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

Pfizer-BioNTech Regulatory Information (Emergency Use Authorization)

Federal Register Notices

Translations of the Fact Sheet for Recipients and Caregivers

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Pfizer-BioNTech COVID-19 Vaccine

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