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FDA Approves First COVID-19 Vaccine
fda.gov ^ | 8/23/2021 | Unknown

Posted on 08/23/2021 1:03:46 PM PDT by rktman

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.

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


TOPICS: Constitution/Conservatism; Culture/Society; Government; Philosophy
KEYWORDS: approved; lineup; lyingliars
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So, the FDA has indeed approved a drug. One problem I see is that despite their claim, "Comirnaty" does NOT prevent CONvid-19 from being contracted. Lying liars and the lies they lie about. We have at least 4 friends that were "fully vaxxed" (not sure which vax) that have gotten infected within the last month.
1 posted on 08/23/2021 1:03:46 PM PDT by rktman
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To: rktman

COMIRNATY name explanation. HT JimNoble - TY definition added by me

CO = COronavirus

M[I]RNA = mRNA + a necessary vowel

TY = Thank You

for making us billionaires


2 posted on 08/23/2021 1:05:03 PM PDT by Pollard
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To: rktman

Others here were stating that it was merely an extension of the EUA. Anyone know for certain?


3 posted on 08/23/2021 1:05:27 PM PDT by EEGator
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To: rktman
From 2019...

Former FDA Commissioner Scott Gottlieb Joins Pfizer's Board of Directors

Interesting timing, eh?

4 posted on 08/23/2021 1:07:28 PM PDT by mewzilla (Those aren't masks. They're muzzles. )
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To: EEGator

The FDA letter is under the thread on Biden’s presser. From what I can figure, they have a lot of the EUA vaccines leftover so the letter extends the EUA for their use while also licensing Pfizer to market its brand name vaccine.


5 posted on 08/23/2021 1:08:36 PM PDT by Blogger (Prayers for our REAL President, First Lady and Republic.)
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To: EEGator

Read the link from the FDA that I used for this post. The previous link sort of sounded like an extension of the EUA but this memo sure sounds like it’s a go.


6 posted on 08/23/2021 1:08:45 PM PDT by rktman (Destroy America from within? Check! WTH? Enlisted USN 1967 to end up with this? 😕)
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To: rktman

I am still not going to get the shot/s.


7 posted on 08/23/2021 1:08:46 PM PDT by ro_dreaming ("XX = female; XY = male. Who's the science deniers now?" - Me)
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To: rktman

With 205,000,000 doses of the Pfizer vaccine administered in the United States, was there any doubt that it would be approved?

The fix was in.


8 posted on 08/23/2021 1:09:15 PM PDT by thegagline
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To: EEGator

The link to the full FDA approval is at the top of the thread.


9 posted on 08/23/2021 1:09:56 PM PDT by phoneman08 (qwiyrqweopigradfdz oncm,.dadfjl,dz )
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To: EEGator

Approved for 16 and older

EAU reauth for 12-15 and any other cases that approval doesn’t cover


10 posted on 08/23/2021 1:10:12 PM PDT by Pollard
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To: EEGator

I just reread that August 23rd letter.

I’m still bleeping confused about the status of what’s approved/authorized for whom.

Was there any paperwork put out by the FDA today, anyone know?


11 posted on 08/23/2021 1:11:18 PM PDT by mewzilla (Those aren't masks. They're muzzles. )
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To: rktman

3 acquaintances that took the jab back in mid-June/early July are now dead.
The last one died last week Two of em were in petty poor health to begin with and died in early August. The last one was a 54 year-old male in decent health for his age. It took awhile to take him out, but it finally got him. As far as I know, none of em had previously had the disease.
FWIW, there are folks that literally need to be publicly hanged for this BS.


12 posted on 08/23/2021 1:11:41 PM PDT by lgjhn23 (Pray for America....)
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To: Blogger; rktman; phoneman08

Thank you all.


13 posted on 08/23/2021 1:11:43 PM PDT by EEGator
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To: Pollard

https://www.fda.gov/media/150386/download

EUA reauth - page 2 explains it


14 posted on 08/23/2021 1:11:45 PM PDT by Pollard
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To: ro_dreaming

We neither. One concern is I have a carotid surgery scheduled on 9/8 and I need to be tested prior to. Regardless, no shot. Since it doesn’ prevent getting the CONvid-19 anyway....... :-)


15 posted on 08/23/2021 1:11:51 PM PDT by rktman (Destroy America from within? Check! WTH? Enlisted USN 1967 to end up with this? 😕)
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To: ro_dreaming

I’m not. (no sarcasm tag)
How did it get full approval in 8 months? Care to explain that?


16 posted on 08/23/2021 1:12:56 PM PDT by EEGator
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To: ro_dreaming

Same here. They can approve it, give it a gold star rating and give Pfizer scientists nobel prizes. Still not interested.


17 posted on 08/23/2021 1:13:03 PM PDT by Pollard
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To: mewzilla

Link for this thread.


18 posted on 08/23/2021 1:13:06 PM PDT by rktman (Destroy America from within? Check! WTH? Enlisted USN 1967 to end up with this? 😕)
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To: rktman

Thanks! Has anything been issued since, anyone know?


19 posted on 08/23/2021 1:13:46 PM PDT by mewzilla (Those aren't masks. They're muzzles. )
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To: rktman

.


20 posted on 08/23/2021 1:14:00 PM PDT by exnavy (grow some thick skin, i do not care for whiners)
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