Federal Judge rejects Pfizer’s interchangeability and questions the existence of Comirnaty

Debates surrounding Pfizer’s FDA approved Comirnaty vaccine continue as a Federal District Judge recently weighed in on the matter. Judge Allen Winsor of the U.S. District Court for the Northern District of Florida, whom President Donald J. Trump nominated in 2018, rejected the Department of Defenses’ (DOD) claim that Pfizer’s approved Comirnaty vaccine is interchangeable with their Pfizer-BioNTech vaccine, which remains authorized for emergency use (EUA). 

The significance of Judge Winsor’s opinion

In an order issued Nov. 12 in Doe et al. v. Austin, Winsor denied the preliminary injunction requested by more than 15 service members against the Military’s COVID-19 vaccine mandate. Despite denying the request, Winsor’s opinion in the case is significant.

“[T]he DOD cannot mandate vaccines that only have an EUA,” he stated. Although Pfizer’s Comirnaty vaccine received FDA approval in August, the vials in circulation are still labeled for Emergency Use Authorization (EAU). And as the Johnson & Johnson and Moderna vaccines remain under EUA, there is currently no approved COVID-19 vaccine available to the servicemen.

To view the order in its entirety click here.

FDA official unable to prove Comirnaty “exists at all” in court

What’s more, Judge Winsor noted that “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.” 

Considering one of the defendants is Janet Woodcock, the Acting Commissioner of the U.S. Food and Drug Administration, it is striking that the defense was unable to prove the existence of the only FDA approved vaccine in the U.S.

Medically but not legally interchangeable

Winsor also addressed the interchangeability concept that is central to the plaintiffs’ argument. While sites like Reuters and Factcheck.org have covered the science behind how Pfizer’s EAU vaccine is interchangeable with their FDA approved one, Winsor gave a legal opinion on the matter. 

Recounting the plaintiffs’ argument against interchangeability, the judge states, “If the FDA’s goal were to ‘retroactively license’ the EUA vaccine, it had an odd way of doing so—in the same footnote describing the EUA vaccine and Comirnaty as ‘interchangeabl[e],’ the FDA clarifies that the two products are ‘legally distinct.’”

Evaluating this crucial distinction, he explained that “the FDA nowhere claims that EUA vaccine had been licensed as ‘interchangeable’ with Comirnaty.” In that same section of the order, Winsor states that the FDA used the word interchangeable in a practical sense, not a legal one, in its approval documents for the vaccine, and that it was more of a “medical claim, rather than a regulatory claim.”

All of Pfizer’s vaccines, then, that don’t have “Comirnaty” on the label are not FDA approved products. “As a legal matter,” Winsor says, “vaccines sent before August 23—and vaccines produced after August 23 in unapproved facilities—remain ‘product[s] authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act.'”

These statements strengthen the “bait and switch” arguments organizations such as Children’s Health Defense and the Liberty Counsel made upon Comirnaty’s approval. In sum, they claim that the FDA issued approval for a vaccine that’s unavailable to citizens so that the Biden administration could enact vaccine mandates.

In mid-September, the Lynnwood Times also had questions regarding the interchangeability of Pfizer’s EAU vaccine with Comirnaty—bringing attention to the “certain differences” and “legally distinct” portions in the FDA’s approval letter. And although clarifications were issued from the Center for Disease Control and other reputable sources, Winsor’s assertions in court warrant revisiting the subject.

The local search for Comirnaty

While Doe et al. v. Austin is happening in the Northern District of Florida, the Times’ staff surveyed pharmacies across Snohomish County to see if the Comirnaty vaccine is locally available. 

Out of the ten pharmacies contacted from Lynnwood to Monroe, only eight had Pfizer vaccines in stock. But of those eight, none of them had a vial with “Comirnaty” on the label. Most pharmacy techs relayed how they were using the same Pfizer vaccines they’ve had since the beginning.

Though it is a considerably small sample size, it has been about three and a half months since the FDA licensed Pfizer’s Cormirnaty vaccine, and it still appears to be unavailable. (Please contact the Lynnwood Times if you have information regarding Comirnaty vaccines available in Snohomish County).

Chris Beyrer, an epidemiologist at Johns Hopkins Bloomberg School of Public Health, did note that Comirnaty’s arrival might take a while. Back in August, Beyrer explained to the Washington Post that the Pfizer vaccines manufactured before the FDA’s approval cannot legally be branded as Comirnaty even though they’re the same formulation.

“That’s why there may be, for some time, EUA Pfizer doses in use before [fully approved] Comirnaty becomes more widely available,” Beyrer said. “This is standard, nothing unusual, and [it] does not void an EUA.”

EAU products and the option to accept or refuse

If Pfizer’s approved and EAU vaccines are only interchangeable medically but not legally, as Winsor’s opinion indicates, that could impact vaccine mandates across the country. Though debates about whether or not EAU vaccines are considered “experimental” continue—more on that in a moment—American law allows citizens to refuse EUA vaccination and the consequences thereof.

According to United States Code, specifically 21 U.S. Code Sec.360bbb-3(e)(1)(A)(ii)(III) regarding “Authorization for medical products for use in emergencies,” a required condition of an EUA product is “the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.” 

Given this law, whether or not EAU vaccines are considered “experimental” is immaterial when it comes to one’s right to refuse vaccination. Regarding the issue, on one hand, USA Today asserts that the vaccines are not experimental because they still had to undergo testing and approval. And on the other, the Children’s Health Defense claims that “EUA products are considered experimental under U.S. law,” citing the FDA’s website.

Despite the denial of the preliminary injunction, Judge Winsor’s opinion may prove to be instrumental in substantiating arguments against vaccine mandates, which many have taken to courts across the states. As the New York Times reported last month, 11 states sue the Biden administration over its vaccination mandate for large companies.

Concerning the Doe et al. v. Austin case, there will be another hearing in September 2022.