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Posts Tagged ‘Comirnaty’

The FDA has Stockholm Syndrome

Posted by M. C. on January 6, 2022

Employees, the lesson for you here is, first seek an exemption.  If your employer denies your exemption request, then consider asking for the specific brand of vaccination they are demanding.  If they say they don’t care, choose Comiranty and wait because the pandemic charade will be over before Pfizer exposes itself to liability by making Comiranty available.  

https://www.williambernardbutler.com/the-fda-has-stockholm-syndrome/

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Stockholm syndrome is the psychological condition in which a hostage becomes so emotionally and irrationally attached to his or her criminal captor, that the hostage takes the side of the criminal captor as against those trying to thwart the criminal captor.  

It is a sad reflection of the debased state of the U.S. federal government when a $6 billion federal agency actively harms and discredits itself in order to serve the interests of its agency-napper to the detriment of the public it is supposed to serve.  The FDA’s recent actively misleading statements about the FDA-approved status of Pfizer’s Covid shots sadly show that the FDA is playing Patty Hearst to the Pfizer’s SLA.    

The FDA is misleadingly stating that it has approved the Pfizer Covid vaccine, implying that an FDA-approved Pfizer Covid vaccine is currently being offered in the United States.  

The FDA has licensed and approved “a” Pfizer Covid shot.  The distinctive brand-name for the FDA-approved shot is “Comirnaty.”  Do not, however, expect Pfizer to sell, distribute, or make generally available the Comirnaty shot in the U.S.  This is because Pfizer has not obtained legal immunity for the Comirnaty shot.   If Pfizer were to sell, distribute, or make available the Comirnaty shot in the U.S., then Pfizer could be held legally responsible for the adverse health outcomes caused by Comirnaty.  Comirnaty, unlike child vaccines, is subject to normal product liablity laws.  Because of this fact, expect the FDA-approved Comirnaty shot to remain unavailable as long as Pfizer remains exposed to product liability suits brought by anyone injured by Comirnaty shot.  

Pfizer’s other Covid shot, the BioNTech brand shot, enjoys complete legal immunity in the U.S. market but has not obtained FDA approval.  The BioNTech shot is being administered under the Emergency Use Authorization (“EUA”) and enjoys complete legal immunity under the PREP Act.  EUA is a legal end-run around the FDA approval process made possible by the “pandemic.”  

The “show-me-the-incentive-and-I-will-show-you-the-outcome” outcome of the Comirnaty/BioNTech distinction is of course:  (1) Pfizer’s FDA-licensed and approved Comirnaty shot is not available in the United States and won’t be for the foreseeable future; and (2) Pfizer’s unlicensed and unapproved (but legally authorized for emergency use) BioNTech shot is abundantly available and will remain abundantly available.   The reason?  Financial incentives and disincentives.   If Pfizer were to sell or distribute Comirnaty in the U.S., Pfizer would face product liability lawsuits.  Pfizer would be held responsible for the injuries Comirnaty has caused.   Legal responsiblity and liability for injury = powerful economic disincentive to supply = lack of supply.  

Pfizer’s BioNTech shots, however, enjoy complete and total immunity from any and all death, damages and other injuries that they cause.   BioNTech’s immunity means that Pfizer has no risk and no downside for selling it in the U.S.   No legal responsiblity and no liability for injury and death = powerful economic incentive to sell and supply = abundant supply.  

For a loaf of bread a man will transgress.  Pr. 28:21.  

An honest regulator, after going through an arduous expedited approval process, would likely be indignant that its regulatory subject was withholding from the public, in the middle of a “pandemic” mind you, the only licensed and approved anti-pandemic drug.  Not so the FDA.  It falsely implies that the Pfizer vaccine being sold and distributed in the U.S. is FDA approved when it isn’t.  The FDA claims that the two Pfizer shots are the same, although “legally distinct.”  Yes, legally distinct.  If you are killed by the abundantly available BioNTech shot you will have no legal recourse against Pfizer.  If Comirnaty were available and it killed you, you could sue Pfizer and win because Pfizer has determined a known “death rate” for all of its “vaccines.”  In both cases you are dead.  Pfizer has removed the option that allows your family to get compensated for Pfizer’s killing you by removing Comiranty from the market.  The round-heeled FDA will not tell you this.  

Employees, the lesson for you here is, first seek an exemption.  If your employer denies your exemption request, then consider asking for the specific brand of vaccination they are demanding.  If they say they don’t care, choose Comiranty and wait because the pandemic charade will be over before Pfizer exposes itself to liability by making Comiranty available.  If your employer chooses one of the other EUA shots, then remind your employer of his/her Nuremberg Code obligations to provide informed consent before requiring that you submit to an experimental drug test.  If that doesn’t work, you will have to resign.  

Employers, the lesson for you is–grant each and every exemption request, no questions asked.  You are being played.  

Thanks to RFK Jr.’s website for pointing out the Comirnaty/BioNTech distinction.  

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Federal Judge Rejects DOD Claim That Pfizer EUA and Comirnaty Vaccines Are ‘Interchangeable’ – LewRockwell LewRockwell.com

Posted by M. C. on December 3, 2021

A federal district court judge rejected a claim by the U.S. Department of Defense that the Pfizer-BioNTech COVID-19 vaccine being administered under Emergency Use Authorization is interchangeable with Pfizer’s fully licensed Comirnaty vaccine.

That means no Comirnaty lawsuit protection.

https://www.lewrockwell.com/2021/12/no_author/federal-judge-rejects-dod-claim-that-pfizer-eua-and-comirnaty-vaccines-are-interchangeable/

By Michael Nevradakis, Ph.D.
Children’s Health Defense

A federal district court judge has rejected a claim by the U.S. Department of Defense (DOD) that the Pfizer-BioNTech COVID-19 vaccine being administered under Emergency Use Authorization is interchangeable with Pfizer’s Comirnaty vaccine, which in August was fully licensed by the U.S. Food and Drug Administration (FDA).

In an order issued Nov. 12 in Doe et al. v. Austin, U.S. Federal District Judge Allen Winsor of the U.S. District Court for the Northern District of Florida denied a preliminary injunction requested by 16 service members against the U.S. Military’s COVID vaccine mandate. A hearing is scheduled for Sept. 14, 2022.

However, the judge’s acknowledgment that “the DOD cannot mandate vaccines that only have an EUA” is significant for two reasons.

One reason pertains to the difference in ingredients and manufacturing process between Pfizer’s EUA vaccine and the approved Comirnaty vaccine, and the other pertains to the legal difference between a fully licensed vaccine and an EUA vaccine.

The latter reason would apply not just to the Pfizer-BioNTech vaccine, but also to the vaccines produced by Moderna and Johnson & Johnson (Janssen), both of which are authorized only as EUA products.

Under law, everyone has ‘right to refuse’ EUA product

When the FDA approved Pfizer’s Comirnaty COVID-19 vaccine in August, approval was accompanied by a series of confusing documents and equally confusing public statements.

One such confounding statement reads as follows:

“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.”

The FDA provided no explanation as to how the licensed Comirnaty vaccine and the Pfizer-BioNTech EUA vaccine could “be used interchangeably” despite having “certain differences” that make them “legally distinct.”

See the rest here

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2 Things Mainstream Media Didn’t Tell You About FDA’s Approval of Pfizer Vaccine • Children’s Health Defense

Posted by M. C. on August 26, 2021

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.

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.

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

By  Robert F. Kennedy, Jr. Meryl Nass, M.D.

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.

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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.

They know they can’t win this argument on the science and that’s why they had to abolish the public process and independent oversight.

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— Robert F. Kennedy Jr (@RobertKennedyJr) August 23, 2021

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.

Robert F. Kennedy, Jr.'s avatar

Robert F. Kennedy, Jr.

Robert F. Kennedy, Jr.’s reputation as a resolute defender of the environment stems from a litany of successful legal actions.

Meryl Nass, M.D.'s avatar

Meryl Nass, M.D.

Meryl Nass, MD, ABIM, is an internist with special interests in vaccine-induced illnesses, chronic fatigue syndrome, Gulf War illness, fibromyalgia and toxicology.

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