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Correct me if I’m wrong but the FDA did NOT authorize the Pfizer vaccine.

Posted on 8/24/21 at 4:43 am
Posted by GumboPot
Member since Mar 2009
118760 posts
Posted on 8/24/21 at 4:43 am
They just re-upped the EUA:

quote:

On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA.


LINK

I posted this on the poli board but thought I would post it here too for more eyes. This needs clarification because many company and school policies are being triggered by the media’s declaration that the Pfizer vaccine is out from under the FDA EUA and fully authorized. It appears it’s not.
Posted by kciDAtaE
Member since Apr 2017
15759 posts
Posted on 8/24/21 at 4:48 am to
Why is the FDA commissioner referring to it as the first FDA approved vaccine?
Posted by GumboPot
Member since Mar 2009
118760 posts
Posted on 8/24/21 at 4:49 am to
IDK
Posted by Strannix
District 11
Member since Dec 2012
48908 posts
Posted on 8/24/21 at 4:50 am to
I wonder I we will ever get to see the real numbers
This post was edited on 8/24/21 at 5:01 am
Posted by GumboPot
Member since Mar 2009
118760 posts
Posted on 8/24/21 at 4:52 am to
quote:

Even the FDA in full propaganda mode isn't stupid enough to approve this vaccine, the actual bad numbers are unbelieveable



But the media and politicians are saying the Pfizer vaccine is fully approved and out from under the EUA. It appears it’s not.
Posted by TDsngumbo
Alpha Silverfox
Member since Oct 2011
41578 posts
Posted on 8/24/21 at 4:53 am to
quote:

This needs clarification because many company and school policies are being triggered by the media’s declaration that the Pfizer vaccine is out from under the FDA EUA and fully authorized. It appears it’s not.

The very link you posted gives you all the clarification you’re looking for. Go back and read it in its entirety. I suspect you didn’t. The Pfizer vaccine has indeed been fully authorized and this authorization simply reissues the EUA that they previously issued but fully authorized it from today forward. I can see how it’s a little confusing but read the whole thing.

quote:

On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.

quote:

On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA.



Y’all stupid anti-vaccine motherfrickers need to learn how to read and comprehend what you read. No fricking wonder y’all are the way y’all are.
This post was edited on 8/24/21 at 4:57 am
Posted by Jon Ham
Member since Jun 2011
28587 posts
Posted on 8/24/21 at 4:53 am to
Posted by Gorilla Ball
Member since Feb 2006
11665 posts
Posted on 8/24/21 at 4:54 am to
I could care less
Posted by GumboPot
Member since Mar 2009
118760 posts
Posted on 8/24/21 at 5:00 am to
From the section you quoted:

quote:

the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses
Posted by GumboPot
Member since Mar 2009
118760 posts
Posted on 8/24/21 at 5:06 am to
Your screenshot instructs us the Pfizer vaccine is under EUA.
Posted by FCP
Delta State Univ. - Fightin' Okra
Member since Sep 2010
4785 posts
Posted on 8/24/21 at 5:08 am to
quote:

Correct me if I’m wrong
You're wrong.
Posted by LSUCanFAN
In the past
Member since Jan 2009
28071 posts
Posted on 8/24/21 at 5:09 am to
quote:


Y’all stupid anti-vaccine motherfrickers need to learn how to read and comprehend what you read. No fricking wonder y’all are the way y’all are.
tell me y’all are from the South without saying y’all are from the south.
Posted by TDsngumbo
Alpha Silverfox
Member since Oct 2011
41578 posts
Posted on 8/24/21 at 5:09 am to
quote:

From the section you quoted:

quote:
the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses



Oh, come on?!
Posted by GumboPot
Member since Mar 2009
118760 posts
Posted on 8/24/21 at 5:13 am to
quote:

Oh, come on?!


If the FDA says the Pfizer vaccine will remain under EUA, what do you want me to interpret that as?
Posted by TDsngumbo
Alpha Silverfox
Member since Oct 2011
41578 posts
Posted on 8/24/21 at 5:13 am to
quote:

Your screenshot instructs us the Pfizer vaccine is under EUA.

This thread, for me at least, puts to bed all the anti-vaccine arguments here. I had no idea that all this time you people don’t even have basic reading comprehension skills. No way in hell am I ever taking anything any anti-vaxer here says seriously anymore. Holy shite.
This post was edited on 8/24/21 at 5:19 am
Posted by TDsngumbo
Alpha Silverfox
Member since Oct 2011
41578 posts
Posted on 8/24/21 at 5:14 am to
quote:

If the FDA says the Pfizer vaccine will remain under EUA, what do you want me to interpret that as?

It would be nice if you could continue reading.
Posted by The Spleen
Member since Dec 2010
38865 posts
Posted on 8/24/21 at 5:15 am to
The answer is in the paragraph preceding the one you quoted, Einstein.
Posted by scottfruget
Member since Nov 2010
3392 posts
Posted on 8/24/21 at 5:15 am to
What it should do is cause you to question the governments ability to write a clear document—although we already knew that was the case (you must pass the bill to know what it’s in it).
Posted by TDsngumbo
Alpha Silverfox
Member since Oct 2011
41578 posts
Posted on 8/24/21 at 5:18 am to
quote:

What it should do is cause you to question the governments ability to write a clear document—although we already knew that was the case (you must pass the bill to know what it’s in it).



I had no problem understanding it.
Posted by GumboPot
Member since Mar 2009
118760 posts
Posted on 8/24/21 at 5:18 am to
You should stop getting emotional about this. I’m simply trying to get to the bottom of this. Nothing you’ve posted says the FDA fully authorized the Pfizer vaccine. In fact to the contrary.
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