FDA/Media Shell Game: Pfizer ‘Vaccine’ Was Not Approved After All

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In just 24 hours, the mainstream media complex has been flooded with the headline “Full Approval!” for the Pfizer gene therapy injection. Let the vaccine mandates begin!

Anthony Fauci is thrilled over this news, stating, “you’re gonna see a lot more [vaccine] mandates because there will be institutions and organizations which previously were reluctant to require vaccinations, which will now feel much more empowered to do that.” 

But wait. Something is not adding up with this new stampede to get the needle into your arm.

First, the drug giant Pfizer did not directly develop its mRNA shot: it hired a German company in 2018, BioNTech, to do that for them. They subsequently entered into a joint marketing/manufacturing agreement to deliver the resulting product to the world. Thus BioNTech is not a subsidiary of Pfizer. According to their joint 2018 press release, we learn that:

“Under the terms of the agreement, BioNTech and Pfizer will jointly conduct research and development activities to help advance mRNA‐based flu vaccines. Pfizer will assume sole responsibility for further clinical development and commercialization of mRNA‐based flu vaccines, following BioNTech’s completion of a first in human clinical study.”

The latter human clinical study is what was delivered to the FDA for evaluation, on behalf of BioNTech, in order to get FDA “approval”. BioNTech named the shot Comirnaty. Pfizer has not conducted its own trial, much less submitted it to the FDA.

Because of the contractual development agreement between the two companies, it is unclear that the BioNTech shot is identical to whatever Pfizer is distributing in America, or anywhere else, for that matter. Nevertheless, the media and the FDA promote Pfizer/BioNTech without making any distinctions between the two.

What was “approved” by the FDA on Monday (8/23) was Comirnaty, which belongs to the BioNTech side of the Pfizer/BioNTech working agreement.

In other words, Pfizer is not even in the picture for approval and continues to sell its version of the shot under the Emergency Use Authorization. To repeat, Pfizer has no approval for any mRNA vaccine.

Now, there are a boatload of problems with BioNTech’s application and the FDA’s treatment of it. Medical experts who are examining BioNTech’s human clinical study are quite alarmed. I don’t want to address those issues here, but a detailed analysis is forthcoming.

This report will only point out the duplicitous behavior of the FDA and the mainstream media in promoting this falsehood that Pfizer’s shot has full FDA approval.

To that end, I located the FDA’s official press release dated August 23, 2021 that was titled, “FDA Approves First COVID-19 Vaccine.” We can give them credit for getting the title correct, but the rest of the text is convoluted. We only need to look at the first paragraph to see what has happened:

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. [emphasis added]

To say that the “vaccine has been known as” is not a specific name designated by the FDA or anyone else. It should be BioNTech only because they hold the product name Comirnaty. To be clear, Comirnaty has received FDA approval.

In the next sentence, the FDA says “The vaccine also continues to be available under emergency use authorization (EUA)” Do you see that they are talking about two separate products? The second instance belongs to Pfizer and the former to BioNTech. The Pfizer shot is NOT approved and continues as before under EUA.

There is another distinctive that proves this point. Comirnaty is approved for individuals 16 years of age and older. The EUA drug is authorized for individuals 12 through 15.

Lastly, the approval letter sent from the FDA to Pfizer states in footnote 8,

“The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness. [emphasis added]

The “certain differences” are not specified, but it is perfectly clear that the two jabs are legally distinct.

The FDA and Pfizer have just played a shell game that leads the world to think that the Pfizer drug has been approved, but it clearly has not! This obfuscation, if not outright deception, belongs at the feet of the Food & Drug Administration. Nevertheless, the entire nation is swooning over vaccine mandates from every conceivable quarter. Furthermore, the confusion is being reinforced by Dr. Anthony Fauci and his merry band of medical Technocrats who are quite certain that the end justifies the means.

 

 

 

 

About the Author

Patrick Wood
Patrick Wood is a leading and critical expert on Sustainable Development, Green Economy, Agenda 21, 2030 Agenda and historic Technocracy. He is the author of Technocracy Rising: The Trojan Horse of Global Transformation (2015) and co-author of Trilaterals Over Washington, Volumes I and II (1978-1980) with the late Antony C. Sutton.
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John

Thanks for clarifying this game of 3-card Monty!

nail

He is retarded.; Look on the FDA site. Pfizer changed the name of the vax. These ppl are lunatics as you are if you believe this shit.

Jeff

I’m not sure I agree on this. From the “official press release” link:
Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.

I would guess this is where the distinction can be made?
Because of the contractual development agreement between the two companies, it is unclear that the BioNTech shot is identical to whatever Pfizer is distributing in America, or anywhere else, for that matter. Nevertheless, the media and the FDA promote Pfizer/BioNTech without making any distinctions between the two.

Damian

They may have the same formulation, but it doesn’t make them the same product, as the FDA clearly state themselves: ‘with certain differences that do not impact safety or effectiveness’.

Elle

Yes. And no matter how the FDA document reads the FakeSM will push it as truth and people will believe it–true or false.

Jane Doe

Jeff, you can print both letters:

Currently distributed jab – under EUA:
https://www.fda.gov/media/150386/download

Comirnaty – under BLA only
https://www.fda.gov/media/151710/download

If u read both letters carefully, you will see the shell game they are playing.

Patrick is 100% right about this.

Vickie Zaccardo

Agree. The FDA site specifically says ‘ formerly known as’ now being called Comirnaty. There is zero indication that BioNTech made a seperate shot. Where are the controlled studies?

nail

He is retarded.; Look on the FDA site. Pfizer changed the name of the vax. These ppl are lunatics as you are if you believe this shit.

snowdog

I still need to read the FDA download docs linked on this page, but I don’t see what the author sees. The paragraph cited from the FDA press release mentions that the vaccine technically approved, and also still EUA authorized, and EUA also authorizes the vaccine for younger people. The citation from the approval letter footnote 8 mentions “certain differences” that don’t affect safety or effectiveness. These undisclosed differences could be in product packaging, ship kits, labelling, refrigeration materials, etc., and not the actual biologic itself. FDA is highly interested in all of that, in addition to the actual product.… Read more »

Bob

Nothing the Synagogue of satan foes can be trusted,
Revelation 2:9 and 3:9

[…] I also include this summary from Technocracy News: FDA/Media Shell Game: Pfizer ‘Vaccine’ Was Not Approved After All (technocracy.news) […]

Damian

Dear Patrick,
Are you sure about this? Because if you are, then they are boldly lying..
Don’t they mean that it’s the same vaccine that is now officially approved for 16 years and older, but not approved (however, still authorized) for 12-15 years?
I guess to be completely sure they would have to include all vaccines that are only authorized in a separate list, not just the list with the completely approved ones. But they don’t seem to display such a list, making it quite difficult to gather accurate information.

Patrick Wood

The approval letter states, “The products are legally distinct with certain differences that do not impact safety or effectiveness.“

Refusenick

The legal distinction is that cominarty doesn’t have the liability waiver that the prizes shot has (because it’s not EUA). This is a PR stunt to encourage mandates of the indemnified Phizer shot by pretending it’s the unindemnified cominarty shot.

Irene

It also says:

“The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns”

So this “approval” is very confusing. In addition, I don’t know how they can say and truly believe that these shots are “…without presenting any safety or effectiveness concerns”. I strongly believe they do present a hugh safety concern.

Last edited 29 days ago by Irene Waller
Polly

its their effectiveness I am concerned about. There is not a drug on the market that does not pose zero threat to anyone. There are always a small number of people who have adverse effects. The wording says “for the prevention of Covid-19 disease” IT DOES NOT prevent covid in anyone. That has been well established at this point. This shot is a worst case scenario. It creates millions of asymptomatic positive super spreaders and a false sense of security.

Damian

Thanks, Patrick. I went over your article too fast. Meanwhile I figured it out too.

sharon a

The cabal has been “boldly lying” for some time now….why stop now when you’re on a roll?
Maybe another sleight of hand magic trick? …Or…Maybe a bait and switch? Deception is their game.

Damian

True, but the FDA can not permit themselves a bold lie. Hence this tricky press statement which can be read in multiple ways. I’m sure their team of legal experts helped them formulate it in a way that is deceptive but they can still get away with.

Vickie Zaccardo

That is my understanding. If BioNTech made a seperate drug, where are the studies? I want to see them. Believing anything from any of these criminals is beyond difficult.

[…] Quelle: FDA/Media Shell Game: Pfizer ‚Vaccine‘ Was Not Approved After All […]

webtrekker

“FDA Approves First COVID-19 Vaccine.” We can give them credit for getting the title correct

No credit from me. It’s not a ‘vaccine’ by any stretch of the imagination!

Elle

I think I read somewhere (correct me if I’m wrong) that Fauci had the FDA definition of a ‘vaccine’ changed so he could continue his imagined ride to historical greatness (spit-spit) via the genocide of humanity.

[…] QUELLE: FDA/MEDIA SHELL GAME: PFIZER ‘VACCINE’ WAS NOT APPROVED AFTER ALL […]

Cam

You can’t just tease us Patrick with a caveat about the medical experts being alarmed with what they are discovering. We need at least a snippet of what’s to come! Great article btw 🙂

Marilynne
sharon a

Interesting link. Jon is basically saying it’s more a “label” game. Commenter D. Pluth alludes to this also.
According to Jon, if the Vial is labeled Pfizer it’s the “old version” still under EUA.
You need to see the vial and you can try and attempt to refuse that vial because it’s still under Emergency Use Authorization. You may buy more time?
The “new” labelled Comirnaty is FDA approved but hasn’t been produced yet under that LABEL and therefore does not yet exist….but for how long?
Basically, We are now witnessing the “devilution” of the US and western societies.

Kriss

Thanks for clarifying this there have been so many conflicting statements even from vaccine-danger watch sites.

Farmer

Thanks Patrick! shared!

Dick Pluth

This means if your company demands you take the jab demand to see the vial and if it is the Pfizer they cannot force you to take it under the EUA.

Gary

Time for a court case seeking a restraining order given the confusion and misinformation!

Victoria

It is hard to imagine that there can be that level of evil… but one only has to remember that in the Bible it says… he was created from his father below and you were created from your Father above. Also, another quote, “My people suffer from the lack of knowledge.” I would like to add, knowledge without action still leaves one in peril…

Jane

Also: ‘August 23, 2021 – ‘The FDA should demand adequate, controlled studies with long term follow up, and make data publicly available, before granting full approval to covid-19 vaccines’ Peter Doshi, senior editor, The BMJ. (British Medical Journal): ‘I reiterate our call: “slow down and get the science right—there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.” FDA should be demanding that the companies complete the two year follow-up, as originally planned (even without a placebo group, much can still be learned about safety). They should demand adequate, controlled studies using patient outcomes in the now… Read more »

gregory alan johnson

Wrong. From the 8/23/2021 FDA Fact Sheet: “The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 12 years of age and older and to provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise. COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. It is approved as a 2-dose series for the prevention of COVID-19 in individuals 16… Read more »

Nikki

You are absolutely correct Patrick! It’s more trickery. People will foolishly continue to get injected with the EUA product which is under the liability shield while the approved product that DOES NOT have the liability shield is not even yet available. They operate on lies and deception. Why would they stop now when they believe they can get more shots into more arms this way? Pure, undiluted evil is behind this. We all need to fully grasp what we are facing right now.

gregory alan johnson

My info comes from the FDA’s own pdf’s off of their site. The Fact Sheet for usage in medical facilities and the LOA letter to Elisa Harkins of Pfizer. The same formulation is used for both Comirnaty (Approved for 16+) and EUA (12-15). Both pdf’s state such. From the LOA to Pfizer, same day (pgs 11-12): “Conditions Related to Printed Matter, Advertising, and Promotion: Y. All descriptive printed matter, advertising, and promotional material relating to the use of the Pfizer-BioNTech COVID‑19 Vaccine clearly and conspicuously shall state that: This product has not been approved or licensed by FDA, but has… Read more »

C Bell

They’re clearly just talking about the difference between the “generic” version of the vaccine vs the “branded”. It’s common practice within the pharmaceutical industry. The “branded” version was approved for those 16 and over, but since the safety and effectiveness for those under 16 and for the booster are yet to be determined, those will still get the generic under the EUA (even though they’re the same vaccine in essence).

Elle

I’ve read a couple of breakouts of the details and it looks to me like they are covered under the FDA document however twisted it all appears to be.

Think we need an experienced lawyer to re-read and determine the details. It’s most important to those who are being forced to take gene therapy to keep their job.

And kids? That’s a bad bag of snakes to lay out.

[…] FDA/Media Shell Game: Pfizer ‘Vaccine’ Was Not Approved After All […]

[…] FDA/Media Shell Game: Pfizer ‘Vaccine’ Was Not Approved After All […]

Victor

Patrick, thank you for clarifying this distinction, looks like the FDA isn’t telling us how the Finezer (the company with the long and recent history of regulatory malfeasance and revolving door corruption of failed and lethal drugs still on market) and BIONICTECH are distinct. No surprise since they have refused to release some of their trials data. But this part really caught my attention. Section I. B. to quote the FDA or FDA director who allegedly signed this doc. “it is reasonable to believethat Pfizer-BioNTech COVID‑19 Vaccine may be effective in preventing COVID-19” So it all comes down to PERSONAL… Read more »

Jane Doe

Could someone tease out the exact drug names and patent numbers for the products in question?

https://www.nature.com/articles/s41587-021-00912-9.pdf

Vickie Zaccardo

This does ‘ not’ make things any cleater. The Pfizer controlled study was the Pfizer BioNTech. BioNTech sponsored Pfizer. Dr. David Martin announced a month or more ago that there was trouble in patent and licensing land. However, this does not mean that there was a seperate COVID shot made by BioNTech. The articles from the FDA website indicate that they have simply relabled the name of the drug for marketing. So while I fully hope that this bomb is legally diffused, I do not see evidence that the FDA approved a ‘ different’ drug.