On August 23, 2021, the FDA approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older.

The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 5 years of age and older, for the administration of a third dose in certain immunocompromised people, and for a single booster dose in people:

• 65 and older
• 18 through 64 at high risk of severe COVID-19
• 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.

On October 20, 2021, the FDA authorized the use of a heterologous (or “mix and match”) booster dose in eligible populations with currently available (i.e., FDA-authorized or approved) COVID-19 vaccines. Therefore, Pfizer-BioNTech COVID-19 vaccine recipients falling into one of the authorized categories for boosters may receive  the Moderna COVID-19 Vaccine (half dose), Pfizer-BioNTech COVID-19 Vaccine or Janssen COVID-19 Vaccine and should be given at least six months after completing the primary vaccination.

On November 17, 2021, CDC, in consultation with FDA, issued emergency use instructions about the use of the vaccine for the additional primary doses or booster doses in certain individuals who completed vaccination with a certain non-FDA-authorized or -approved vaccine.

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Comirnaty Information

 

Pfizer-BioNTech Fact Sheets (English) and FAQs

Pfizer-BioNTech Regulatory Information

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Translations of the Pfizer-BioNTech Fact Sheet for Recipients and Caregivers