Expert says 'FDA-approved' Pfizer shot is NOT what people have been getting

[Elderberry]

WND by Bob Unruh 8/25/2021

Claims feds are playing 'little trick' between 'two separate vaccines'

In a much-trumpeted announcement this week the Food and Drug Administration said it was approving for general use the Pfizer COVID-19 vaccine.

Americans have been getting Pfizer shots for months already, under an emergency use authorization.

But an expert in the field says what reports have failed to include is that the vaccine approved by the FDA is not the same as the one that's already been in use.

It is Dr. Robert Malone who said during an interview on "The Warroom with Steve Bannon" that the vaccines are similar, but not the same.

Bannon asked, is the "authorized" vaccine now ready to be administered to patients?

"It's absolutely not available," Malone explained. "The little trick that they've done here is that they've issued two letters, separate letters for two separate vaccines. The Pfizer vaccine which is what is currently available, is still under emergency use authorization, and it still has the liability shield."

He said, "The product that's licensed is the BioNTech product which is substantially similar but not necessarily identical. It's called Comirnaty … and it's not yet available. They haven't started manufacturing it or labeling it and that's the one that the liability waiver will no longer apply."

He said. "So the one that's actually licensed is not yet available and when it does become available it will no longer have the liability shield."

More: https://www.wnd.com/2021/08/stunner-expert-says-fda-approved-pfizer-shot-not-people-getting/

[Kamaji]

Total nonsense.

The FDA didn't issue separate letters for separate vaccines.  They issued one letter granting full approval of the Biologics License Application for use of the vaccine on people 16 years and older, and granted approval for Pfizer to label the product with the proprietary name "Comirnaty".  They then re-issued the original emergency use authorization letter, with amendments, allowing the vaccine to be used under emergency authority (i.e., without prior full approval) for people who are between the ages of 12 and 15.

Full BLA Approval letter:  https://www.fda.gov/media/151710/download

Revised, re-issued EUA letter:  https://www.fda.gov/media/150386/download

As to the exact nature of the same underlying substance granted approval in each letter, the re-issued EUA states as follows:

Pfizer-BioNTech COVID‑19 Vaccine contains a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 formulated in lipid particles. COMIRNATY (COVID-19 Vaccine, mRNA) is the 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.

To be quite honest, there are enough legitimate issues with the vaccine, the decisions - personal and political - about whether to mandate vaccination, and etc, that are getting obscured, and inadequately considered and discussed, because of the fear pron and outright gaslighting that is coming from both sides of the argument.

[PeteS in CA]

Pig manure! Malone has never worked for BioNTech or Pfizer (or Moderna). Has he even worked on an mRNA vaccine in this century? Or ever? He has little more clue to the contents of Pfizer's vaccine than I do.

"Comirnaty" is Pfizer's now-approved trade name for "BNT162b2", the vaccine developed by BioNTech and tested in the US in partnership with Pfizer, not something different.

The Pfizer Covid vaccine is now fully approved by the FDA for use with people age 16 and older. It is officially no longer "experimental", though anti-vaxxers and anti-Covid-vaxxers are still free to call it a ham sandwich if that amuses them.

The Pfizer Covid vaccine is still used under Emergency Use Authorization for youths ages 12-15 (which was authorized several months ago). However, the rolling process leading to the biologics license being extended to include 12-15YO has begun.

The Bogey-Moderna cometh!

[PeteS in CA]

Total nonsense.
...

I don't look in on WND (World Net Daily), but when I come across something that sounds interesting from WND I usually look to see if its claims hold up to fact-checking. WND may be better than the average clickbait site, , but not by a lot.

[Elderberry]

Did the FDA Pull a Bait-and-Switch on the American People?

American Thinker by Steve McCann 8/26/2021

https://www.americanthinker.com/articles/2021/08/did_the_fda_pull_a_baitandswitch_on_the_american_people.html

See also: The FDA did NOT grant full approval to the Pfizer shots

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.

But what the agitprop media and the Biden White House failed to report is that there are two critical issues as to whether the Pfizer-BioNTech Covid vaccine (which is what has been and continues to be administered) can be mandated and whether Pfizer can be held liable for injuries, a provision that accompanies permanent approval of a vaccine or drug.

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.

Further, the FDA decreed that the Pfizer-BioNTech vaccine should remain unlicensed and under the EUA but can be used interchangeably with the newly licensed Comirnaty vaccine.  More importantly, the FDA states that the licensed Comirnaty vaccine and the existing Pfizer-BioNTech vaccine are “legally distinct” but proclaims that their differences do not “impact safety or effectiveness.” [emphases added]

More at link.

[Kamaji]

No, they did not.

[PeteS in CA]

Repeated posts of the same pig-manure lies from different sources can't make the lies true.

But fine. Let's look at the FDA Approval letter, https://www.fda.gov/media/151710/download . Here is page 1 and a bit of page 2 of the letter:

Our STN: BL 125742/0 BLA APPROVAL
BioNTech Manufacturing GmbH August 23, 2021
Attention: Amit Patel
Pfizer Inc.
235 East 42nd Street
New York, NY 10017
Dear Mr. Patel:
Please refer to your Biologics License Application (BLA) submitted and received on
May 18, 2021 1, under section 351(a) of the Public Health Service Act (PHS Act) for
COVID-19 Vaccine, mRNA.
LICENSING
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
w ww.fda.gov
We are issuing Department of Health and Human Services U.S. License No. 2229 to
BioNTech Manufacturing GmbH, Mainz, Germany, under the provisions of section
351(a) of the PHS Act controlling the manufacture and sale of biological products. The
license authorizes you to introduce or deliver for introduction into interstate commerce,
those products for which your company has demonstrated compliance with
establishment and product standards.
Under this license, you are authorized to manufacture the product, COVID-19 Vaccine,
mRNA, which is indicated for active immunization to prevent coronavirus disease 2019
(COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
in individuals 16 years of age and older.
The review of this product was associated with the following National Clinical Trial
(NCT) numbers: NCT04368728 2 and NCT04380701 3.
MANUFACTURING LOCATIONS
Under this license, you are approved to manufacture COVID-19 Vaccine, mRNA drug
substance at
 The final formulated product will be manufactured, filled,
labeled and packaged at Pfizer
. The diluent, 0.9% Sodium Chloride Injection, USP, will be manufactured at
(b) (4) (b) (4)
(b) (4)
Page 2 – STN BL 125742/0 – Elisa Harkins
You may label your product with the proprietary name, COMIRNATY 4, and market it in
2.0 mL glass vials, in packages of 25 and 195 vials.
We did not refer your application to the Vaccines and Related Biological Products
Advisory Committee because our review of information submitted in your BLA, including
the clinical study design and trial results, did not raise concerns or controversial issues
that would have benefited from an advisory committee discussion.

1 For what did Pfizer and BioNTech apply for a biologics license? https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-initiate-rolling-submission-biologics , https://investors.biontech.de/news-releases/news-release-details/pfizer-and-biontech-initiate-rolling-submission-biologics . The application was for the Pfizer/BioNtech vaccine BNT162b2.

2 What was tested in National Clinical Trial NCT04368728? https://clinicaltrials.gov/ct2/show/NCT04368728 . Pfizer/BioNtech vaccine BNT162b2.

3 What was tested in National Clinical Trial NCT04380701? https://clinicaltrials.gov/ct2/show/NCT04380701 . Pfizer/BioNtech vaccine BNT162b2.

4 "Comirnaty" is the FDA-approved proprietary name for Pfizer/BioNtech vaccine BNT162b2, not something different.

[PeteS in CA]

Why are anti-Covid-vaxxers having to resort to lies this stupid?

Why are anti-Covid-vaxxers gaming people's fears and confirmation biases with stupid lies like this one?

[jmyrlefuller]

Why are anti-Covid-vaxxers having to resort to lies this stupid?

Why are anti-Covid-vaxxers gaming people's fears and confirmation biases with stupid lies like this one?

The only thing I can think of is that they're exploiting the gullible to discredit the legitimate criticism of the vaccine.

There are legitimate concerns about this being rushed, and the rapidly diminishing efficacy. But there is very little talk of that among the anti-vax crowd, instead it's all focused on red herrings seemingly made up out of thin air.

[Kamaji]

The only thing I can think of is that they're exploiting the gullible to discredit the legitimate criticism of the vaccine.

There are legitimate concerns about this being rushed, and the rapidly diminishing efficacy. But there is very little talk of that among the anti-vax crowd, instead it's all focused on red herrings seemingly made up out of thin air.

Agreed.  There are definitely legitimate concerns with the vaccines, and it is annoying that those legitimate concerns are being drowned out with silliness.

[LegalAmerican]

WND by Bob Unruh 8/25/2021

Claims feds are playing 'little trick' between 'two separate vaccines'

In a much-trumpeted announcement this week the Food and Drug Administration said it was approving for general use the Pfizer COVID-19 vaccine.

Americans have been getting Pfizer shots for months already, under an emergency use authorization.

But an expert in the field says what reports have failed to include is that the vaccine approved by the FDA is not the same as the one that's already been in use.

It is Dr. Robert Malone who said during an interview on "The Warroom with Steve Bannon" that the vaccines are similar, but not the same.

Bannon asked, is the "authorized" vaccine now ready to be administered to patients?

"It's absolutely not available," Malone explained. "The little trick that they've done here is that they've issued two letters, separate letters for two separate vaccines. The Pfizer vaccine which is what is currently available, is still under emergency use authorization, and it still has the liability shield."

He said, "The product that's licensed is the BioNTech product which is substantially similar but not necessarily identical. It's called Comirnaty … and it's not yet available. They haven't started manufacturing it or labeling it and that's the one that the liability waiver will no longer apply."

He said. "So the one that's actually licensed is not yet available and when it does become available it will no longer have the liability shield."

More: https://www.wnd.com/2021/08/stunner-expert-says-fda-approved-pfizer-shot-not-people-getting/

TRUE. TRUE.   

[LegalAmerican]

Total nonsense.

The FDA didn't issue separate letters for separate vaccines.  They issued one letter granting full approval of the Biologics License Application for use of the vaccine on people 16 years and older, and granted approval for Pfizer to label the product with the proprietary name "Comirnaty".  They then re-issued the original emergency use authorization letter, with amendments, allowing the vaccine to be used under emergency authority (i.e., without prior full approval) for people who are between the ages of 12 and 15.

Full BLA Approval letter:  https://www.fda.gov/media/151710/download


Revised, re-issued EUA letter:  https://www.fda.gov/media/150386/download

As to the exact nature of the same underlying substance granted approval in each letter, the re-issued EUA states as follows:

To be quite honest, there are enough legitimate issues with the vaccine, the decisions - personal and political - about whether to mandate vaccination, and etc, that are getting obscured, and inadequately considered and discussed, because of the fear pron and outright gaslighting that is coming from both sides of the argument.

Sorry.  You still believe what government says?   We are not America anymore..as you once knew it.  O.P. is correct.

[mountaineer]

Major law firm confirms FDA deceived America with its ‘approval’ of Pfizer vax
Published on September 6, 2021
Written by leohohmann.com

When the U.S. Food and Drug Administration announced Aug. 23 it had granted full approval to the first Covid “vaccine” under the brand name Comirnaty, the mainstream media immediately ran with the narrative.

Joe Biden jumped in front of a microphone and told businesses they needed to “step up” the mandating of vaccines for their employees.

Dr. Anthony Fauci told national media outlets he expected a whole host of new “mandates” to be fueled by the “approval” of the Pfizer jab.

There’s only one problem. The “approval” given by the FDA was not for the Pfizer jab currently available in the U.S. market. ...

Principia-Scientific

[PeteS in CA]

Repeated posts of the same pig-manure lies from different sources can't make the lies true.

But fine. Let's look at the FDA Approval letter, https://www.fda.gov/media/151710/download . Here is page 1 and a bit of page 2 of the letter:

Our STN: BL 125742/0 BLA APPROVAL
BioNTech Manufacturing GmbH August 23, 2021
Attention: Amit Patel
Pfizer Inc.
235 East 42nd Street
New York, NY 10017
Dear Mr. Patel:
Please refer to your Biologics License Application (BLA) submitted and received on
May 18, 2021 1, under section 351(a) of the Public Health Service Act (PHS Act) for
COVID-19 Vaccine, mRNA.
LICENSING
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
w ww.fda.gov
We are issuing Department of Health and Human Services U.S. License No. 2229 to
BioNTech Manufacturing GmbH, Mainz, Germany, under the provisions of section
351(a) of the PHS Act controlling the manufacture and sale of biological products. The
license authorizes you to introduce or deliver for introduction into interstate commerce,
those products for which your company has demonstrated compliance with
establishment and product standards.
Under this license, you are authorized to manufacture the product, COVID-19 Vaccine,
mRNA, which is indicated for active immunization to prevent coronavirus disease 2019
(COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
in individuals 16 years of age and older.
The review of this product was associated with the following National Clinical Trial
(NCT) numbers: NCT04368728 2 and NCT04380701 3.
MANUFACTURING LOCATIONS
Under this license, you are approved to manufacture COVID-19 Vaccine, mRNA drug
substance at
 The final formulated product will be manufactured, filled,
labeled and packaged at Pfizer
. The diluent, 0.9% Sodium Chloride Injection, USP, will be manufactured at
(b) (4) (b) (4)
(b) (4)
Page 2 – STN BL 125742/0 – Elisa Harkins
You may label your product with the proprietary name, COMIRNATY 4, and market it in
2.0 mL glass vials, in packages of 25 and 195 vials.
We did not refer your application to the Vaccines and Related Biological Products
Advisory Committee because our review of information submitted in your BLA, including
the clinical study design and trial results, did not raise concerns or controversial issues
that would have benefited from an advisory committee discussion.

1 For what did Pfizer and BioNTech apply for a biologics license? https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-initiate-rolling-submission-biologics , https://investors.biontech.de/news-releases/news-release-details/pfizer-and-biontech-initiate-rolling-submission-biologics . The application was for the Pfizer/BioNtech vaccine BNT162b2.

2 What was tested in National Clinical Trial NCT04368728? https://clinicaltrials.gov/ct2/show/NCT04368728 . Pfizer/BioNtech vaccine BNT162b2.

3 What was tested in National Clinical Trial NCT04380701? https://clinicaltrials.gov/ct2/show/NCT04380701 . Pfizer/BioNtech vaccine BNT162b2.

4 "Comirnaty" is the FDA-approved proprietary name for Pfizer/BioNtech vaccine BNT162b2, not something different.

[LadyLiberty]

4 "Comirnaty" is the FDA-approved proprietary name for Pfizer/BioNtech vaccine BNT162b2, not something different.

No different than generic ibuprofen vs Motryn or Advil ... or ezetimibe vs Zetia, etc etc etc.

[PeteS in CA]

Or Oxford–AstraZeneca COVID-19 vaccine

https://en.wikipedia.org/wiki/Oxford%E2%80%93AstraZeneca_COVID-19_vaccine

The Oxford–AstraZeneca COVID-19 vaccine, codenamed AZD1222, and sold under the brand names Covishield and Vaxzevria among others ...

Or Remdesivir

https://en.wikipedia.org/wiki/Remdesivir

Remdesivir, sold under the brand name Veklury, is a broad-spectrum antiviral medication developed by the biopharmaceutical company Gilead Sciences.