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Did the FDA Pull a Bait-and-Switch on the American People?
American Thinker ^ | 27 Aug, 2021 | Steve McCann

Posted on 08/27/2021 3:31:13 AM PDT by MtnClimber

The FDA has licensed Pfizer’s Comirnaty Covid vaccine, NOT the existing Pfizer-BioNTech vaccine – the one that is still being administered, with a large stockpile on hand.

On August 23rd all the mainstream or agitprop media outlets were trumpeting the news that the FDA had granted permanent approval for the Pfizer Covid-19 vaccine. The press breathlessly reported that vaccine mandates were now legal for healthcare workers, employees in private industry, college students and government employees at all levels including teachers and school staff.

Almost immediately Joe Biden shuffled his way to the podium and read off his teleprompter that all businesses should immediately institute vaccine mandates. The Pentagon announced that vaccinations would be mandatory for all active service members. Bill de Blasio immediately instituted a vaccine mandate for all New York city teachers and staff.

SNIP

What the FDA approved and licensed is Pfizer’s Comirnaty Covid vaccine not the current Pfizer-BioNTech Covid vaccine in use under an Emergency Use Authorization (EUA). The FDA has acknowledged that Pfizer has insufficient stocks of the newly licensed Comirnaty vaccine available but there is significant amount of the Pfizer-BioNTech Covid vaccine available under the EUA still on hand.

(Excerpt) Read more at americanthinker.com ...


TOPICS: Health/Medicine; Society
KEYWORDS: covid
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1 posted on 08/27/2021 3:31:13 AM PDT by MtnClimber
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To: MtnClimber

Would you expect openness and clarity to suddenly appear amid the deception?


2 posted on 08/27/2021 3:31:25 AM PDT by MtnClimber (For photos of Colorado scenery and wildlife, click on my screen name for my FR home page.)
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To: MtnClimber

3 posted on 08/27/2021 3:33:35 AM PDT by Travis McGee (EnemiesForeignAndDomestic.com)
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To: MtnClimber
In the 1970s, the Swine Flu vaccine program was halted, full stop, after less than 200 deaths.


4 posted on 08/27/2021 3:34:59 AM PDT by Travis McGee (EnemiesForeignAndDomestic.com)
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To: MtnClimber

“Pfizer Seeking Full Indemnification”
[Dr. Robert Malone on War Room with Steve Bannon. 4 minute video]

Malone says that the new “Comernity” jab that is “FDA approved” is NOT the same as the currently available Pfizer vaxx jab.

“Comernity” is not yet available.

Pfizer and the FDA are playing a “3 card monty” fake switcheroo. They will not make the currently available Pfizer vaxx jab available without the existing extended EUA and full continuing immunity.

The as-yet unavailable “FDA Approved Comernity” at this point is just a fake out to trick the gullible into taking the same old EUA Pfizer vaxx jab.]

https://rumble.com/vlmd4g-pfizer-seeking-full-indemnification.html


5 posted on 08/27/2021 3:36:58 AM PDT by Travis McGee (EnemiesForeignAndDomestic.com)
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To: MtnClimber

that would explain why so many people have been confused about the approval.

in Australia, those who noted the name - Comirnaty - knew that it was on offer Down Under.

27 Aug: Australian Govt: Therapeutic Goods Association (TGA): COVID-19 vaccine: Pfizer Australia - COMIRNATY BNT162b2 (mRNA) - approved for use in individuals 12 years and older
On 22 July 2021 the Therapeutic Goods Administration (TGA) granted provisional approval to Pfizer Australia Pty Ltd for its COVID-19 vaccine, COMIRNATY, in individuals aged 12 years and older.

This decision follows the provisional approval granted by the TGA to COMIRNATY on 25 January 2021 for used in individuals aged 16 years and older. Pfizer subsequently made an application to the TGA to vary the original approval to include children between 12 and 15 years of age...

Provisional approval of this vaccine is valid for two years and means it can now be legally supplied in Australia. The approval is subject to certain strict conditions, such as the requirement for Pfizer to continue providing information to the TGA on longer term efficacy and safety from ongoing clinical trials and post-market assessment...

Australians can be confident that the TGA’s review process of this vaccine was rigorous and of the highest standard...

The provisional approval pathway provides a formal and transparent mechanism for speeding up the registration of promising new medicines with preliminary clinical data...
https://www.tga.gov.au/covid-19-vaccine-pfizer-australia-comirnaty-bnt162b2-mrna-approved-use-individuals-12-years-and-older

it’s shocking how many Australians believe the TGA independently assesses these vaccines, when they do nothing of the sort.

there is, at present, some concern building about the push to vaccinate 12-15 year olds.


6 posted on 08/27/2021 3:43:42 AM PDT by MAGAthon
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To: MAGAthon

meant to emphasise the following bit:

“Provisional approval of this vaccine is valid for two years”

for me, this “provisional” aspect should be mentioned by those in the media, especially, who push these vaccines 24/7. I would think “provisional” is different from “full approval”??


7 posted on 08/27/2021 3:45:41 AM PDT by MAGAthon
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To: MtnClimber

Thanks for posting this. I have been trying to understand this since the ‘approval’ came out... This is the best explanation I have seen yet, in layman’s terms.


8 posted on 08/27/2021 4:33:36 AM PDT by LegendHasIt
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To: MtnClimber
oday, 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
They are one in the same. No bait and switch.(The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty)as per above. The FDA approved the Pfizer vax for 16+ and that vax has been given a marketing name, Comirnaty. At the same time, they had to revise and re-authorize the EUA usage for 12-15 year olds.
Page 2 para 1 - 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.
Merely reiterating the above announcement but notice the use of biologics license application (BLA)
Page 2 para 2 - 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. https://www.fda.gov/media/150386/download
Simply states that the EUA is being revised and renewed for certain uses that are not included in the approved BLA

There is some fine print that's oddly worded but that could just be a matter of being written by a young flunky

9 posted on 08/27/2021 5:28:38 AM PDT by Pollard (#*&% Communism)
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To: MtnClimber

Bookmark.


10 posted on 08/27/2021 5:31:46 AM PDT by grobdriver
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To: Pollard

So if I go to get my jab today and say, give me the one that’s been fully approved by the FDA, what will they give me?


11 posted on 08/27/2021 5:50:00 AM PDT by Toad of Toad Hall (nunquam minus solus quam cum solus)
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To: MtnClimber

Gee, I wonder what entities Pfizer donates to politically?…

Oh, yeah… they’re big donors to Plugs Biden, the DNC AND the RNC.

No WONDER it is THEIR “vaccine” that got FDA approval…

Yeah..sure.. looks legit to me!


12 posted on 08/27/2021 5:53:45 AM PDT by joethedrummer
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To: Toad of Toad Hall

That’s really the question. And do recipients of the jab sign paperwork? And does the paperwork still contain any language about consent to experimental, unapproved medicine, or anything along those lines?


13 posted on 08/27/2021 5:54:04 AM PDT by ClearCase_guy (We have two Democrat parties. 50% of the US population is taxed w/o representation.)
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To: MtnClimber

They approved the unavailable vax version because if it were available (and effective) all other vaxes under the emergency approval would be instantly illegal.

Pharm cannot have that.

And, that is the precise reason all of the other treatments were demonized when mentioned (e.g. Iverwhatever, HydroIdon’tcare, Zn, etc). Had any doctor been allowed to show that they were effective all of the fake vaccines would be illegal.
Pharm cannot have that.


14 posted on 08/27/2021 6:13:31 AM PDT by bobbo666 (Baizuo)
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To: MtnClimber

I’ve been reading the PREP Act and it’s subsequent amendments.

Especially the particularly infuriating bits about liability coverage being only available for “covered countermeasures”.

That frickin’ explains a lot.


15 posted on 08/27/2021 6:16:25 AM PDT by mewzilla (Those aren't masks. They're muzzles. )
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To: MtnClimber

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.


16 posted on 08/27/2021 6:17:02 AM PDT by AppyPappy (How many fingers am I holding up, Winston? )
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To: bobbo666

“What the FDA approved and licensed is Pfizer’s Comirnaty Covid vaccine not the current Pfizer-BioNTech Covid vaccine in use under an Emergency Use Authorization (EUA). The FDA has acknowledged that Pfizer has insufficient stocks of the newly licensed Comirnaty vaccine available but there is significant amount of the Pfizer-BioNTech Covid vaccine available under the EUA still on hand.”

The media is still confusing the public. This statement in particular. The stock on hand and the Pfizer vax new marketing brand, Comirnaty, that will be produced are exactly the same formulation. It really is not that difficult of a concept to grasp. I don’t care if you are for or against the Pfizer vax. This is not fraud by the gov or Pfizer.


17 posted on 08/27/2021 6:23:51 AM PDT by Oystir
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To: Toad of Toad Hall

Well I doubt they’ve been distributed with the new labeling so just bring a Sharpie and have them write COMIRNATY on the label.


18 posted on 08/27/2021 6:29:55 AM PDT by Pollard (#*&% Communism)
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To: Pollard

My understanding was that the existing doses will be used up under the EUA, and that new doses will fall under the “ full approval”.

https://www.rwmalonemd.com/s/Key-points-to-consider-FDA-letters-and-press-release.pdf

Interesting that since this was written the 8 month boosters became six month boosters.


19 posted on 08/27/2021 6:45:10 AM PDT by dynoman (Objectivity is the essence of intelligence. - Marilyn vos Savant)
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To: Pollard

The switcheroo is not so much about the contents/safety/efficacy of the vaccine, but the legal status.

The current Pfizer vaccine is authorized under EUA and is free from liability. The Comirnaty (Pfizer-BioNTech) vaccine will be fully licensed and not immune from liability.

So....the media is saying that the Pfizer vaccine is fully approved so that people can feel better about getting the jab. However, they’ll be getting it under the EUA and will not have any recourse if injured.

Comirnaty won’t be available for many months if not a year or more, meaning that the vast majority of Americans will receive the vaccine under the EUA and have no legal recourse, but thanks to the media they will be under the impression that they are taking a approved vaccine.

Bait and Switch with cover provided by our government and media.

Also consider that this approval was still fast tracked with several steps being skipped in the normal process. Public commentary being one, where the FDA suggested there was no controversy over the vaccine, so no need for public comment. SURE.

Take all in to consideration before becoming a test monkey.


20 posted on 08/27/2021 7:25:17 AM PDT by Andrewksu
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