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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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[–] [deleted] • 0 pt (edited )

It's confusing, but what I'm sussing out is that, COMIRNATY is fully approved, but there isn't a lot of the drug produced by BioNTech under the name COMIRNATY to fully vaccinate the population.

Since they don't have enough of COMIRNATY, they still need to re-authorize Pfizer's mRNA Covid Vaccine under the EUA. In addition, COMIRNATY isn't authorized for ages 12-15, only the Pfizer mRNA Covid Vaccine is, so the only way to vaccinate everyone down to age 12 is to keep the EUA-only version. That's what I'm getting out of it.

I'm not really sure why it's being said in the way that it is...but my suspicion is they know they're rushing approval, and that even with approval they can't get everyone vaccinated that they want, which is everybody. They're treating the two drugs as if they are different drugs, based on who filed for what, while being able to talk about them as if they're identical. Perhaps this is Pfizer's way of avoiding responsibility. You can now sue BioNTech if COMIRNATY harms you. You still can't sue Pfizer for the EUA vaccine, because of the EUA.

So the point of rushed approval is to get the hesitant to take their shots. They think 30% of us were just waiting for approval. Maybe so, but rushed approval is just as bad as no approval to me. Maybe they're also hoping that the confusion in the names will get people to trust the EUA vaccine in addition to COMIRNATY. And, of course, now they can market COMIRNATY, with TV ads and such. Being that COMIRNATY is the same as Pfizers EUA vaccine, they're technically getting to market their still experimental vaccine.

[–] • 1 pt

thanks for making my head spinnnnnnnnnnnnnnnnnnnnnnnnnnn