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  1. Coronavirus Disease 2019 (COVID-19)

Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions

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September 22, 2021: FDA authorizes Pfizer-BioNTech COVID-19 Vaccine booster dose for certain populations. View press release.

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, for the administration of a third dose in certain immunocompromised individuals, and for a single booster dose in certain populations. For all information about Comirnaty, please refer to its product page and frequently asked questions.

 

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