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FDA memoryholes original Comirnaty letter indicating Pfizer-BioNTech COVID-19 is not same
Wayback Machine ^ | 8/23/2021 | FDA

Posted on 10/13/2021 5:16:49 PM PDT by No.6

http://web.archive.org/web/20210922125540/https://www.fda.gov/media/150386/download Original text of 8/22 letter: “COMIRNATY (COVID-19 Vaccine, mRNA) is now licensed for individuals 16 years of age and older. There remains, however, a significant amount of PfizerBioNTech COVID-19 vaccine that was manufactured and labeled in accordance with this emergency use authorization. This authorization thus remains in place with respect to that product for the previously-authorized indication and uses (i.e., for use to prevent COVID-19 in individuals 12 years of age and older with a two-dose regimen, and to provide a third dose to individuals 12 years of age or older who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise).”

(Excerpt) Read more at web.archive.org ...


TOPICS: Culture/Society; Government
KEYWORDS: comirnaty; covid19; fda; pfizer
On 9/22, FDA removed this letter entirely and swapped in a new letter at the same URL: https://www.fda.gov/media/150386/download This now reads: "COMIRNATY (COVID-19 Vaccine, mRNA) is the same formulation as the Pfizer-BioNTech COVID-19 Vaccine and can be used interchangeably with the Pfizer-BioNTech COVID-19 Vaccine to provide the COVID-19 vaccination series.10"

The new one clearly is written to state that one and the other are equal and interchangable, except of course they aren't as the original letter, so trumpeted by the media and vax-shills everywhere, states.

Thus the old goes away, the new slots into the same URL, and except for people like U.S. Senators (https://www.foxnews.com/media/ron-johnson-no-fda-approved-covid-vaccine) we're supposed to all believe that they are and always were the same.

1 posted on 10/13/2021 5:16:49 PM PDT by No.6
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To: No.6

And the consequence?


2 posted on 10/13/2021 5:19:44 PM PDT by whistleduck
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To: No.6

The FDA should have a WARNING LABEL that it lies,
that it hates Americans and the US Constitution,
that it ignores fatalities and morbidities IF PAID OFF.


3 posted on 10/13/2021 5:26:34 PM PDT by Diogenesis (Si vis pacem, para bellum)
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Source of FDA's letter about Comirnaty:

http://web.archive.org/web/20210922125540/https://www.fda.gov/media/150386/download

The FDA's full letter (.pdf) converted to HTML and posted to FR at the link for safe keeping:

FDA: original Comirnaty letter indicating Pfizer-BioNTech COVID-19 is not same

4 posted on 10/13/2021 5:45:38 PM PDT by ransomnote (IN GOD WE TRUST)
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To: No.6

If so, why is the EUA still in effect?


5 posted on 10/13/2021 6:21:27 PM PDT by Mygirlsmom (Back after a long hiatus. Now mygrandkidsgrandma)
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To: ransomnote

10/13/21 - MY SECOND PHONE CALL WITH PFIZER ABOUT FDA APPROVAL — SPOILER: IT’S NOT APPROVED

https://www.bitchute.com/video/pxp90rE5Pttx/


6 posted on 10/13/2021 6:27:15 PM PDT by LilFarmer
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To: No.6

My gauge is that this is the same formulation, but simply that the older ones are under EUA and cannot be upgraded.

Of course, notice the age difference between EUA and approval.

Either way, this is a good reason to defy the Pfizer shots.


7 posted on 10/13/2021 6:32:32 PM PDT by the OlLine Rebel (Common sense is an uncommon virtue./Federal-run medical care is as good as state-run DMVs.)
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To: No.6

Can’t seem to see more than. One page. And, curiously, this is a letter to someone. Why? Shouldn’t it be just a document, a report, a statement?


8 posted on 10/13/2021 6:43:43 PM PDT by the OlLine Rebel (Common sense is an uncommon virtue./Federal-run medical care is as good as state-run DMVs.)
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To: No.6

When Hillary Rodham married Bill Clinton and became Hillary Clinton… was she still the same person?


9 posted on 10/13/2021 6:44:57 PM PDT by House Atreides
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To: No.6

FDA claims “same formulation”.

That appears to be less than identical. So exactly what are all the differences?


10 posted on 10/13/2021 7:42:38 PM PDT by Triple (Socialism denies people the right to the fruits of their labor, and is as abhorrent as slavery)
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To: No.6

Glad I downloaded it to my phone. I knew those sockcuckers would do something like this.


11 posted on 10/13/2021 8:40:15 PM PDT by Prince of Space ( Let’s go, Brandon! )
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To: Prince of Space

If possible, requesting that you please repost these items, to bring the largest number of persons aware. Thank you.


12 posted on 10/13/2021 11:43:55 PM PDT by Norski (Tolerance becomes a crime when applied to evil. - Thomas Mann)
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To: No.6

Sounds like Comirnaty “vaccine” can be substituted for PfizerBNTCovid19 “vaccine” under the latter’s EUA, but nowhere does it say PfizerBNTCovid19 “vaccine” can be used as a fully licensed product.

Comirnaty isn’t available to US consumers, and I’m guessing Pfizer will keep it that way as long as possible. They wouldn’t want to be liable for the side affects. Dispensing only the EUA product in the US, they remain immune to liability.


13 posted on 10/19/2021 6:14:27 PM PDT by Tellurian (Your phone is your cattle tag. 2/4/2004: DARPA Lifelog terminated, MZ Facebook initiated. )
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To: ransomnote

I hate to be the sole person to notice and tell you this, but that ‘original letter’ has like language (”same formulation as the PfizerBioNTech COVID-19 Vaccine and can be used interchangeably with the Pfizer-BioNTech COVID-19 Vaccine to provide the COVID-19 vaccination series”).

I looked weeks ago and could never find an ‘original’ letter with different language (I did try).


14 posted on 11/12/2021 6:07:13 PM PST by logi_cal869 (-cynicus the "concern troll" a/o 10/03/2018 /!i!! &@$%&*(@ -)
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To: logi_cal869

did you read the footnote?

original letter was more specific.


15 posted on 11/12/2021 6:11:26 PM PST by rolling_stone
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To: logi_cal869

I hate to be the sole person to notice and tell you this, but that ‘original letter’ has like language (”same formulation as the PfizerBioNTech COVID-19 Vaccine and can be used interchangeably with the Pfizer-BioNTech COVID-19 Vaccine to provide the COVID-19 vaccination series”).

I looked weeks ago and could never find an ‘original’ letter with different language (I did try).
~~~~~~~~~~~~~
The original letter did exist. The scrubbing is that good. We probably captured the original in other posts, threads on FR. There were analyses by known experts explaining why the original letter indicates the shell game in play. I just am not sure what tiles to look for.


16 posted on 11/12/2021 8:06:37 PM PST by ransomnote (IN GOD WE TRUST)
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To: ransomnote

This letter - which I’ve not seen prior - has some interesting language:

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


17 posted on 11/12/2021 9:04:52 PM PST by logi_cal869 (-cynicus the "concern troll" a/o 10/03/2018 /!i!! &@$%&*(@ -)
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To: logi_cal869
In the News/Activism forum, on a thread titled FDA memoryholes original Comirnaty letter indicating Pfizer-BioNTech COVID-19 is not samelogi_cal869 wrote:

This letter - which I’ve not seen prior - has some interesting language:

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

Our enemies are really are scrubbing the Internet free of evidence that the Pfizer Covid 'vaccine' now in use is under EUA and is not the same as the Comirnaty vaccine which has not yet been manufactured, and is not scheduled to be manufactured anytime soon, based on recent reports.

The legal distinction, referred to in your FDA link, which does not impact 'safety and effectiveness' is that Covid-19 is Emergency Use Authorized (no liability), and Comirnaty is FDA approved (liability). So it's not truthful for the MSM/CDC et. al to say they are interchangeable when one is experimental and exempt from liability and the other is rubber-stamped FDA approved and entails the right for patients to seek compensation for horrific, long-lasting side effects.

 

18 posted on 11/12/2021 10:19:50 PM PST by ransomnote (IN GOD WE TRUST)
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To: ransomnote

Agreed.


19 posted on 11/12/2021 10:22:12 PM PST by logi_cal869 (-cynicus the "concern troll" a/o 10/03/2018 /!i!! &@$%&*(@ -)
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To: No.6
This letter still includes the following:

Pfizer Inc. will supply Pfizer-BioNTech COVID‑19 Vaccine either directly or through authorized distributor(s), 19 to emergency response stakeholders20 as directed by the U.S. government, including the Centers for Disease Control and Prevention (CDC) and/or other designee, for use consistent with the terms and conditions of this EUA;
It also includes the footnote 17 (used to be footnote 12):

Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA. Additionally, there are no COVID-19 vaccines that are approved to provide: COVID-19 vaccination in individuals 5 through 15 years of age; a third primary series dose to certain immunocompromised populations described in this EUA; a homologous booster dose to the authorized population described in this EUA; or a heterologous booster dose following completion of primary vaccination with another authorized COVID-19 vaccine.

Therefore, the currently offered vaccines are still covered by the terms of the EUA, which includes the legal right to opt out due to informed consent.

-PJ

20 posted on 11/12/2021 11:07:23 PM PST by Political Junkie Too ( * LAAP = Left-wing Activist Agitprop Press (formerly known as the MSM))
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