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  2. Dec 11, 2020 · COMIRNATY ® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older; It is also authorized under Emergency Use Authorization (EUA) to be administered for emergency use to:

  3. Sep 11, 2023 · On September 11, 2023, the Food and Drug Administration amended the emergency use authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine to include the 2023-2024 formula. The...

  4. COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. It is approved as a 2-dose series for prevention of COVID-19 in individuals 12 years of age and older. It is also authorized under EUA to provide:

  5. Aug 30, 2021 · On August 23, Pfizer-BioNTech's Covid-19 vaccine was granted official approval for use in individuals 16 years of age and older by the United States Food and Drug Administration (FDA)....

  6. Aug 23, 2021 · Post. For Immediate Release: August 23, 2021. Español. Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech...

  7. Sep 11, 2023 · IMPORTANT SAFETY INFORMATION. You should NOT receive COMIRNATY ® (COVID-19 Vaccine, mRNA) if you have had a severe allergic reaction to any ingredient of COMIRNATY or a previous dose of a Pfizer-BioNTech COVID-19 vaccine. There is a remote chance that COMIRNATY could cause a severe allergic reaction.

  8. In September 2023, the FDA approved an updated monovalent (single) component Omicron variant XBB.1.5 version of the vaccine (Comirnaty 2023–2024 formula) as a single dose for individuals aged twelve years of age and older; and authorized the Pfizer-BioNTech COVID-19 Vaccine 2023–2024 formula under emergency use for individuals aged 6 months ...

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