What The MSM Didn’t Tell You About FDA’s Pfizer Vaccine Approval
Buried in the fine print of Monday’s approval by the U.S. Food and Drug Administration of the Pfizer Comirnaty COVID vaccine are two critical facts that affect whether the vaccine can be mandated, and whether Pfizer can be held liable for injuries.
On Monday, the U.S. Food and Drug Administration (FDA) approved a biologics license application for the Pfizer Comirnaty vaccine.
The press reported that vaccine mandates are now legal for military, healthcare workers, college students and employees in many industries. New York City Mayor Bill de Blasio has now required the vaccine for all teachers and school staff. The Pentagon is proceeding with its mandate for all military service members.
But there are several bizarre aspects to the FDA approval that will prove confusing to those not familiar with the pervasiveness of the FDA’s regulatory capture, or the depths of the agency’s cynicism.
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.
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 products are experimental under U.S. law. Both the Nuremberg Code and federal regulations provide that no one can force a human being to participate in this experiment. Under 21 U.S. Code Sec.360bbb-3(e)(1)(A)(ii)(III), “authorization for medical products for use in emergencies,” it is unlawful to deny someone a job or an education because they refuse to be an experimental subject. Instead, potential recipients have an absolute right to refuse EUA vaccines.
U.S. laws, however, permit employers and schools to require students and workers to take licensed vaccines.
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.
The government has created an extremely stingy compensation program, the Countermeasures Injury Compensation Program, to redress injuries from all EUA products. The program’s parsimonious administrators have compensated under 4% of petitioners to date — and not a single COVID vaccine injury — despite the fact that physicians, families and injured vaccine recipients have reported more than 600,000 COVID vaccine injuries.
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.
When the Centers for Disease Control and Prevention’s (CDC) Advisory Committee for Immunization Practices places a vaccine on the mandatory schedule, a childhood vaccine benefits from a generous retinue of liability protections.
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.
Americans, told that the Pfizer COVID vaccine is now licensed, will understandably assume COVID vaccine mandates are lawful. But only EUA-authorized vaccines, for which no one has any real liability, will be available during the next few weeks when many school mandate deadlines occur.
The FDA appears to be purposefully tricking American citizens into giving up their right to refuse an experimental product.
While the media has trumpeted that the FDA has approved COVID vaccines, the FDA has not approved the Pfizer BioNTech vaccines, nor any COVID vaccines for the 12- to 15-year age group, nor any booster doses for anyone.
And the FDA has not licensed any Moderna vaccine, nor any vaccine from Johnson & Johnson — so the vast majority, if not all, of vaccines available in the U.S. remain unlicensed EUA products.
Here’s what you need to know when somebody orders you to get the vaccine: Ask to see the vial. If it says “Comirnaty,” it’s a licensed product.
If it says “Pfizer-BioNTech,” it’s an experimental product, and under 21 U.S. Code 360bbb, you have the right to refuse.
If it comes from Moderna or Johnson & Johnson (marketed as Janssen), you have the right to refuse.
The FDA is playing bait and switch with the American public — but we don’t have to play along. If it doesn’t say Comirnaty, you have not been offered an approved vaccine.
See more here: childrenshealthdefense.org
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zerohunter
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It sure seems that they have already figured out a liability shield by having the newly approved Cominaty vax also get EUA, at least thats how I understand it…
https://www.lewrockwell.com/2021/08/jon-rappoport/did-fda-really-approve-the-pfizer-covid-vaccine-wait-what/
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Tom
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Anytime you mention the FDA, you really mean big pharma. There is no FDA as being a seperate and independent agency. As with 99% of the fake pandemic and fake vaccines, every statistic, assessment and dictate is nothing more than a comedy of errors, lies and fraud. The only common denominator is that millions of deceived people are suffering and dying while pharma laughs all the way to the bank.
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Saeed Qureshi
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https://bioanalyticx.com/do-fda-and-usp-lie-of-course-all-the-time-2/
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Ken Hughes
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“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.”
According to my (limited) research, these are one and the same thing?
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nobody
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Could the idiot BOT that keeps posting multiple times to posts on here please be blocked or removed, it is getting very tedious .
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Herb Rose
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Hi Nobody,
With hat comment you should change your name to Everybody.
Herb
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MattH
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Tedious. Credibility destroying. Comments of value near instantly disappear into the abys. Some more specialized, qualified, knowledgeable commenters appear to have disappeared altogether. Totalitarian supporting under the delusion of free speech.
I doubt it is a troll paid by the usual suspects but I have been wrong before.
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MattH
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Hi Frank.
The issue of winning the war on climate fraud will be won in the courtroom. Putting together a legal/science template for farming groups and other groups with the wherewithal to fund or defend legal challenge is something the PSI Editors and contributors are in a position to contribute to.
The same is possibly true of big pharma, protection of natural remedies, suppression of scientific knowledge etc.
I am only entitled to an opinion Frank, and as I have previously stated, if you limited your comments to no more than 2 or 3 comments on the list at any one time, as a general rule, without language that may drive away rarely gifted contributors then you would not be destroying the potential of strategic progression. The same is true of flat earthers.
You may have heard of the South African Rugby team. A participant who wants to hog the ball all the time creates a loosing team.
I commented to you about decomposing blood and guts being on a knife blade when that blade cuts some one and watch germ theory in action. Your response. “I have my big boy pants on”. Disingenuous oxygen thief denying rational discussion.
As for worry Frank. I do have a concern about the issues PSI was set up to challenge. There are many who support this site who would like to be a contributor to a winning team.
Those who do not care about being a contributor to a winning team should be entitled to enjoy the information, entertainment and participatory commentary.
Anybody who wishes to destroy the team from within needs to be removed. Essential. Any historian knows this.
The past has shown I am wasting my time attempting to constructively communicate with you but others may read this. Every day is a new beginning.
Matt
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WhoKoo
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Howdy
August 29, 2021 at 11:07 pm | #
37 comments. 36 from the same guy. Is It a record yet?
Something has taken over the asylum.
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