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Application for licensure of a booster dose for COMIRNATY (COVID-19 Vaccine, mRNA)
FDA ^ | Pfizer

Posted on 09/15/2021 11:06:50 AM PDT by Meah

Vaccines and Related Biological Products Advisory Committee Meeting September 17, 2021 FDA Briefing Document Application for licensure of a booster dose for COMIRNATY (COVID-19 Vaccine, mRNA) https://www.fda.gov/media/152176/download

(Excerpt) Read more at fda.gov ...


TOPICS:
KEYWORDS: boostershot; chinavirusvaccine; comirnaty; fda
Pfizer Briefing Book for FDA approval of the booster shot. 1. Tested only young and immune-competent people even though the booster is for old and immune-compromised people. 2. Sample size 300. 3. Didn’t test for efficacy.
1 posted on 09/15/2021 11:06:50 AM PDT by Meah
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To: Jane Long

Ping.


2 posted on 09/15/2021 11:12:03 AM PDT by Army Air Corps (Four Fried Chickens and a Coke)
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To: Meah

- Comernaty is the only mRNA vaccine that has full FDA approval
- Comernaty is a product that is yet to be manufactured
- Current Pfizer BioNTech mRNA vaccine remains under EUA, which has been extended. The EUA was approved for teenagers.
- There are millions of doses of Pfizer BioNTech mRNA vaccines that will be dispensed as “Comirnaty” in an attempt to fool the patients.
- The two products are not the same.


3 posted on 09/15/2021 11:18:41 AM PDT by Chauncey Gardiner
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To: Meah

If Pfizer and the FDA are now defining efficacy as an immune response (antibodies?), then it seems like this will undercut the OSHA mandate for employers to test unvaccinated employees, who might also have a sufficient “immune response” to natural SARS-CoV2 infection by means of their God-given immune system.


4 posted on 09/15/2021 11:19:46 AM PDT by Meah (The terrain is everything. ~Louis Pasteur )
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To: Chauncey Gardiner
Its Comirnaty. It absolutely has been manufactured.

Here are some vials with lot numbers.


5 posted on 09/15/2021 11:28:02 AM PDT by TexasGurl24
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To: Chauncey Gardiner

Chauncey Gardiner wrote: “- Comernaty is the only mRNA vaccine that has full FDA approval”

You must have forgot to mention that Comernaty is identical to the Pfizer BioNTech mRNA


6 posted on 09/15/2021 11:43:42 AM PDT by DugwayDuke (Most pick the expert who says the things they agree with.)
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To: DugwayDuke

But the EUA is still in effect for all Pfizer not labeled Comirnaty, hence still experimental. It is a bait and switch to say that this injection can be forced upon an unwilling subject


7 posted on 09/15/2021 12:01:03 PM PDT by Mygirlsmom (Back after a long hiatus. Now mygrandkidsgrandma)
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To: Chauncey Gardiner

Chauncey Gardiner wrote:

“- Comernaty is the only mRNA vaccine that has full FDA approval
- Comernaty is a product that is yet to be manufactured
- Current Pfizer BioNTech mRNA vaccine remains under EUA, which has been extended. The EUA was approved for teenagers.
- There are millions of doses of Pfizer BioNTech mRNA vaccines that will be dispensed as “Comirnaty” in an attempt to fool the patients.
- The two products are not the same.”

How do we know that the two products are not the same, if the comirnaty is not yet available?


8 posted on 09/15/2021 12:49:24 PM PDT by WildHighlander57 ((WildHighlander57 returning after lurking since 2000) )
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To: Meah

COMIRNATY is NOT AVAILABLE. You cannot ask to be injected with it, because it is NOT out of trial. In fact, there are NO FDA-approved COVID “vaccines” (actually, they’re all gene therapies; they contain no live or killed virus).


9 posted on 09/15/2021 12:58:14 PM PDT by backwoods-engineer (But what do I know? I'm just a backwoods engineer.)
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To: Mygirlsmom

Mygirlsmom wrote: “But the EUA is still in effect for all Pfizer not labeled Comirnaty, hence still experimental. It is a bait and switch to say that this injection can be forced upon an unwilling subject”

They are identical. Why do you think that a EUA is experimental? You’re just playing with words.


10 posted on 09/15/2021 1:56:44 PM PDT by DugwayDuke (Most pick the expert who says the things they agree with.)
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To: Meah

Pfizer admits with their filing for a booster that they know it’s not a vaccine and that it doesn’t work.


11 posted on 09/15/2021 2:08:50 PM PDT by T.B. Yoits
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To: DugwayDuke

It’s going to be hard to explain to you unless you understand the terms. Even if they were chemically identical, the EUA was not revoked for the non-Comirnaty vials, so they are legally not the same


12 posted on 09/15/2021 2:39:41 PM PDT by Mygirlsmom (Back after a long hiatus. Now mygrandkidsgrandma)
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To: Meah

ISn’t this the “vaccine” that was approved but won’t be available until 2027?

These people are MAD!


13 posted on 09/15/2021 6:10:22 PM PDT by RebelTXRose (Our Lady of Fatima, Pray for us! PRAY THE ROSARY!)
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