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  1. Coronavirus Disease 2019 (COVID-19)

Comirnaty and Pfizer-BioNTech COVID-19 Vaccine

October 20, 2021: The FDA expands authorizations for COVID-19 vaccine booster doses for eligible populations who received the Pfizer-BioNTech or Moderna COVID-19 Vaccine and for Janssen COVID-19 Vaccine recipients 18 and older.  View more information and listen to the media call.

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 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) August 23, 2021

 

Pfizer-BioNTech Fact Sheets (English) and FAQs

Pfizer-BioNTech Regulatory Information

Information Date
Decision Memorandum October 20, 2021
Letter of Authorization (Reissued) October 20, 2021
Decision Memorandum September 24, 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 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

At this time, the FDA is able to provide translations of the Pfizer-BioNTech COVID-19 Vaccine Fact Sheets for Recipients and Caregivers in the languages below. If you have a special language request, please contact: fdaoma@fda.hhs.gov.

Fact Sheet Language
接受者和护理者须知
(September 22, 2021)
中文 (Chinese, Simplified)
환자와 의료진을 위한 정보지
(September 22, 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
(September 22, 2021)
Tagalog (Tagalog)
TỜ THÔNG TIN CHO NGƯỜI NHẬN VÀ NHỮNG NGƯỜI CHĂM SÓC
(September 22, 2021)
Tiếng Việt (Vietnamese)
QABUL QILUVCHILAR VA PARVARISH QILUVCHILAR UCHUN COMIRNATY
(September 22, 2021)
Uzbeck (Uzbeck)

 

 

 

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