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  1. Coronavirus Disease 2019 (COVID-19)

Pfizer-BioNTech COVID-19 Vaccines

Comirnaty and Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent

August 31, 2022: FDA authorizes updated COVID-19 vaccine boosters. View press releasepress conference and COVID-19 Bivalent Vaccine Boosters webpage

On August 23, 2021, FDA announced the first approval of a COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and the approved vaccine is marketed as Comirnaty, for the prevention of COVID-19 in individuals 12 years of age and older. 

Comirnaty is a monovalent COVID-19 vaccine that is approved for use as a two-dose primary series for the prevention of COVID-19 in individuals 12 years of age and older. It is also authorized for emergency use to provide a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. 

Pfizer-BioNTech COVID-19 Vaccine is a monovalent COVID-19 vaccine that is authorized for emergency use to prevent COVID-19 as a: 

  • Three-dose primary series for individuals 6 months through 4 years of age. 
  • Two-dose primary series for individuals 5 years of age and older. 
  • Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. 
  • Single booster dose for individuals 5 through 11 years of age at least five months after completing a primary series of the Pfizer-BioNTech COVID-19 Vaccine. 

Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for use to prevent COVID-19 in individuals 12 years of age and older as a single booster dose administered at least 2 months after either: 

  • Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or 
  • Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. 

On February 11, 2022, in consultation with FDA, CDC updated the emergency use instructions to provide information about the primary, additional, and booster doses of the Pfizer COVID-19 vaccines in certain individuals.


Comirnaty Information

Information Last Updated
Package Insert (purple cap) July 8, 2022
Package Insert (gray cap) July 8, 2022
Regulatory Information August 25, 2022
FAQ for Comirnaty (COVID-19 Vaccine mRNA) (Español) February 8, 2022
CDC-issued Emergency Use Instructions (updated) February 11, 2022

 

Pfizer-BioNTech Fact Sheets (English) and FAQs

Material Audience Vaccine Purpose Vaccine Recipient Group Last Updated
Pfizer-BioNTech COVID-19 Vaccine Presentations Wall Chart Healthcare Providers Bivalent Booster All August 31, 2022
Dear Healthcare Provider Letter Healthcare Providers Bivalent Booster 12 years of age and older August 31, 2022
Fact Sheet Healthcare Providers Primary Series 6 months through 4 years, maroon cap (must dilute) August 31, 2022
Dear Healthcare Provider Letter Healthcare Providers Primary Series 6 months through 4 years, maroon cap (must dilute) June 17, 2022
Fact Sheet Recipients and Caregivers Primary Series 6 months through 4 years of age June 28, 2022
Fact Sheet Healthcare Providers Primary Series and Booster 5 years through 11 years of age, orange cap (must dilute) August 31, 2022
Fact Sheet Recipients and Caregivers Primary Series and Booster 5 years through 11 years of age June 28, 2022
Fact Sheet Healthcare Providers Primary Series 12 years of age and older, purple cap (PBS formulation, must dilute) August 31, 2022
Fact Sheet Healthcare Providers Primary Series 12 years of age and older, gray cap (Tris formulation, no dilution) August 31, 2022
Fact Sheet Healthcare Providers Bivalent Booster 12 years of age and older, gray border August 31, 2022
Fact Sheet Recipients and Caregivers Primary Series and Bivalent Booster 12 years of age and older, purple and gray border August 31, 2022
Frequently Asked Questions on the Pfizer-BioNTech COVID-19 Vaccine All All All February 16, 2022

Pfizer-BioNTech Regulatory Information

Information Date
Decision Memorandum August 31, 2022
Letter of Authorization (Reissued) August 31, 2022
Letter Granting EUA Amendment June 28, 2022
Decision Memorandum June 17, 2022
Letter Granting EUA Amendment June 1, 2022
Decision Memorandum May 17, 2022
Letter Granting EUA Amendment April 26, 2022
Letter Granting EUA Amendment April 13, 2022
Decision Memorandum March 28, 2022
Letter Granting EUA Amendment January 31, 2022
Decision Memorandum Addendum January 6, 2022
Decision Memorandum December 30, 2021
Decision Memorandum December 8, 2021
Decision Memorandum Addendum November 19, 2021
Decision Memorandum November 19, 2021
Decision Memorandum 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
Letter Granting EUA Amendment September 1, 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 Conference August 31, 2022
Press Release August 31, 2022
Press Conference June 17, 2022
Press Release June 17, 2022
Advisory Committee Webcast June 15, 2022
Press Release May 17, 2022
Media Call March 29, 2022
Press Release March 29, 2022
Press Release January 3, 2022
Press Release November 19, 2021
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 for 6 months through 4 years of age
 

Translations of the Pfizer-BioNTech Fact Sheet for Recipients and Caregivers for 5 through 11 years of age
 

Translations of the Pfizer-BioNTech Fact Sheet for Recipients and Caregivers for 12 years of age and older

 

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