Comirnaty and Pfizer-BioNTech COVID-19 Vaccine
August 23, 2021: FDA approves Comirnaty (COVID-19 Vaccine, mRNA), which was previously known as Pfizer-BioNTech COVID-19 Vaccine, for the prevention of COVID-19 disease in individuals 16 years of age and older. View Comirnaty information, press release and frequently asked questions.
On August 23, 2021, the FDA approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
Comirnaty Information
| Information | Last Updated |
|---|---|
| Package Insert | August 23, 2021 |
| Summary Basis for Regulatory Action | August 23, 2021 |
| Approval Letter | August 23, 2021 |
| FAQ for Comirnaty (COVID-19 Vaccine mRNA) (Español) | August 23, 2021 |
Pfizer-BioNTech Fact Sheets (English) and FAQs
| Information | Last Updated |
|---|---|
| Fact Sheet for Healthcare Providers Administering Vaccine | August 23, 2021 |
| Fact Sheet for Recipients and Caregivers | August 23, 2021 |
| Frequently Asked Questions on the Pfizer-BioNTech COVID-19 Vaccine | August 23, 2021 |
Pfizer-BioNTech Regulatory Information
| Information | Date |
|---|---|
| Letter of Authorization (Reissued) | August 23, 2021 |
| Concurrence Letter | August 22, 2021 |
| Decision Memorandum | August 12, 2021 |
| Letter Granting EUA Amendment | May 19, 2021 |
| FDA Decision Memorandum | May 10, 2021 |
| Letter Granting EUA Amendment | April 6, 2021 |
| Letter Granting EUA Amendment | January 22, 2021 |
| Letter Granting EUA Amendment | January 6, 2021 |
| FDA Decision Memorandum | December 11, 2020 |
| Advisory Committee Meeting Information | December 10, 2020 |
Media Materials and Webcasts
| Information | Date |
|---|---|
| Press Release | August 23, 2021 |
| Press Release | August 12, 2021 |
| FDA In Brief | May 19, 2021 |
| Press Release | May 10, 2021 |
| Press Conference | May 10, 2021 |
| Press Release | February 25, 2021 |
| Press Release | December 11, 2020 |
| Press Conference | December 11, 2020 |
| Advisory Committee Webcast | December 10, 2020 |
Translations of the Pfizer-BioNTech Fact Sheet for Recipients and Caregivers