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  1. Coronavirus Disease 2019 (COVID-19)

Comirnaty and Pfizer-BioNTech COVID-19 Vaccine

June 17, 2022: FDA authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for children down to 6 months of age. View press release and press conference.

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 will now be marketed as Comirnaty, for the prevention of COVID-19 in individuals 16 years of age and older.

Pfizer-BioNTech COVID-19 Vaccine is authorized for emergency use 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.
  • First booster dose for individuals 12 years of age and older at least five months after completing a primary series of the Pfizer-BioNTech COVID-19 Vaccine or Comirnaty vaccine.
  • First booster dose for individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The dosing interval for this first booster dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination.
  • Second booster dose for individuals 50 years of age and older at least four months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.
  • Second booster dose for individuals 12 years of age and older with certain kinds of immunocompromise at least four months after receipt of a first booster dose of any authorized or approved 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) December 2021
Package Insert (gray cap) December 2021
Approval Letter August 23, 2021
Supplement Approval Letter December 16, 2021
Summary Basis for Regulatory Action November 8, 2021
FAQ for Comirnaty (COVID-19 Vaccine mRNA) (Español) February 2, 2022
CDC-issued Emergency Use Instructions (updated) February 11, 2022

 

Pfizer-BioNTech Fact Sheets (English) and FAQs

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

Pfizer-BioNTech Regulatory Information

Information Date
Decision Memorandum June 17, 2022
Letter of Authorization (Reissued) 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 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 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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