Drug and vaccine authorizations for COVID-19: List of applications received

Date published: 2024-01-19

Under the interim order, a company could submit an application for a drug or vaccine for use in COVID-19 that:

The Interim order expired September 16, 2021 so all new submissions will now be filed under the Food and Drug Regulations.

The list below includes all applications received by Health Canada for drugs and vaccines used for the COVID-19 pandemic. This list includes applications received under the interim order and those received under the Food and Drug Regulations. The current status of each application is also noted.

Information for each application includes the:

In the "outcome of application" column, there are 5 possible scenarios:

The authorization dates below refer to decisions made under the interim order (IO) or the Food and Drug Regulations (FDR). Authorization of new uses (for example, pediatric use) and their authorization dates are also included.

Consult the Drug and health product submissions under review (SUR) list and the Generic submissions under review list to access submissions under review that are not related to the COVID-19 pandemic.

Applications received related to the COVID-19 pandemic
Applicant Medicinal ingredient(s) Therapeutic area Date application was received Outcome of application Date of decision/outcome
BioNTech Manufacturing GmbH Raxtozinameran Vaccines, for human use 2023-06-29 Authorized (with terms and conditions) 2023-09-28 (FDR)
Moderna Biopharma Canada Corporation Andusomeran Vaccines, for human use 2023-06-29 Authorized (with terms and conditions) 2023-09-12 (FDR)
AstraZeneca Canada Inc Adenovirus vaccine vector (ChAdOx1-S [recombinant]) Vaccines, for human use 2020-10-01 Authorized (with terms and conditions)

2021-02-26 (IO)

2021-11-19 (FDR)

AstraZeneca Canada Inc Adenovirus vaccine vector (ChAdOx1-S [recombinant]) Vaccines, for human use 2021-12-10 First booster dose – Cancelled by sponsor

2022-03-31 (FDR)

AstraZeneca Canada Inc Cilgavimab and tixagevimab Immune sera and immunoglobulins, for human use 2021-11-03 Authorized (with terms and conditions)

2022-04-14 (FDR)

2022-10-18 (Expanded indication, FDR)

Celltrion HealthCare Co Ltd Regdanvimab Immune sera and immunoglobulins, for human use 2021-05-21 Under review n/a
Eli Lilly Canada Inc Bamlanivimab (LY-CoV555) Immune sera and immunoglobulins, for human use 2020-10-12

Authorized (with terms and conditions)

Cancelled by sponsor

2020-11-20 (IO)

2023-02-20 (Cancelled, FDR)

Gilead Sciences Canada Inc Remdesivir Antivirals for systemic use, for human use 2020-06-19 Authorized (with conditions)

2020-07-27 (FDR)

2022-04-22 (Expanded indication, FDR)

2023-06-15 (ages older than 28 days-11 years, FDR)

Moderna Biopharma Canada Corporation Elasomeran Vaccines, for human use 2020-10-12 Authorized (with terms and conditions)

2020-12-23 (IO)

2021-08-27 (ages 12-17 years, IO)

2021-09-16 (FDR)

2021-11-12 (First booster dose, FDR)

2022-03-17 (ages 6-11 years, FDR)

2022-07-14 (ages 6 months-5 years, FDR)

2023-01-12 (First booster dose, ages 12-17 years, FDR)

Moderna Biopharma Canada Corporation Elasomeran Vaccines, for human use 2022-04-01 Second booster dose – Cancelled by sponsor 2022-09-16 (FDR)
Moderna Biopharma Canada Corporation Elasomeran, imelasomeran Vaccines, for human use 2022-06-30 Authorized (with terms and conditions)

2022-09-01 (Bivalent booster, ages 18 years and over, FDR)

2023-02-17
(Bivalent booster, ages 6-17 years, FDR)

Moderna Biopharma Canada Corporation Elasomeran, davesomeran Vaccines, for human use 2022-09-12 Authorized (with terms and conditions)

2022-11-03 (Bivalent booster, ages 18 years and over, FDR)

2023-05-18 (Booster dose, ages 6-17 years, FDR)

Novavax Inc. SARS-CoV-2 recombinant spike protein Vaccines, for human use 2021-01-29 Authorized (with terms and conditions)

2022-02-17 (FDR)

2022-11-17 (First booster dose, FDR)

2022-12-06 (Adolescent dose, ages 12-17 years, FDR)

Moderna Biopharma Canada Corporation Elasomeran, davesomeran Vaccines, for human use 2023-04-26 Cancelled by sponsor 2023-10-26 (FDR)
Novavax Inc. SARS-CoV-2 recombinant spike protein Vaccines, for human use 2023-03-15 Cancelled by sponsor 2023-11-09 (FDR)
Novavax Inc. SARS-CoV-2 recombinant spike protein (Omicron XBB.1.5) Vaccines, for human use 2023-09-01 Authorized (with terms and conditions) 2023-12-05 (FDR)
Pfizer Canada ULC/BioNTech SE Tozinameran (mRNA vaccine, BNT162b2) Vaccines, for human use 2020-10-09 Authorized (with terms and conditions)

2020-12-09 (IO)

2021-05-05 (ages 12-15 years, IO)

2021-09-16 (FDR)

2021-11-09 (First booster dose, FDR)

2021-11-19 (ages 5-11 years, FDR)

2022-06-01 (First booster dose ages 16-17 years, FDR)

2022-08-19 (First booster dose ages 5-11 years, FDR)

2022-09-09 (ages 6 months-5 years, FDR)

Pfizer Canada ULC/BioNTech SE Tozinameran, riltozinameran Vaccines, for human use 2022-07-25 Authorized (with terms and conditions) 2022-10-21 (Bivalent booster, ages 12 years and over, FDR)
Pfizer Canada ULC/BioNTech SE Tozinameran, famtozinameran Vaccines, for human use 2022-09-02 Authorized (with terms and conditions)

2022-10-07 (Bivalent booster, ages 12 years and over, FDR)

2022-12-09 (Bivalent booster, ages 5-11 years, FDR)

2023-07-06 (Primary series, ages 5 years and over, FDR)

2023-08-31 (Primary series, ages 6 months to < 5 years, FDR)

Janssen Inc Ad26.COV2.S (recombinant) Vaccines, for human use 2020-11-30 Authorized (with terms and conditions)

2021-03-05 (IO)

2021-11-23 (FDR)

2022-05-11 (First booster dose, FDR)

Dr Reddys Laboratories Ltd Favipiravir Antivirals for systemic use, for human use 2020-12-18 Cancelled by sponsor 2022-02-24 (FDR)
Pendopharm Division of Pharmascience Inc ColchicineFootnote * Antigout preparations, for human use 2021-01-25 Cancelled by sponsor 2021-06-07 (IO)
Verity Pharmaceuticals Inc/Serum Institute of India (in partnership with AstraZeneca Canada Inc) Adenovirus vaccine vector
(ChAdOx1-S [recombinant])
Vaccines, for human use 2021-01-23

Authorized (with terms and conditions)

Expired

2021-02-26 (IO)

2021-09-16
(expired)

Eli Lilly Canada Inc Bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) Immune sera and immunoglobulins, for human use 2021-02-16 Cancelled by sponsor 2023-02-20 (FDR)
Hoffmann-La Roche Limited Casirivimab and imdevimab Immune sera and immunoglobulins, for human use 2021-02-24 Authorized (with conditions) 2021-06-09 (IO)
Hoffmann-La Roche Limited TocilizumabFootnote * Immonusuppressants, for human use 2022-02-04 Authorized 2022-10-13 (FDR)
CytoDyn, Inc. Leronlimab Immune sera and immunoglobulins, for human use 2021-03-23 Expired 2021-09-16
GlaxoSmithKline Inc Sotrovimab Immune sera and immunoglobulins, for human use 2021-04-01 Authorized (with conditions) 2021-07-30 (IO)
Medicago Inc Virus-like particles (VLP) of SARS-CoV-2 spike protein Vaccines, for human use 2021-04-19 Authorized (with terms and conditions)

2022-02-24 (FDR)

2023-03-30 (ages 65 years and older, FDR)

Merck Canada Inc Molnupiravir Antivirals for systemic use, for human use 2021-08-13 Cancelled by sponsor 2023-04-26 (FDR)
Eli Lilly Canada Inc BaricitinibFootnote * Antivirals for systemic use, for human use 2021-05-13 Issued Notice of Non-compliance – Withdrawal 2023-06-13 (FDR)
Pfizer Canada ULC Nirmatrelvir and ritonavir Antivirals for systemic use, for human use 2021-12-01 Authorized (with terms and conditions) 2022-01-17 (FDR)
Sanofi Pasteur Limited SARS-CoV-2 prefusion spike delta TM protein, recombinant Vaccines, for human use 2021-07-21 Cancelled by sponsor 2023-02-27 (FDR)
Sanofi Pasteur Limited SARS-CoV-2 prefusion spike delta TM protein, recombinant Vaccines, for human use 2022-12-16 Cancelled by sponsor 2023-01-25 (FDR)
Sanotize Research & Development Corp. Nitric oxideFootnote * Other nervous system drugs, for human use 2021-06-15 Cancelled by sponsor 2021-09-01 (IO)
Vaccigen Ltd Whole virion inactivated corona virus Vaccines, for human use 2021-06-30 Cancelled by sponsor 2022-08-26 (FDR)
Veru Inc. Sabizabulin Antivirals for systemic use, for human use 2022-11-24 Cancelled by sponsor 2023-06-08 (FDR)
Footnote *

This product is approved in Canada for other uses.

Return to footnote * referrer

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