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sorry the typo: interpretation

Two documents: https://www.fda.gov/media/151710/download https://www.fda.gov/media/150386/download

The FDA Letter: Our STN: BL 125742/0 - BLA APPROVAL BioNTech Manufacturing GmbH August 23, 2021 Attention: Amit Patel
Pfizer Inc.
235 East 42nd Street
New York, NY 10017 Dear Mr. Patel:

It appears that the "BLA APPROVAL" only gives Pfizer an authorization (license) to manufacture the COVID-19 Vaccine and use it in accordance to the guidelines of the EUA.

And this FDA Letter: August 23, 2021
Pfizer Inc. Attention: Ms. Elisa Harkins 500 Arcola Road Collegeville, PA 19426
Dear Ms. Harkins:

Only gives Pfizer the reauthorization of the EUA.

Am I on the right track? Is there another document that clearly spells out everything.

sorry the typo: interpretation Two documents: https://www.fda.gov/media/151710/download https://www.fda.gov/media/150386/download The FDA Letter: Our STN: BL 125742/0 - BLA APPROVAL BioNTech Manufacturing GmbH August 23, 2021 Attention: Amit Patel Pfizer Inc. 235 East 42nd Street New York, NY 10017 Dear Mr. Patel: It appears that the "BLA APPROVAL" only gives Pfizer an authorization (license) to manufacture the COVID-19 Vaccine and use it in accordance to the guidelines of the EUA. And this FDA Letter: August 23, 2021 Pfizer Inc. Attention: Ms. Elisa Harkins 500 Arcola Road Collegeville, PA 19426 Dear Ms. Harkins: Only gives Pfizer the reauthorization of the EUA. Am I on the right track? Is there another document that clearly spells out everything.

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[–] • 0 pt

It’s approved, but just under a different name than the original. For “logistical purposes” the vaccine previously manufactured under a different name will still be EUA. Same vaccine, same formula, just different name and manufacturing date. I think they reaffirmed the EUA for the existing vaccine because there are still a lot of doses sitting around that need to be used up. You can read this Q&A from the FDA regarding the vaccine to confirm:

https://www.fda.gov/vaccines-blood-biologics/qa-comirnaty-covid-19-vaccine-mrna

[–] • 0 pt

thanks. this is the best read explaining it.