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In its approval letter to BioNTech, the FDA mandated Pfizer to submit several study results evaluating the occurrence of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the heart’s surrounding membrane) following administration of the vaccine.

The final results of a study “entitled “A Non-Interventional Post-Approval Safety Study of the Pfizer-BioNTech COVID-19 mRNA Vaccine in the United States,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY is due October 31, 2025.

The final results of another study evaluating the occurrence of myocarditis and pericarditis following administration of the vaccine is due on September 30, 2024.

> In its approval letter to BioNTech, the FDA mandated Pfizer to submit several study results evaluating the occurrence of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the heart’s surrounding membrane) following administration of the vaccine. > The final results of a study “entitled “A Non-Interventional Post-Approval Safety Study of the Pfizer-BioNTech COVID-19 mRNA Vaccine in the United States,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY is due October 31, 2025. > The final results of another study evaluating the occurrence of myocarditis and pericarditis following administration of the vaccine is due on September 30, 2024.

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[–] [deleted] [Sticky] • 1 pt

It is not actually approved, the EUA was simply extended and they said that is fully approved.

https://www.fda.gov/media/150386/download

On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA.

[–] • 1 pt

I want to sticky this comment but can't!!!

, can you help?

[–] • 1 pt

Didn't see this till now but done