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.”
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
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.
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.
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.
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.”
Previous case law also appears to provide a precedent against mandating EUA vaccines, especially in the military context.
This prior precedent seems to lend legal credence to the argument that EUA vaccines cannot be mandated, at least for military service members, based on a narrow interpretation of the relevant case law.
Nevertheless, it remains to be seen how courts will ultimately rule in relation to mandating COVID vaccines administered under an EUA
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