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.

 

Pfizer-BioNTech Fact Sheets (English) and FAQs

Material Audience Vaccine Purpose Vaccine Recipient Group Last Updated
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

Media Materials and Webcasts

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