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  1. Coronavirus Disease 2019 (COVID-19)

Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions

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August 23, 2021: FDA approves Comirnaty (COVID-19 Vaccine, mRNA), which was previously known as Pfizer-BioNTech COVID-19 Vaccine, for the prevention of COVID-19 disease in individuals 16 years of age and older. View Comirnaty informationpress release and frequently asked questions.

On December 11, 2020, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. On May 10, 2021, the FDA expanded the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.

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 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. Comirnaty has the same formulation as Pfizer-BioNTech COVID-19 Vaccine that continues to be available under emergency use authorization, including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals. For all information about Comirnaty, please refer to its product page and frequently asked questions.

 

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