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).”

Do vaccines labeled ‘Comirnaty’ even exist?

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.”

What comes next?

Despite the federal judge’s opinion in Doe et al. v. Austin, no court has yet issued a final, definitive ruling that an institution may not mandate a COVID EUA product.

Some courts, most notably in Bridges et al. v. Houston Methodist Hospital, have upheld EUA mandates for employees in a case where 116 hospital employees filed a lawsuit disputing their employer’s vaccine mandate on the grounds the vaccines were being administered under an EUA.

This decision was appealed to the U.S. Court of Appeals for the 5th Circuit, and a decision is far from final.

Previous case law also appears to provide a precedent against mandating EUA vaccines, especially in the military context.

The DOD’s anthrax vaccine immunization program (AVIP), established in 1997, sought to mandate a vaccine previously used for cutaneous anthrax, to protect service members against inhalation anthrax. This alternate use was legally considered off-label usage, requiring informed consent from each individual or a presidential waiver of informed consent.

Service members filed a lawsuit in 2003, seeking to halt the AVIP. Later that year, a federal court, in response to the lawsuit, halted AVIP, due to the DOD’s failure to adhere to informed consent requirements.

The FDA, eight days after this decision, expanded the vaccine’s label to include inhalation anthrax. This decision was challenged by service members on procedural grounds, based on the claim that the FDA did not follow its own regulations regarding label amendments.

In October 2004, a federal district court sided with the service members, vacating the FDA’s decision. Subsequently, then-President Bush signed the Project BioShield Act into law, which amended the Public Health Service Act to “provide protections and countermeasures against chemical, radiological or nuclear agents.”

Following this, the FDA, in December 2004, filed for an EUA for the anthrax vaccine, which was issued within weeks. The new EUA encompassed inhalation anthrax. Vaccinations of service members resumed, but only on a voluntary basis.

It was not until December 2005 that the FDA formally approved a label expansion for the anthrax vaccine, and only after this did mandatory vaccinations resume for certain categories of service members.

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.