On November 12, the US District Court in Florida issued a ruling that despite irregularities in the process, service members suing over the discrepancies in the Department of Defense’s possible use of EUA Pfizer product in lieu of the Biologics License Application (BLA) approved version, Comirnaty, are not entitled to pretrial relief, aka an injunction. The plaintiffs argued that the DoD mandate goes against their statutory right to refuse a EUA vaccine and that recipients of EUA drugs must, by statute, be “informed… of the option to accept or refuse administration of the product” This statutory right to refuse can be waived for military service members only if the President determines in writing that, “complying with the requirement [for EUAs] is not in the interest of national security.” DOD admits that this presidential waiver has not been done in this case. Ergo, DOD cannot at this time mandate a EUA vaccine. Since DOD asserts that only FDA-licensed vaccines are mandated, there is a problem with the plaintiff’s claim: since the claims are facial challenges to the regulations, it is key that on its face the mandate does not require anyone to take a EUA product. Yet, plaintiffs have shown that DOD is mandating injections from vials not labeled “Comirnaty.” DOD attorneys could not even advise the court as to whether vaccines labeled “Comirnaty” exist at all! DoD filed an initial response claiming they had adequate Comirnaty supplies, but later they clarified that it was in fact mandating vaccines from EUA-labeled vials.
DoD Asserts EUA-Labeled Product is BLA-Compliant
DoD asserts that the labeling question is irrelevant as the EUA vials are “chemically identical” to vials labeled “Comirnaty,” while as noted not being certain that the latter even exists at DoD. Per the court, DoD argues that “all EUA-labeled vials essentially become Comirnaty, even if not so labeled.” This argument was found unconvincing: for one, FDA licensure does not retroactively apply to vials shipped prior to the BLA approval. The court found that vaccines sent prior to August 23, as well as vaccines made after that date in a facility not approved by FDA, remain EUA products. Per the applicable statutes, “drugs mandated for military personnel [must] be actually BLA-approved, not merely chemically similar to a BLA-approved drug.” Still, the court found that the plaintiffs “have not shown a likelihood of success….” FDA’s approval of Comirnaty, “explains that certain lots of EUA-labeled vials are nonetheless ‘BLA-compliant,’ and that healthcare providers may disregard the EUA-specific labeling when administering doses from those vials.” DoD asserts that it has a large supply of BLA-compliant product that is EUA-labeled and that it is using these doses.
Plaintiffs Relied on Evidence not in the Record
In a key point, the judge wrote that, “no plaintiff claims he or she was specifically denied a BLA-compliant dose or offered only a dose from a non-BLA-compliant vial. Because the plaintiffs have not shown they are (or will be) required to receive a EUA-labeled, non-BLA compliant vaccine, the plaintiffs have not shown a likelihood of success.” The court goes on to opine further in favor of the defendants: while plaintiffs claimed that FDA failed to follow the law, wrongly determined that EUA and Comirnaty products were interchangeable, and allowed a BLA product to have a EUA label; the court says that they have no legal precedent or authorities and they, “do not dispute that the FDA’s Summary Basis for Regulatory Action specifically included certain EUA-labeled lots under the BLA approval.” Still, FDA’s Comirnaty approval letter states that the drug must be labeled as such. And federal regulation, “could be read to prohibit distributing a fully licensed drug with a EUA-specific label and package insert rather than those its BLA approval requires.” Also key, the court points out that the plaintiffs were relying on evidence and materials that were not formally in the court’s record. Further, the judge said that these plaintiffs have not attempted to use the available administrative remedies to challenge the FDA’s actions.