PFIZER-BIONTECH COVID-19 VACCINE COMIRNATY® RECEIVES FULL U.S. FDA APPROVAL FOR INDIVIDUALS 16 YEARS AND OLDER
Indication & Authorized Use
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: prevent COVID-19 in individuals 12 through 15 years, and provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to:
prevent COVID-19 in individuals 12 years of age and older, and provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series. An individual may be offered either COMIRNATY® (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.
EUA Statement
This emergency use of the product has not been approved or licensed by FDA, but has been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
Important Safety Information
Individuals should not get the Pfizer-BioNTech COVID-19 Vaccine if they:
had a severe allergic reaction after a previous dose of this vaccine
had a severe allergic reaction to any ingredient of this vaccine
Individuals should tell the vaccination provider about all of their medical conditions, including if they:
have any allergies
have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart) have a fever
have a bleeding disorder or are on a blood thinner
are immunocompromised or are on a medicine that affects the immune system
are pregnant, plan to become pregnant, or are breastfeeding have received another COVID-19 vaccine
have ever fainted in association with an injection
The vaccine may not protect everyone.
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-covid-19-vaccine-comirnatyr-receives-full
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have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart) have a fever"
And THAT is precisely what the FDA is requiring them to study over the next several YEARS. Admitting that there are "serious" concerns about these inflammations.
Additionally, I'd wager that a big majority of people who have had either of these inflammations probably didn't even know about it, or at least, were never diagnosed with it for a variety of reasons.