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

Pfizer-BioNTech COVID-19 Vaccine

Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) Authorized For Individuals 6 Months through 11 Years of Age

 

 

Pfizer-BioNTech Fact Sheets Fact Sheet Translations Vacunas contra el COVID-19

On August 22, 2024, the Food and Drug Administration amended the emergency use authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine to include the 2024-2025 formula. The Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) includes a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2. The Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) is authorized for all doses administered to individuals 6 months through 11 years of age to prevent COVID-19.

Pfizer-BioNTech COVID-19 Vaccine (2024-2025 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 (2024-2025 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 previous dose of any Pfizer BioNTech COVID-19 Vaccine that is no longer authorized for use in the United States: Two doses of Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) are administered. The first dose of Pfizer-BioNTech COVID-19 Vaccine (2024-2025 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 or more previous doses of any Pfizer BioNTech COVID-19 Vaccine that is no longer authorized for use in the United States: A single dose of Pfizer-BioNTech COVID 19 Vaccine (2024-2025 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 (2024-2025 Formula). If previously vaccinated with any COVID-19 vaccine that is no longer authorized for use in the United States, 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 with an age appropriate dose and dosing schedule. At least one dose should be with a COVID-19 vaccine (2024-2025 Formula).

Pfizer-BioNTech COVID-19 Fact Sheets and Materials

Material Audience Last Updated
Fact Sheet Recipient and Caregiver August 22, 2024
Fact Sheet Healthcare Provider August 22, 2024

Pfizer-BioNTech Regulatory Information (Emergency Use Authorization)

Information Date
Granting Letter December 8, 2023
Concurrence Letter November 15, 2023
Decision Memorandum August 22, 2024
Letter of Authorization (Reissued) August 22, 2024

Federal Register Notices

Title Date
Authorizations of Emergency Use of Two Biological Products During the COVID-19 Pandemic; Availability January 19, 2021

 

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