They may well be, if the ruling of a judge in a Florida federal court is allowed to stand. He makes the important point that EUA-authorized (Emergency Use Authorization) vaccines are legally NOT the same as licensed, approved, vaccines. I’m going to quote at length from the report, because if the judge is correct, the way that the US armed forces are treating unvaccinated service personnel at present appears to violate Federal law. Bold, underlined text is my emphasis.
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.”
. . .
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.
A recent lawsuit filed by Arizona’s attorney general against the Biden administration over its vaccine mandates made a similar argument:
“…the whole point of the mandates is to deny any such ‘option’ to those governed by them. Notably, only the Pfizer vaccine has received [U.S. Food and Drug Administration (FDA)] approval, and none of the stock of it in the U.S. is actually the FDA-approved version (and instead is entirely under the EUA label subject to the EUA-mandated conference of choice).”
All of these issues came to the fore in Judge Winsor’s Nov. 12 decision.
As recognized by the judge, “[u]nder the EUA statute, recipients of EUA drugs must be ‘informed … of the option to accept or refuse administration of the product.”
The judge further noted that with regard to the administration of an EUA product to members of the armed forces, such a right of refusal may be waived only by the president.
As noted, “[t]he DOD acknowledges that the president has not executed a [waiver], so as things now stand, the DOD cannot mandate vaccines that only have an EUA.”
Judge Winsor also pointed out that “DOD’s guidance documents explicitly say only FDA-licensed COVID-19 vaccines are mandated.”
While this would be applicable to the Comirnaty vaccine, the judge noted “the plaintiffs have shown that the DOD is requiring injections from vials not labeled ‘Comirnaty.’ Indeed, defense counsel could not even say whether vaccines labeled ‘Comirnaty’ exist at all.”
The judge also noted that the DOD “later clarified that it was mandating vaccines from EUA-labeled vials,” adding that “[i]n the DOD’s view, this is fine because the contents of EUA-labeled vials are chemically identical to the contents of vials labeled ‘Comirnaty’ (if there are any such vials).”
The judge found this argument “unconvincing,” stating that “FDA licensure does not retroactively apply to vials shipped before BLA approval.”
He further noted that EUA provisions suggest “drugs mandated for military personnel be actually BLA-approved, not merely chemically similar to a BLA-approved drug,” not just in terms of labeling, but also in terms of being produced at BLA-compliant facilities.
As the judge stated, “there is no indication that all EUA-labeled vials are from BLA-approved facilities,” adding that “the DOD cannot rely on the FDA to find that the two drugs are legally identical.”
There’s more at the link.
If I’m reading that court order correctly, it means that service personnel who’ve been discriminated against because of their refusal to accept COVID-19 vaccination; who’ve been denied promotions, told their careers were over, forced to give up their status in certain specialities, and so on . . . all of that may be illegal, because none of the vaccines being administered by the Department of Defense are, in fact, FDA-approved. They’re all Emergency Use Authorization vaccines. That means those involved have the legal right to refuse them, and any action taken against them because of that refusal may be actionable under Federal law.
I can only hope that the lawyers for those service personnel get to hear about this ruling, and bring it up in defense of their clients. It may be a game-changer for all of them. If you know any such service personnel, please let them know about this case, and advise them (and their lawyers) to follow up on it. It might make a big difference to their futures.