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 6 months of age and older:

• Immunocompromised individuals 6 months through 4 years of age who have received three doses (Pfizer-BioNTech COVID-19 Vaccine or Pfizer BioNTech COVID-19 Vaccine, Bivalent): A fourth dose with Pfizer BioNTech COVID-19 Vaccine, Bivalent may be administered at least 1 month following the most recent dose; additional doses of Pfizer-BioNTech COVID-19 Vaccine, Bivalent may be administered at the discretion of the healthcare provider.
• 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

Pfizer-BioNTech Regulatory Information (Emergency Use Authorization)

Federal Register Notices

Translations of the Fact Sheet for Recipients and Caregivers