Drug and vaccine authorizations for COVID-19: List of applications received
Date published: 2023-12-05
Under the interim order, a company could submit an application for a drug or vaccine for use in COVID-19 that:
- had never been approved in Canada
- had previously been approved in Canada for another use
- had been approved by a trusted foreign regulatory authority
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:
- applicant (name of the company that submitted the application)
- medicinal ingredient(s)
- therapeutic area (using the World Health Organization's coding system)
- date we received the application
- outcome of the application
- date of outcome ("not applicable" means the application is still in progress)
In the "outcome of application" column, there are 5 possible scenarios:
- Under review
- Authorized
- Expired (by expiry of interim order)
- Rejected (by Health Canada)
- Cancelled (by the company)
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.
| 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 |
| 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 | Primary series, ages 6 months-11 years and booster dose, ages 6 months-5 years – Under review | n/a |
| Novavax Inc. | SARS-CoV-2 recombinant spike protein | Vaccines, for human use | 2023-03-15 | Booster dose, ages 12-17 years – Under review | n/a |
| 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 |
| 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)
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