WelcomeUser Guide
ToSPrivacyCanary
DonateBugsLicense

©2026 Poal.co

159

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.

(post is archived)

[–] 0 pt

thanks. this is the best read explaining it.