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

() 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.

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