Pfizer-BioNTech COVID-19 Vaccine
On August 27, 2025, the Food and Drug Administration revoked the emergency use authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine. Comirnaty (COVID-19 Vaccine, mRNA), manufactured by Pfizer Inc., is approved for use by FDA.
Pfizer-BioNTech COVID-19 Fact Sheets and Materials
| Material | Audience | Last Updated |
|---|---|---|
| Fact Sheet | Recipient and Caregiver | June 25, 2025 |
| Fact Sheet | Healthcare Provider | June 25, 2025 |
Pfizer-BioNTech Regulatory Information (Emergency Use Authorization)
| Information | Date |
|---|---|
| Revocation Letter | August 27, 2025 |
| Revocation Memorandum | August 27, 2025 |
| Granting Letter | June 25, 2025 |
| Granting Letter | December 8, 2023 |
| Concurrence Letter | November 15, 2023 |
| Decision Memorandum | August 22, 2024 |
| Letter of Authorization (Reissued) | August 22, 2024 |
Federal Register Notices
Translations of the Fact Sheet for Recipients and Caregivers