Today, the U.S. Food and Drug Administration 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 (koe-mir’-na-tee), 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 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

STN: 125742
Proper Name: COVID-19 Vaccine, mRNA
Tradename: Comirnaty
Manufacturer: BioNtech Manufacturing GmbH
Indication:  Comirnaty is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID 19) caused by severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) in individuals 16 years of age and older.

For full media release go to:  FDA Approves First COVID-19 Vaccine | FDA

For approval letter and package insert go to:  https://www.fda.gov/vaccines-blood-biologics/comirnaty