Licensed vaccine
Comirnaty
FDA-licensed vaccine · BioNTech Manufacturing GmbH · STN 125742
Key facts
| Trade name | Comirnaty |
|---|---|
| Proper name | COVID-19 Vaccine, mRNA |
| Manufacturer | BioNTech Manufacturing GmbH |
| Submission tracking number (STN) | 125742 |
| FDA product areas | Biologics |
| Recent FDA documents | October 10, 2024 Approval Letter - COMIRNATY, August 28, 2024 Approval Letter - COMIRNATY, December 6, 2023 Approval Letter - COMIRNATY, October 17, 2023 Approval Letter - COMIRNATY, September 22, 2023 Approval Letter - COMIRNATY, Statistical Review - COMIRNATY, September 11, 2023 Clinical Review Memo - COMIRNATY, Comirnaty (COVID-19 Vaccine, mRNA), September 11, 2023 Approval Letter COMIRNATY, April 20, 2023 Approval Letter COMIRNATY, August 25, 2022 Approval Letter - COMIRNATY, July 8, 2022 Clinical Review Memo - COMIRNATY |
| FDA page updated | Oct 11, 2024 |
| FDA product page | fda.gov |
At a glance
- 10–99 FDA approval letters
- 10–99 Supporting documents
- 1–9 Product information documents
- Yes Document full text searchable in Orca1
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-licensed vaccines
The FDA's CBER licenses vaccines for use in the United States. Each product page links the approval letters, package inserts and supporting documents for that vaccine.
Source: U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Vaccines Licensed for Use in the United States · Source date: