Comirnaty and Pfizer-BioNTech COVID-19 Vaccine
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 5 years of age and older, for the administration of a third dose in certain immunocompromised people, and for a single booster dose in people:
- 65 and older
- 18 through 64 at high risk of severe COVID-19
- 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.
On October 20, 2021, the FDA authorized the use of a heterologous (or “mix and match”) booster dose in eligible populations with currently available (i.e., FDA-authorized or approved) COVID-19 vaccines. Therefore, Pfizer-BioNTech COVID-19 vaccine recipients falling into one of the authorized categories for boosters may receive the Moderna COVID-19 Vaccine (half dose), Pfizer-BioNTech COVID-19 Vaccine or Janssen COVID-19 Vaccine and should be given at least six months after completing the primary vaccination.
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) | October 20, 2021 |
Pfizer-BioNTech Fact Sheets (English) and FAQs
| Fact Sheet / FAQs | Vaccine Recipient Group | Last Updated |
|---|---|---|
| For Healthcare Providers | 12 years of age and older, purple cap (must dilute) | October 29, 2021 |
| For Healthcare Providers | 12 years of age and older, gray cap (no dilution) This formulation is not yet available in the United States. | October 29, 2021 |
| For Healthcare Providers | 5 - 11 years of age, orange cap (must dilute) | October 29, 2021 |
| For Recipients and Caregivers | 12 years of age and older | October 29, 2021 |
| For Recipients and Caregivers | 5 - 11 years of age | October 29, 2021 |
| Frequently Asked Questions on the Pfizer-BioNTech COVID-19 Vaccine | All | October 4, 2021 |
Pfizer-BioNTech Regulatory Information
| Information | Date |
|---|---|
| Letter of Authorization (Reissued) | October 29, 2021 |
| Advisory Committee Meeting Information | October 26, 2021 |
| Decision Memorandum | October 20, 2021 |
| Decision Memorandum | September 24, 2021 |
| Advisory Committee Meeting Information | September 17, 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 | October 29, 2021 |
| Press Conference | October 29, 2021 |
| Advisory Committee Webcast | October 26, 2021 |
| Press Release | October 20, 2021 |
| Media Call | October 20, 2021 |
| Press Release | September 22, 2021 |
| Advisory Committee Webcast | September 17, 2021 |
| 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
| Fact Sheet | Language |
|---|---|
| 接受者和护理者须知 (October 20, 2021) |
中文 (Chinese, Simplified) |
| 환자와 의료진을 위한 정보지 (October 20, 2021) |
한국어 (Korean) |
| HOJA INFORMATIVA PARA RECEPTORES Y PROVEDORES DE CUIDADO (October 20, 2021) |
Español (Spanish) |
| FACT SHEET PARA SA MGA TATANGGAP AT TAGAPAG-ALAGA (October 20, 2021) |
Tagalog (Tagalog) |
| TỜ THÔNG TIN CHO NGƯỜI NHẬN VÀ NHỮNG NGƯỜI CHĂM SÓC (October 20, 2021) |
Tiếng Việt (Vietnamese) |