Pfizer-BioNTech COVID-19 Vaccine
Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) Authorized For Individuals 6 Months through 11 Years of Age
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 |
Translations of the Fact Sheet for Recipients and Caregivers