FDA’s Shell Game – Pfizer Jab Not Approved After All

Oct 6, 2021 by

“FDA’s Shell Game – Pfizer Jab Not Approved After All”

By Donna Garner

10.5.21

[COMMENTS FROM DONNA GARNER:  Below are four articles that explain the FDA’s “shell game” to make us believe that they gave full approval to Pfizer for their vaccine, that the jabs have no adverse reactions, and that everyone in the world needs a COVID vaccination.  That is not true, and we have been lied to once again by the public health hierarchy.]  

ARTICLE #1:

8.24.21 – “FDA/Media Shell Game: Pfizer ‘Vaccine’ Was Not Approved After All” — Posted by Patrick Wood – Technocracy News

https://www.technocracy.news/fda-media-shell-game-pfizer-vaccine-not-approved-after-all/

Excerpts from this article:

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

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.

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  [EUA]. To repeat, Pfizer has no approval for any mRNA vaccine.

…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 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.

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ARTICLE #2: 

8.24.21 – “2 Things Mainstream Media Didn’t Tell You About FDA’s Approval of Pfizer Vaccine” – By Robert F. Kennedy, Jr., Meryl Nass, MD –CHD —

https://childrenshealthdefense.org/defender/mainstream-media-fda-approval-pfizer-vaccine/

(1)  First, the FDA acknowledges that while Pfizer has “insufficient stocks” of the newly licensed Comirnaty vaccine available, there is “a significant amount” of the Pfizer-BioNTech COVID vaccine — produced under Emergency Use Authorization (EUA) — still available for use.

The FDA decrees that the Pfizer-BioNTech vaccine under the EUA should remain unlicensed but can be used “interchangeably” (page 2, footnote 8) with the newly licensed Comirnaty product.

(2)  Second, the FDA pointed out that the licensed Pfizer Comirnaty vaccine and the existing, EUA Pfizer vaccine are “legally distinct,” but proclaims that their differences do not “impact safety or effectiveness.”

There is a huge real-world difference between products approved under EUA compared with those the FDA has fully licensed.

EUA-approved COVID vaccines have an extraordinary liability shield under the 2005 Public Readiness and Preparedness Act. Vaccine manufacturers, distributors, providers and government planners are immune from liability. The only way an injured party can sue is if he or she can prove willful misconduct, and if the U.S. government has also brought an enforcement action against the party for willful misconduct. No such lawsuit has ever succeeded.

At least for the moment, the Pfizer Comirnaty vaccine has no liability shield. Vials of the branded product, which say “Comirnaty” on the label, are subject to the same product liability laws as other U.S. products.

But licensed adult vaccines, including the new Comirnaty, do not enjoy any liability shield. Just as with Ford’s exploding Pinto, or Monsanto’s herbicide Roundup, people injured by the Comirnaty vaccine could potentially sue for damages.

And because adults injured by the vaccine will be able to show that the manufacturer knew of the problems with the product, jury awards could be astronomical.

Pfizer is therefore unlikely to allow any American to take a Comirnaty vaccine until it can somehow arrange immunity for this product.

Given this background, the FDA’s acknowledgement in its approval letter that there are insufficient stocks of the licensed Comirnaty, but an abundant supply of the EUA Pfizer BioNTech jab, exposes the “approval” as a cynical scheme to encourage businesses and schools to impose illegal jab mandates.

The FDA’s clear motivation is to enable Pfizer to quickly unload inventories of a vaccine that science and the Vaccine Adverse Events Reporting System have exposed as unreasonably dangerous, and that the Delta variant has rendered obsolete.

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ARTICLE #3: 

9.24.21 – “Affidavit of LTC. Theresa Long, M D. in Support of a Motion for a Preliminary Injunction Order” — By Patrick Byrne – EdViews.org —

  • None of the ordered Emergency Use Covid 19 vaccines can or will provide better immunity than an infection-recovered person;
  • All three of the EUA Covid 19 vaccines (Comirnaty is not available), in the age group and fitness level of my patients, are more risky, harmful and dangerous than having no vaccine at all, whether a person is Covid recovered or facing a Covid 19 infection;
  • That, in accordance with the foregoing, I hereby recommend to the Secretary of Defense that all pilots, crew and flight personnel in the military service who required hospitalization from injection or received any Covid 19 vaccination be grounded similarly for further dispositive assessment.

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ARTICLE #4:

6.21.21 – “15,472 Dead 1.5 Million Injured (50% Serious) Reported in European Union’s Database of Adverse Drug Reactions for COVID-19 Shots” — By Brian Shilhavy – Global Research — https://www.globalresearch.ca/15472-dead-1-5-million-injured-50-serious-reported-european-union-database-adverse-drug-reactions-covid-19-shots/5748346

Excerpt from this article:

Total reactions for the experimental mRNA vaccine Tozinameran (code BNT162b2,Comirnaty) from BioNTech/ Pfizer: 7,420 deaths and 560,256 injuries to 19/06/2021 [6.19.21]

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[10.6.21 — COMMENTS FROM DONNA GARNER:  Just to make sure that the information as posted above is up-to-date, I went to the latest FDA FACT SHEET dated 9.22.21.  I could find no changes from what is published above. Therefore, the statements made about the FDA’s “shell game” on 8.24.21 are still accurate today.]  

LATEST UPDATE – 9.22.21

9.22.21 — VACCINE INFORMATION FACT SHEET FOR RECIPIENTS AND CAREGIVERS ABOUT COMIRNATY (COVID-19 VACCINE, mRNA) AND PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19)

https://www.fda.gov/media/144414/download

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 prevention of COVID-19 in individuals 16 years of age and older.

The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA

The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide:

  • a two-dose primary series in individuals 12 years of age and older… 

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https://www.comirnaty.com/

The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under Emergency Use Authorization (EUA)…

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