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  1. Coronavirus (COVID-19) | CBER-Regulated Biologics

Pfizer-BioNTech COVID-19 Vaccine

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) Authorized For Individuals 6 Months through 11 Years of Age

 

 

On September 11, 2023, the Food and Drug Administration amended the emergency use authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine to include the 2023-2024 formula. The Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) includes a monovalent (single) component that corresponds to the Omicron variant XBB.1.5 of SARS-CoV-2. The Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) is authorized for all doses administered to individuals 6 months through 11 years of age to prevent COVID-19. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is no longer authorized for use in the United States.

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) is authorized for use as follows:

Individuals 6 months through 4 years of age:

  • Unvaccinated individuals: Three doses of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) are administered. The first two doses are administered three weeks apart. The third dose is administered at least 8 weeks after the second dose.
  • Individuals who have received one dose of any Pfizer BioNTech COVID-19 Vaccine, including Pfizer-BioNTech COVID-19 Vaccine, Bivalent: Two doses of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) are administered. The first dose of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) is administered three weeks after receipt of the previous dose and the second dose is administered at least 8 weeks later.
  • Individuals who have received two to four doses of any Pfizer BioNTech COVID-19 Vaccine, including Pfizer-BioNTech COVID-19 Vaccine, Bivalent: A single dose of Pfizer-BioNTech COVID 19 Vaccine (2023-2024 Formula) is administered at least 8 weeks after receipt of the last previous dose.

Individuals 5 years through 11 years of age, regardless of vaccination status:

  • A single dose of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula). If previously vaccinated with any COVID-19 vaccine, administer at least 2 months after receipt of the last previous dose of any COVID-19 vaccine.

Immunocompromised individuals 6 months through 11 years of age::

  • Complete at least a three-dose series with a COVID-19 vaccine, each dose one month apart. At least one dose should be with a COVID-19 vaccine (2023-2024 Formula).

Pfizer-BioNTech COVID-19 Fact Sheets and Materials

Material Audience Last Updated
Fact Sheet Recipient and Caregiver September 11, 2023
Fact Sheet Healthcare Provider December 8, 2023
Dear Healthcare Provider Letter Healthcare Professionals September 11, 2023

Pfizer-BioNTech Regulatory Information (Emergency Use Authorization)

Information Date
Granting Letter December 8, 2023
Concurrence Letter November 15, 2023
Decision Memorandum September 11, 2023
Letter of Authorization (Reissued) September 11, 2023

Federal Register Notices

Translations of the Fact Sheet for Recipients and Caregivers

 

 
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