Pfizer approval

Yes the FDA did approve the shot for covid. with the brand name COMIRNATY. there is a bit of confusion because they also issued an eua at the same time to expand the use of this drug.

here is the original approval August 23, 2021 Approval Letter – Comirnaty (fda.gov)

this was for adults 16 and up for 2 shots. then they issued another eua to approve other uses that the company did not show proof for yet. that eua is Pfizer-BioNTech COVID-19 Vaccine EUA LOA reissued August 23 2021 (fda.gov)

in that eua they said they are approving uses beyond the original approval conditionally, while they wait for studies that Pfizer needs to do. here is the sentence that everyone is missing-

and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for
certain uses that are not included in the approved BLA.

everyone is getting confused due the language they used. hard reading to be sure, even I missed it the first couple times I read it.

so yes they have approved the drug Comirnaty for covid in ages 16 and up for 2 shots.

(a note that Comirnaty is not the original Pfizer shot but is substantially the same and interchangeable according to the eua.)

(I am still not getting it, i don’t care about the approval. the FDA has been wrong before.)hey said they are approving uses beyond the original approval conditionally, while they wait for studies that Pfizer needs to do. here is the sentence that everyone is missing-

and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for
certain uses that are not included in the approved BLA.

everyone is getting

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