Pfizer-BioNTech COVID-19 Vaccine

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

Pfizer-BioNTech Regulatory Information (Emergency Use Authorization)