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.

---

Comirnaty Information

 

Pfizer-BioNTech Fact Sheets (English) and FAQs

Pfizer-BioNTech Regulatory Information

Media Materials and Webcasts

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