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Comirnaty and Pfizer-BioNTech
COVID-19 Vaccine - FDA Grants Full Approval
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pdf package insert attached and at link
Download the PDF here
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 information, press release and frequently asked questions.
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 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
https://www.fda.gov/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine?fbclid=IwAR0UcF9PtS1C_G1zzp1Qw4BKfMSnzncQu4Jw4A1YRveFk8CxPiutpQAOjeA
PACKAGE INSERT
Download the PDF here
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