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) |