Table 1. COVID-19 Vaccine Approval by Regulatory Agency.
| COVID-19 Vaccine | US Food and Drug Administration | European Medicines Agency | Health Canada | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Submission date | Authorization datea | Time for review, (d) | Submission date | Authorization dateb | Time for review, (d) | Submission date | Authorization datec | Time for review, (d) | |
| Pfizer-BioNTech (BNT162b2) | 11/20/2020 | 12/11/2020 | 21 | 11/30/2020 | 12/21/2020 | 21 | 10/09/2020 | 12/09/2020 | 61 |
| Moderna (mRNA-1273) | 11/30/2020 | 12/18/2020 | 18 | 11/30/2020 | 01/06/2021 | 37 | 10/12/2020 | 12/23/2020 | 72 |
| Janssen (Ad26.COV2.S) | 02/04/2021 | 02/27/2021 | 23 | 02/16/2021 | 03/11/2021 | 23 | 11/30/2020 | 03/05/2021 | 95 |
| Oxford or AstraZeneca (ChAdOx1) | NA | NA | NAd | 01/11/2021 | 01/29/2021 | 18 | 10/01/2020 | 02/26/2021 | 148 |
| Median review time, (range), d | 21 (18-23) | 22 (18-37) | 84 (61-148) | ||||||
Abbreviation: NA, not applicable.
a
Vaccine approved under Emergency Use Authorization.
b
Vaccine approved under Conditional Marketing Authorization.
c
Vaccine authorized with specific terms and conditions.
d
Vaccine not approved.