Federal Judge Rejects DOD Claim That Pfizer EUA and Comirnaty Vaccines Are ‘Interchangeable’

Image: The Defender
Please Share This Story!
When the FDA approved Comirnaty on August 23, +I wrote the next day, FDA/Media Shell Game: Pfizer ‘Vaccine’ Was Not Approved After All and concluded, “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!” Now a federal judge has said exactly the same thing: the Pfizer EUA and Comirnaty shots are NOT “interchangeable”.

The shell game be played by the FDA, Big Pharma, the CDC and medical Technocrats like Antony Fauci, has been an outright lie from day one. All subsequent vax mandates have been based on this lie. Thousands have died or been vaccine injured, jobs have been lost, careers have been shattered and division has ripped America farther apart.

Will this judicial event change anything? Not much. Even after two federal judges separately blocked Biden’s mandate for large employers on constitutional grounds, Biden told his chain of command to ignore them and proceed to demand shots be administered anyway.

Behold, the lawless federal government. The rule of law no longer applies. ⁃ TN Editor

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.

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.”

There are key differences between fully licensed vaccines and those authorized under EUA. EUA products are considered experimental under U.S. law. This means they cannot be mandated, and everyone has the right to refuse such vaccines without consequences.

Τhe Nuremberg Code, as well as federal law, provide that no human being can be forced to participate in a medical 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.

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.”

There are key differences between fully licensed vaccines and those authorized under EUA. EUA products are considered experimental under U.S. law. This means they cannot be mandated, and everyone has the right to refuse such vaccines without consequences.

Τhe Nuremberg Code, as well as federal law, provide that no human being can be forced to participate in a medical 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.

This is also made clear in the FDA fact sheet provided to patients receiving any Pfizer COVID-19 vaccine. It states:

“Under the EUA, it is your choice to receive or not receive the vaccine. Should you decide not to receive it, it will not change your standard medical care.”

However, U.S. law does allow employers and schools to require students and workers to take licensed vaccines.

EUA products can’t be used once fully licensed product becomes available

Another key difference between fully licensed and EUA vaccines is that, under the 2005 Public Readiness and Preparedness Act (PREP Act), EUA vaccines are accompanied by a far-reaching liability shield that protects all parties involved with the product from lawsuits.

Specifically, if one is injured by an EUA vaccine, the only way to claim damages and receive compensation is to apply to the Countermeasures Injury Compensation Program (CICP), an administrative process under the U.S. Department of Health and Human Services (HHS), which authorized the vaccines.

This scheme potentially covers only unpaid medical expenses and lost wages and creates significant barriers for filing a vaccine injury lawsuit.

Notably, under 4% of claims made through this program have been compensated. To date, CICP has not compensated any claims for COVID-19 vaccine injuries.

At this time, the Pfizer Comirnaty vaccine may have no liability shield, making it subject to product liability laws that allow those injured by it to potentially sue for damages, although Pfizer asserts that the vaccine is protected under the PREP Act as well.

When the Centers for Disease Control and Prevention includes a fully licensed vaccine on its recommended vaccination schedule, the vaccines similarly enjoy generous liability protections, but those protections are not as complete as under the PREP Act.

The FDA fact sheet states:

“This EUA for the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed.”

This appears to contradict black-letter law — defined as well-established legal rules that are certain, no longer disputable, free from doubt and generally well-known — in addition to well-established case law.

In this case, an EUA is considered illegal and invalid if there is a fully licensed alternative available. This appears to be the case with Pfizer’s licensed Comirnaty while its EUA Pfizer-BioNTech is still on the market.

As stated by Children’s Health Defense (CHD) in its lawsuit against the FDA and Dr. Janet Woodcock, acting commissioner:

“The black letter law is clear. There can be no biologic license approved to a medical product for diagnosing, preventing or treating COVID-19 if there is also still an Emergency Use Authorization for the same medical product serving the same purpose.”

In another CHD lawsuit, pertaining to mask mandates for school children issued under an EUA, CHD President Mary Holland, co-counsel on the case, stated that “[i]t is black-letter law that EUA devices … cannot be mandated at all.”

Still, many media outlets refer to COVID vaccine mandates as an inevitability, based on a narrative which attempts to (mis)lead the public into believing the COVID vaccines have been fully licensed.

The same media narratives, such as a recent USA Today “fact check,” also claim the Comirnaty and Pfizer-BioNTech vaccines are the same.

CHD though, in its lawsuit against the FDA, argues that Comirnaty’s licensure was a classic “bait and switch,” and that there is no legal basis to retain the EUA status for other COVID vaccines once the FDA has fully licensed a COVID vaccine.

Read full story here…

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.
Subscribe
Notify of
guest
5 Comments
Oldest
Newest Most Voted
Inline Feedbacks
View all comments
elle

Bait and switch for stupid people and the willfully ignorant who want to protect their twisted world view. That’s exactly what the on-going EUA/Comirnaty ‘debate’ is about. We all know that the criminal Biden Administration will continue to deny the killing fields they have in place and will keep them going until they are stopped by the public–law suits or not.

Last edited 1 month ago by elle
elle

Speaking of “killing fields’… You must view this video. It went viral in the EU and has only recently been subtitled for English speakers. It’s the kill shot of information. Please watch it to the end. The doctor reaches the summit of his presentation by making definitive statements that should be heard. He supports the Spanish study but because of his expertise, education and experience in several disciplines such as chemistry he was able to extract the primary cause of those who are dropping dead in front of us.  Dr. Noack was murdered within 24-hrs of this video going viral in Austria/EU. He… Read more »

Greg

Two things. 1. I was led to understand that Cominarty is being used in Europe but not yet produced in the USA, so I’m not sure how they could be used interchangeably. 2. The FDA will only grant a medical product EUA if there is no pre-existing product on the market which is effective against the pathogen. This is why Fauci took such Machiavellian steps to smear HCQ and IVM, which are much more effective against Covid than these failed and dangerous vaccines. Fauci couldn’t admit that such effective products were already in existence or EUA would not have been… Read more »

Anne

I’m starting to believe that covid19 and the alleged mutations are actually weaponized flue variants. No doubt here that tainted vaccines are what got the world into this covid mess. And from the look of things. We can thank vaccine makers and users for more tyranny, suffering and death.

[…] Los Angeles Enforces Vaccine Mandates For Indoor Businesses […]