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To: Farcesensitive
said, "the FDA has “fully approved”"

That isn't how I read this thing. They renewed the emergency authorization

Under: II. Scope of Authorization
I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is limited as follows:
• Pfizer Inc. will supply Pfizer-BioNTech COVID‑19 Vaccine either directly or through authorized distributor(s), 11 to emergency response stakeholders12 as directed by the U.S
https://www.fda.gov/media/150386/download

Section 564 is the Emergency use authorization
https://astho.org/Programs/Preparedness/Public-Health-Emergency-Law/Emergency-Use-Authorization-Toolkit/Section-564-of-the-Federal-Food,-Drug,-and-Cosmetic-Act-Fact-Sheet/
309 posted on 08/23/2021 8:32:56 PM PDT by Steve Van Doorn (*in my best Eric Cartman voice* 'I love you, guys')
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To: Steve Van Doorn

I have not read the actual documents yet.
But this is what I have been told:


“From the FDA press release:

Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

So there is both an approval for 16+ and an EUA for boosters and 12-15 year olds.”


314 posted on 08/23/2021 8:44:31 PM PDT by Farcesensitive (K is coming)
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To: Steve Van Doorn

Exactly how I read it as well.


370 posted on 08/23/2021 10:33:37 PM PDT by reed13k (For evil to triumph it is only necessary that good men do nothing)
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