentation of the information could be improved.
Liaison Representatives/Ex-officios Updates	Updates were provided by liaison representatives and ex-officio members including the: Association of Medical Microbiology and Infectious Disease Canada (AMMI), Canadian Association for Immunization Research and Evaluation (CAIRE), Canadian Immunization Committee (CIC), College of Family Physicians of Canada (CFPC), First Nations and Inuit Health Branch (FNIHB), Canadian Public Health Association (CPHA), Council of Chief Medical Officers of Health (CCMOH), Canadian Paediatrics Society (CPS), Centers for Disease Control and Prevention (CDC), College of Family Physicians of Canada, Department of National Defense and Canadian Forces, Marketed Health Products Directorate (Health Canada), Vaccine Safety Section (the Agency).
Ajournment	The Chair thanked members for their contributions and the meeting was adjourned.

February 2013

Summary of Discussion February 6-7, 2013 Meeting, Ottawa, Ontario
Agenda Item	Summary
Opening Remarks	The Chair, Dr. Bryna Warshawsky, welcomed participants to the meeting. New NACI member, Dr. Ian Gemmill was welcomed to the committee. New Liaison representative, Dr. Anne Pham-Huy from CAIRE was introduced and welcomed to NACI. She will be replacing Dr. Jason Brophy during his absence. New Ex-officio representatives, Dr. Carole Légaré from Marketed Biologicals, Biotechnology and Natural Health Products Bureau, Health Canada and Dr. Maureen Carew from First Nations and Inuit Health Branch, Health Canada were welcomed to NACI.
Canadian Immunization Guide (CIG) Planning	A status of the CIG revision was provided. Twenty-one of the Part 4 chapters are now web posted. Part 3 chapters are NACI approved and all Part 2 chapters are on the agenda for review during the meeting. Part 5 and 1 are the remaining chapters requiring NACI approval. An operational plan is being developed for the evergreen process. The management of ongoing updates and changes will be considered as part of the operational plan.
First review of CIG Chapter: Vaccine Administration Practices	This was NACI's first review of the Chapter. Members reviewed, discussed and resolved issues raised by the Working Group. The chapter will be revised to incorporate changes from this review and presented to NACI for 2nd/final review at the March 25, 2013 teleconference.
First Review of CIG Chapter: Timing of Vaccine Administration	This was NACI's first review of the Chapter. Members reviewed, discussed and resolved issues raised by the Working Group. The chapter will be revised and presented to NACI for 2nd/final review at the March 25, 2013 teleconference.
Second review of CIG Chapter: Vaccine Safety	This was NACI's second review of the Chapter. Issues which were previously raised by NACI and the Working Group have been resolved in consultation with the Biologics and Genetic Therapies Directorate (BGTD). The purpose of this review was to address new issues. Following todays review the chapter will be further reviewed by the designated Working Group and NACI reviewers and then sent to the Working Group and NACI Chair for approval.
Second review of CIG Chapter: Contraindications and Precautions	This was NACI's second review of the chapter. The purpose of the chapter is to orient the end user so they are able to find the information they need on contraindications and precautions. Following todays review the chapter will be further reviewed by the designated Working Group and NACI reviewers and then sent to the Working Group and NACI Chair for approval.
Second review of CIG Chapter: Early Vaccine Reactions including Anaphylaxis	This was NACI's second review of the chapter. Following incorporation of the changes suggested today, the chapter will be further reviewed by the designated Working Group and NACI reviewers and then sent to the Working Group and NACI Chair for approval.
Second review of CIG Chapter: Anaphylaxis hypersensitivity to egg chapter	This was NACI's second review of the chapter. Following incorporation of the changes suggested today, the chapter will be further reviewed by the designated Working Group and NACI reviewers and then sent to the Working Group and NACI Chair for approval.
Second review of CIG Chapter: Smallpox	This was NACI's second review of the chapter. Following incorporation of the changes suggested today, the chapter will be sent to the Working Group and NACI Chair for final approval.
First review of CIG Chapter: Tick-Borne Encephalitis	This was NACI's first review of the chapter. Members from the Committee to Advise on Tropical Medicine and Travel (CATMAT) participated in the Agenda Item via teleconference. The chapter will be revised and sent for second review and approval by email.
Vaccine Safety Working Group (VS WG)	The purpose of this item was to review and obtain comments on the working group's draft Terms of Reference (ToR). The draft ToR are to be updated as per NACI's feedback, and following these reviews and revisions, the document will be sent to the NACI-VSWG and the NACI Chair for further comments and approval.
Liaison Representative and Ex-officio Updates	Updates were provided by liaison representatives and ex-officio members including the: Association of Medical Microbiology and Infectious Disease Canada (AMMI), Canadian Association for Immunization Research and Evaluation (CAIRE), Canadian Immunization Committee (CIC), College of Family Physicians of Canada (CFPC), First Nations and Inuit Health Branch (FNIHB), Canadian Public Health Association (CPHA), Council of Chief Medical Officers of Health (CCMOH), Canadian Paediatrics Society (CPS), Centers for Disease Control and Prevention (CDC), College of Family Physicians of Canada, Biologics and Genetic Therapies Directorate (BGTD - Health Canada), First Nations and Inuit Health Branch (Health Canada), Marketed Biological, Biotechnology and Natural Health Products Bureau (Health Canada), Pandemic Preparedness Division, Centre for Immunization and Respiratory Infectious Diseases (PHAC), Vaccine Preventable Diseases, Centre for Immunization and Respiratory Infectious Diseases (PHAC).
NACI Statement: 2013-14 Seasonal Influenza Vaccine Interim Statement Swine and Poultry Workers	The Influenza Working Group (IWG) Chair provided additional background information on influenza vaccination and swine and poultry workers since the October 2012 NACI meeting in addition to options for inclusion of specific recommendations in the 2013-2014 statement. The Chair presented the 2013-2014 interim seasonal influenza statement. The timing of the influenza interim and full statements was discussed. The 2013-14 Interim statement will be adjusted as per the decisions made and a revised draft will be sent to NACI for final approval. The Working Group Chair presented the IWG ToR, which were recently revised based on the approved NACI ToR, for approval. The IWG ToR was approved and NACI members were advised to send any additional comments to the IWG chair following the meeting.
NACI Statement: Pertussis / Polio / Addressing the Quadracel^®Shortage	The focus of this Agenda Item was to update NACI on the progress of the statement update and to obtain general feedback on the current draft. The final statement, which will include the recommendations, is expected to be ready for NACI review and approval in March. The focus of the work group, as per the request from CCMOH, is on the pertussis and polio vaccine components and not specifically diphtheria or tetanus.
Pertussis - Potential approach to more timely NACI products	At the October 2013 meeting, NACI requested that the Pertussis Working Group consider the issues of vaccination in pregnancy, recommendations for and effectiveness of cocooning strategies and waning immunity in adolescents and adults. The priority issue for the working group is to review vaccination in pregnancy as this is the higher priority at this time. The working group will aim to have the first draft of the statement ready for the June meeting.
NACI Terms of Reference (TOR)	The Associate Director General informed the Committee that the updated NACI ToR has been approved by the Assistant Deputy Minister, Infectious Disease Prevention and Control Branch. Following the meeting, the selection process for the Vice-Chair will be initiated. As per the approved NACI ToR, the Vice-Chair will be appointed for a 2 years term with the potential for a one year extension.
General NACI Business	The Status Report on NACI Work Plan Activities was provided to members for their information.
Update on Meningococcal B Pilot Project	A status update on the Meningococcal B pilot project was provided. The updated literature review and the draft NACI statement and recommendations were presented to NACI. NACI members are to review and provide additional comments on the literature review and the draft statement following the meeting.
NACI Statement: Update on Herpes Zoster	The focus of this Agenda Item was to provide an update on work to date and to present a draft of the herpes zoster statement update for review and comment. The statement will be sent to NACI for a second review and approval via email following the meeting.
National Immunization Strategy (NIS)	The Associate Director General, Centre for Immunization and Respiratory Infectious Diseases provided an update on the Public Health Network review of the NIS.
Adjournment	The NACI Chair thanked members for their contributions and adjourned the meeting.

October 2012

Summary of Discussion October 3-5, 2012 Meeting, Ottawa, Ontario
Agenda Item	Summary
Opening Remarks	The Chair, Dr. Bryna Warshawsky, welcomed participants to the meeting. Dr. John Spika, Director General (DG), Centre for Immunization and Respiratory Infectious Diseases (CIRID), Public Health Agency of Canada, introduced the NACI team from CIRID.
Canadian Immunization Guide (CIG) Planning	Part 4, disease specific chapters of the Canadian Immunization Guide, are planned for release at the Canadian Immunization Conference, December 3-5, 2012 in Vancouver, BC. Following this, revised and new chapters will continue to be posted incrementally as they are completed.
CIG Wording for "No known allergies" (consistency issue across chapters)	Where applicable, Part 4 chapters will specify that there are no known allergens for specific vaccines. This will be applied to chapters is progress and will be revised in chapters already approved when they undergo future changes/updates.
First review of CIG Chapter: Chronic Diseases Chapter	The chapter was reviewed. Following discussion it was decided that further details/clarification should be provided on influenza immunization and specifically around the use of live attenuated influenza vaccine. The chapter will also need to clarify the best practices around intramuscular injections for patients with bleeding disorders or taking long-term anticoagulant therapy.
First Review of CIG Chapters: Typhoid	Members of the Committee to Advise of Tropical Medicine and Travel (CATMAT) participated in the discussion via teleconference. The chapter was reviewed and included a discussion on when typhoid vaccine is indicated for travellers. Following the discussion it was decided that further clarity is required around vaccine effectiveness in young children, minimum age for vaccination, decreased gastric secretions, antibiotics and the oral vaccine, and the time interval for boosting with the oral vaccine.
First Review of CIG Chapters: Travellers	Members of the Committee to Advise of Tropical Medicine and Travel (CATMAT) participated in the discussion via teleconference. The chapter was reviewed. The following items were discussed: measles vaccination for infants traveling to an endemic country, need to distinguish between an infant who is going to an endemic country and an infant who is in an endemic area and is coming to Canada, and the need to emphasize the increased risk for varicella with travel.
NACI Statement: 2013-14 Seasonal Influenza Vaccine Statement	Literature was presented on influenza vaccination and commercial swine and poultry workers. This item was added to the February NACI meeting agenda to allow further evidence to be gathered.
NACI Statement: Pneumo 13 Adult Indication	A preliminary review of the recommendations was completed with further discussions and review of the draft statement to occur following the meeting.
Liaison Representative and Ex-Officio Updates	Updates were provided by liaison members including the: Canadian Immunization Committee (CIC), Department of National Defence (DND), Health Canada's First Nations and Inuit Health Branch (FNIHB), Canadian Public Health Association (CPHA), Canadian Association for Immunization Research and Evaluation (CAIRE), Committee to Advise on Tropical Medicine and Travel (CATMAT), Council of Chief Medical Officers of Health (CCMOH), Association of Medical Microbiology and Infectious Diseases Canada (AMMI), Canadian Paediatrics Society (CPS), US Centers for Disease Control and Prevention (CDC), and Health Canada's Biologics and Genetic Therapies Directorate (BGTD).
Canadian Immunization Committee (CIC) Two-Dose Varicella Statement	The CIC sought NACI feedback on whether Canadian varicella recommendations would be impacted by a US article on universal varicella vaccination. It was decided that at this time there is no need to adjust the current NACI recommendations.
Zoster Vaccine and Low Dose Immunosuppressive Therapy	NACI currently recommends that herpes zoster vaccine should not be given to individuals taking most immunosuppressive medications, while ACIP has specific recommendations related to immunosuppressive medication which permits vaccination with herpes zoster vaccine when the patient is taking some low dose immunosuppressive agents. It was decided that an updated to the zoster statement should be completed and brought to the NACI February 2013 meeting. The update would review the issue of low dose immunosuppressive medication and zoster immunization, as well as vaccination following an episode of herpes zoster, herpes zoster ophthalmicus in those with a previous episode of herpes zoster ophthalmicus, and concomitant administration of herpes zoster vaccination and pneumococcal vaccine.
Pertussis Vaccination in Pregnancy	In 2011, ACIP made a recommendation on the use of pertussis-containing vaccines in pregnancy, with further discussion to take place at their upcoming October 2012 meeting. The NACI Pertussis Working Group is to consider the available evidence and the need for a NACI statement at this time.
NACI and CIC Statement: Meningococcal B Pilot Project	A presentation was provided to update NACI on the Meningococcal B Pilot Project. The pilot is still in its early stages so it is evolving. The pilot is being led by the Meningococcal B Task Group which reports to the Communicable and Infectious Disease Steering Committee (CID-SC) of the Public Health Network. As part of the pilot project, an evaluation will be completed and provided to CID-SC. A meeting with Ontario (PHO), Quebec (INSPQ) and PHAC occurred in August, with a meeting of the full Task Group project team being planned for this fall. The proposed plan is to have NACI review the burden of illness, efficacy/effectiveness and safety of the vaccine as per usual NACI process.
Meningococcal B Literature Review	A presentation was provided on a Meningococcal B literature review conducted by Public Health Ontario.
Issues Arising out of Quadracel^®Shortage	A CCMOH task group identified several questions related to longer-term issues surrounding the Quadracel^®shortage, which NACI was asked to review. A literature review and draft statement will be completed by NACI and provided to CCMOH.
First Review of Part 3 CIG chapters: Patients with Inadequate Records; New to Canada; and Healthcare Institutions	The chapter, Patients with Inadequate Records, was reviewed. Following revisions, including additional text on repeat immunizations, the chapter will be submitted for approval. The chapter, New to Canada, was reviewed. Following clarification/additional text on assessing HIV status prior to administration of live vaccines, TB skin testing and BCG vaccination, the global epidemiology of varicella, and vaccination for rubella, the chapter will be submitted for approval. The chapter, Healthcare Institutions, was reviewed. Following clarification/additional text on influenza vaccination and pregnancy, TB skin testing, avoidance of live vaccines during pregnancy, immunization of children in healthcare institutions according to age, the administration of live vaccines in health care settings, adverse event reporting, and pneumococcal vaccination in long term care facilities, the chapter will be submitted for approval.
Second Review of Part 3 Chapters: Immunocompromised	The chapter was reviewed. Following clarification/additional text on varicella and herpes zoster vaccination, vaccines contraindicated for those with B-cell deficiency and known intact T-cells, and influenza vaccination for those with an isolated IgA deficiency with no concomitant defects in T-cells, the chapter will be sent to NACI for final approval.
Second review of Part 3 CIG Chapters: Adults; and Workers	The Adults chapter was reviewed. Following clarification/additional text on PCV-13 (following completion of the statement on pneumococcal 13-valent vaccine for adults), the distinction between healthy adults at low risk and adults with risk factors, measles vaccination, and opportunistic immunization for polio, the chapter is to be submitted for approval. The Workers chapter was reviewed. Following clarification/additional text on polio vaccination and travel, influenza vaccination and healthcare workers, hepatitis B vaccination for workers in shelters for the homeless, varicella vaccination, and diphtheria and BCG vaccination for humanitarian relief workers, additional comments will be sought following the meeting.
Other CIG Updates: Anaphylaxis; BCG; and Pregnancy and Lactation	Status updates and outstanding issues were discussed including: administration of epinephrine in the Anaphylaxis chapter; TB skin testing in the BCG chapter; and consideration to changing the name of the Pregnancy and Lactation chapter.
Executive Summary	An update was provided on the status of the Terms of Reference, NACI work plan, Guidelines for Manufacturer Presentations to NACI and NACI Working Groups, and the joint NACI / CATMAT committee on developing evidence-based vaccine recommendations.
Improved National Structures and Processes for Making Immunization Recommendations (INSPIR) and the National Immunization Strategy Task Group (NIS-TG) Updates	The need for improved coordination and efficiencies and reduced duplication in the development of immunization recommendations was emphasized, as per the INSPIR report. NACI was also provided with an update on work to date of the NIS-TG.
Vaccine Industry Committee (VIC) Feedback on INSPIR Report Recommendations	Mr. John Dorsey, outgoing Chair of the Vaccine Industry Committee (VIC), introduced his colleagues and presented VIC's feedback on the INSPIR report recommendations. NACI and VIC discussed issues/solutions. VIC will take the issues raised by NACI back to the full committee to discuss and respond as necessary.

May 2012

Summary of Discussion May 23-25, 2012 Meeting, Ottawa, Ontario
Agenda Item	Summary
Please note that the NACI Statement on Seasonal Influenza Vaccine for 2012-2013 was approved during a teleconference prior to the May 23-25^th meeting.
Opening Remarks	The Chair, Dr. Bryna Warshawsky, welcomed participants to the meeting. The Committee was informed of the resignation of one member, the completion of two terms by another NACI member, and the departure of the Committee to Advise on Tropical Medicine and Travel liaison member. The contributions of these members were acknowledged. Dr. Rainer Engelhardt, the Assistant Deputy Minister (ADM), Infectious Disease Prevention and Control Branch, informed the Committee of the development of the Public Health Agency of Canada's policy on External Advisory Bodies. The policy was developed to ensure transparency and consistency in the approaches used by advisory bodies to provide advice to the Public Health Agency of Canada.
NACI Operational work plan	Resource needs and solutions to support NACI were discussed. There was a decision to develop a detailed operational plan, including resource requirements.
Common Evidence - Based Recommendation Framework	Dr. Ken Scott, the Chair of the Special Advisory Committee (SAC) on the Development of Evidence-Based Vaccine Recommendations (DEVR), provided an update on the committee's activities, which have been focused on completing environmental scans of evidence-based strategies used by other groups.
NACI Statement & Chapter Review Process	NACI review and approval processes were discussed for the Canadian Immunization Guide (CIG). Revised processes were established.
NACI Fall/Winter Teleconference Schedule	A fixed, bi-weekly teleconference schedule was agreed to in order to facilitate the review of the CIG chapters, and discuss other NACI items as required.
Terms of Reference (TOR)	The NACI Terms of Reference (TOR) are being revised so that they align with the Public Health Agency of Canada's policy on External Advisory Bodies. Following further considerations and potential revisions, the TOR will be brought back to NACI for review.
Update on the selection process for NACI Vice Chair	The process for the selection of the NACI Vice-Chair was discussed and will be reflected in the NACI TOR.
Meningococcal B Statement	A presentation was provided to inform NACI members about the progress of the working group to date. The literature review is expected to be ready for review by the working group in June. A draft statement will be brought forward to NACI at an upcoming meeting.
Pneumococcal 13 in Adults	An evidence review is in progress for PNEU-C- 13, including a review of the literature for adult subgroups. Evidence on the efficacy and safety of pneumococcal vaccines in individuals with transplants (liver, kidney, bone marrow, stem cell), persons with HIV infection, and in the elderly were reviewed and discussed. A statement will be prepared by the Working Group for NACI review. Data on the immunization of asthmatic individuals for the prevention of invasive pneumococcal disease (IPD) was also presented.
Improved National Structures and Processes for making Immunization Recommendations (INSPIR) and National Immunization Strategy- Task Group	The NIS-TG is assessing the mechanisms and processes for the development of immunization statements in Canada. The Meningococcal B statement was identified as a pilot project.
Liaison Member Updates	Updates were provided by Liaison members including: the Canadian Immunization Committee, Department of National Defence, Health Canada's First Nations and Inuit Health Branch, College of Family Physicians of Canada, Canadian Public Health Association, US Advisory Committee on Immunization Practices, Canadian Association for Immunizations Research and Evaluation, Committee to Advise on Tropical Medicine and Travel Health, Council of Chief Medical Officers of Health, Association of Medical Microbiology and Infectious Diseases Canada and Canadian Paediatric Society.
Exacerbation of Herpes Zoster Ophthalmicus following Zoster virus vaccination	A presentation summarizing available information was provided. It was decided that an updated Herpes Zoster statement should be prepared to provide an update on information on herpes zoster ophthalmicus following vaccination in those with previous herpes zoster ophthalmicus. The frequently asked question, when to give zoster vaccine to those who want it after an episode of zoster, was also discussed. Based on expert opinion, it was decided that if vaccination is given after zoster, an interval of a year is recommended. In addition to including this in the updated statement, it will need to be included in the CIG.
CIG: Meningococcal Chapter	Following a discussion of booster doses for high-risk groups and re-vaccination following an exposure or during an outbreak situation, the chapter was revised and approved by NACI.
CIG: HPV Chapter	Vaccination of the following groups/indications was discussed: girls and women, boys and men, immunization after the onset of sexual activity and during breastfeeding. Following discussion and voting by NACI members, the chapter was approved with changes.
CIG: Immunocompromised Persons Chapter	This was the first review of the chapter by NACI. The following topics were discussed: Isolated IgA deficiency and live vaccines, dosing for Human papillomavirus vaccine, Hepatitis B virus vaccine, and immunosuppressive medications. All NACI WG chairs were asked to check for consistency with their specific chapter. The immunocompromised chapter will be revised based on input from the meeting and will be presented to NACI for final review this fall.
CIG: Hepatitis A Chapter	Discussion included risk factors, yeast protein, haemophilia, and travel-related vaccinations. The chapter was approved with the changes.
CIG: Hepatitis B Chapter	Discussion included the assessment of hepatitis B immune status, and the timing of administration of Hepatitis B immunoglobulin following sexual contact and needlestick injuries. The chapter was approved with changes.
Vaccine Safety Working Group	NACI reviewed and discussed the roles of different committees working on vaccine safety-related issues. A NACI Vaccine Safety Working Group was proposed and feedback was provided on a draft Terms of Reference (TOR). Following approval of the revised NACI Terms of Reference, the Vaccine Safety Working Group TOR will be revisited.
CIG: Vaccine Schedules	The immunization tables in the chapter were reviewed, with specific issues discussed for: Table 1: Routine Immunization Schedule for Infants and Children; Table 2: Routine Immunization Schedule for Children less than 7 Years Not Previously Immunized; Table 3: Routine Immunization for Children > 7 Years of Age up to 17 Years; Table 4: Immunization Schedule for Children at Risk; Table 5: Adults Not Previously Immunized; Table 6: Adults Previously Immunized - Additional Doses; and Table 7: Adults at Risk. Following revisions to the tables they will be sent to NACI members for review.
CIG: Chronic Disease Chapter	Discussion included the scope and depth of the chapter, and the list of chronic conditions to be included. The chapter will be revised based on the discussion and a new version will be sent to NACI for review this fall.
CIG: Rotavirus Chapter	Discussion included the timing of doses and intussusception. The chapter was approved by NACI with changes.
Guidelines for Manufacturer Presentations to NACI and NACI Working Groups	A presentation was provided on the revised Guidelines for Manufacturer Presentations to NACI and NACI Working Groups. Issues identified by the Vaccine Industry Committee were discussed. Following additional changes, based on the items discussed during the meeting, the Guidelines will be sent for approval within the Public Health Agency of Canada.

February 2012

Summary of Discussion February 8-10, 2012 Webex Meeting, Ottawa, Ontario
Agenda Item	Summary
National Immunization Strategy Task Group (NISTG) - Improved National Structures and Processes for Making Immunization Recommendations (INSPIR)	The Immunization Director, Danielle Poulin, advised members that the recommendations of the INSPIR report will be considered in the context of the NISTG recommendations anticipated on or before July 2013. However, the NISTG target date to implement outcomes of the INSPIR and NISTG strategy is unknown at this time. There are many strategies being considered - some that may affect the spectrum of factors that NACI will be expected to consider when making evidence-based recommendations.
Influenza Literature Review, Draft Interim Statement & Full Statement on Seasonal Influenza Vaccine for 2012-13	The NACI Influenza Working Group is actively working on a literature review of healthy children 24-59 months of age. The literature review will inform the 2012-13 statement with the inclusion of healthy children 24-59 months as recommended recipients of the seasonal influenza vaccine. The draft Interim Statement is in progress and the e-version is anticipated to be ready for distribution to stakeholders by February 17, 2012 to inform vaccine procurement and programs for 2012-13. The full statement is expected to be posted on the Public Health Agency of Canada (PHAC) web site in the summer of 2012. A draft will be presented to NACI in May 2012.
Meningococcal B Statement	The NACI Meningococcal Working Group has met by teleconference. They have received presentations from PHAC and some provinces regarding epidemiology, as well as a presentation on a candidate vaccine. They are scheduled to meet several times this winter/spring to discuss and work on statement development. A literature review is planned.
Canadian Immunization Guide (CIG): Meningococcal Chapter	The draft Meningococcal Chapter was reviewed. The key issues discussed were: Recommendations and schedules for high risk children and adults, including the need for booster vaccination; Re-vaccination of contacts of cases; Whether those with HIV should be included in the high risk group; and Vaccination of infants. The Meningococcal chapter has been consistency checked and a chronic disease section has been included. The working group met on January 16, 2012 and the subsequent revised draft has been reviewed by the Working Group Chair. The NACI Meningococcal Working Group will make relevant revisions in the NACI Statement Update on Conjugate Quadrivalent Meningococcal Vaccines (already reviewed and approved by NACI) and will circulate these changes to NACI for final review upon Working Group approval.
Canadian Immunization Guide: Bacille Calmette-Guérin (BCG) Chapter	The draft BCG chapter was reviewed. A PHAC tuberculosis expert will review the chapter.
Canadian Immunization Guide: The Human Papillomavirus (HPV) Chapter	The draft HPV chapter was reviewed.
CIG Progress and Update	The schedule for the remainder of the Part 4 Chapters was presented to NACI. Although ambitious, NACI agreed to the schedule due to the importance of these chapters to healthcare providers in Canada. In the meantime, work has begun on the Immunocompromised and Chronic Diseases Chapters in Part 3. A plan for completion of the guide will be presented at the NACI meeting in May 2012.
NACI Statement Products	The NACI Executive Secretary presented a proposal for NACI products which include: 1) Literature Reviews 2) Interim Statements; 3) NACI Statements; and 4) NACI Statement Updates. The products are intended to share NACI recommendations with stakeholders with differing needs in a timely and user friendly way. An in depth description of each product, timelines for release, and target audiences was presented. It was noted that the Canadian Immunization Guide will be maintained as an evergreen document by incorporating changes as they arise from these NACI products. There was a suggestion to ensure products are flexible enough to accommodate new indications for old vaccines as well as new vaccines.
Evidence-Based Recommendations	A subcommittee for Developing Evidence-based Vaccine Recommendations (DEVR) has been formed to develop options for a common approach for developing evidence-based vaccine recommendations. This sub-committee is chaired by Dr. Ken Scott, Senior Medical Advisor to the Assistant Deputy Minister of The Infectious Disease Prevention and Control Branch, and includes membership from NACI and the Committee to Advise on Tropical Medicine and Travel (CATMAT). The expected outcomes of this group are that: 1) Evidence-based immunization recommendations from PHAC's expert advisory committees on immunization should reflect the advances in evidence-based medicine and take into account any resource implications associated with these approaches, and 2) The subcommittee will develop and present options and recommendations for the revision of the processes to develop evidence-based immunization recommendations to be reviewed and discussed by NACI and CATMAT. It was confirmed that NACI and CATMAT will be kept informed of the progress of the subcommittee, and proposed changes to current processes will be discussed with the committees before any changes are made.
Liaison Member Update	The Canadian Association for Immunization Research and Evaluation (CAIRE) has held recent meetings in Ottawa relevant to NACI. At a two-day education session regarding education of vaccine providers, there was discussion as to how NACI statements could better serve end users. At a one-day meeting entitled "Smoothing the Path to New Vaccine Development", various stakeholders including PHAC, the Biologics and Genetic Therapies Directorate (BGTD), provinces, CAIRE, and industry came together to identify how to improve collaboration and smooth the pathway for new vaccines. Summary reports of both meetings are being prepared. Finally, CAIRE will host a 'Vaccine Science Day' prior to the beginning of the Canadian Immunization Conference in December, highlighting Canadian vaccine research. Canadian Paediatric Society (CPS) The HPV statement will be updated to include a recommendation for vaccination of boys. The FluMist and Influenza vaccine notes will be updated when the NACI statement is available. The Canadian Public Health Association (CPHA) The CPHA annual meeting for 2012 is June 11-14 in Edmonton. There will be an environmental theme but there are immunization sessions in the program as well that may be of interest. In addition, the Immunization Competencies Education Program, sponsored by CPS, was held in Banff in early December 2011. This workshop teaches medical residents and other health professionals about immunization competencies, based on the PHAC document. It is a good way to develop young health professionals as ambassadors for immunization. CPS subsidized the program heavily this year, and it may not be able to continue without unrestricted educational grants from government or other sources. The Committee to Advise on Tropical Medicine and Travel (CATMAT) is currently working on revising the Evidence Based Medicine process and the Typhoid Statements (using a systematic review process based on GRADE). CATMAT continues to review Canadian Immunization Guide chapters related to travel as they are revised. The Canadian Immunization Committee (CIC) is currently working on the Rotavirus, Herpes Zoster, 2-dose Varicella, and Human Papillomavirus statements. These may be the last statements developed by CIC.
Wrap up and Future NACI Meetings	The next NACI meeting is scheduled for May 23-25, 2012. A teleconference focused on the influenza statement is scheduled for May 1, 2012 at 1 p.m. Eastern time. The fall NACI meeting is tentatively scheduled for October 3-4, 2012. Additional meetings are scheduled for the following dates: February 6-7, 2013 June TBC, 2013 Oct TBC, 2013

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