Pfizer-BioNTech COVID-19 Vaccines
Pfizer-BioNTech COVID-19 Vaccine, Bivalent Now Authorized For All Doses
April 18, 2023: FDA authorizes changes to simplify use of bivalent mRNA COVID-19 vaccines. Read the press release and listen to the media call.
On April 18, 2023, the Food and Drug Administration amended the emergency use authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine, Bivalent to simplify the vaccination schedule for most individuals. This action includes authorizing the current bivalent vaccine (Original and Omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older. The monovalent Pfizer-BioNTech COVID-19 Vaccine is no longer authorized for use in the United States.
Pfizer-BioNTech COVID-19 Vaccine, Bivalent is now authorized for use as follows:
Individuals 6 months through 4 years of age:
- Unvaccinated individuals: Three doses of Pfizer-BioNTech COVID-19 Vaccine, Bivalent are administered over at least 11 weeks. 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 the monovalent Pfizer BioNTech COVID-19 Vaccine: Two doses of Pfizer-BioNTech COVID-19 Vaccine, Bivalent are administered. The first dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent is given three weeks after the monovalent Pfizer-BioNTech COVID-19 Vaccine and the second dose at least 8 weeks later.
- Individuals who have received two doses of the monovalent Pfizer BioNTech COVID-19 Vaccine: A single dose of Pfizer-BioNTech COVID 19 Vaccine, Bivalent is administered at least 8 weeks after the monovalent Pfizer-BioNTech COVID-19 Vaccine.
- Individuals who have received three doses of the monovalent Pfizer BioNTech COVID-19 Vaccine: A single dose of Pfizer-BioNTech COVID 19 Vaccine, Bivalent is administered at least 2 months after the monovalent Pfizer BioNTech COVID-19 Vaccine.
Individuals 5 years of age and older:
- Unvaccinated individuals: A single dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent.
- Individuals who have received one or more doses of a monovalent COVID 19 vaccine: A single dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent is administered at least 2 months after any monovalent COVID-19 vaccine.
- Individuals 65 years of age and older who have received one dose of a bivalent COVID-19 vaccine: A dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent may be administered at least 4 months after the dose of the bivalent COVID-19 vaccine.
- Immunocompromised individuals 5 years of age and older who have received one dose of a bivalent COVID-19 vaccine: An additional dose with Pfizer-BioNTech COVID-19 Vaccine, Bivalent may be administered at least 2 months following the dose of the bivalent COVID-19 vaccine; additional doses may be administered at the discretion of the healthcare provider.
Pfizer-BioNTech Fact Sheets
Material | Audience | Last Updated |
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Fact Sheet | Recipient and Caregiver | April 18, 2023 |
Fact Sheet | Healthcare Professional | April 18, 2023 |
Pfizer-BioNTech Regulatory Information (Emergency Use Authorization)
Information | Date |
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Decision Memorandum | April 18, 2023 |
Letter of Authorization (Reissued) | April 18, 2023 |
Federal Register Notices
Title | Date |
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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