The Department of Defense (DOD) declined to comment on whether it had any of Pfizer’s Food and Drug Administration (FDA) fully approved vaccine called Comirnaty, after one of its lawyers told a federal judge the department had Comirnaty on hand.
“We don’t have anything for you on this,” a DOD spokesman told The Star News Network by email on Wednesday.
Back in November, 16 military members listed as John Doe and Jane Doe filed a lawsuit against the DOD in the Northern District of Florida. They claimed that the DOD’s vaccine mandate was invalid on a number of grounds, including that Comirnaty was not available in the United States.
Pfizer confirmed that fact to The Star last week, a month and a half after the lawsuit was filed. Instead, the company is still shipping its Emergency Use Authorization (EUA) vaccine, which is not FDA approved. The FDA says the products are “legally distinct,” though Pfizer says they are “interchangeable.”
The troops filed anonymously for fear of reprisal and due to its anonymous nature, it was thrown out, but not before some significant statements were made.
“Notably, though, the plaintiffs have shown that the DOD is requiring injections from vials not labeled ‘Comirnaty,'” Judge Allen D. Winsor wrote in his ruling. “Indeed, defense counsel could not even say whether vaccines labeled ‘Comirnaty’ exist at all…. (Although the DOD’s response said it had an adequate Comirnaty supply, it later clarified that it was mandating vaccines from EUA-labeled vials.” [Emphasis added].
The DOD declined to comment multiple times Wednesday regarding whether it has in its possession, or ever had, Comirnaty on hand.
Winsor noted that “the DOD argues that once the FDA licensed Comirnaty, all EUA-labeled vials essentially became Comirnaty, even if not so labeled.” He called that argument “unconvincing.”
Indeed, EUA-labeled vaccine did not become Comirnaty.
The only evidence that Pfizer or the FDA even made that claim was when at least nine EUA-labeled vaccine lots were deemed Biologics License Application (BLA) compliant. BLA compliance is a standard reserved for fully-approved FDA drugs.
Whether those vaccine lots were ever distributed remains unclear. At least one lot ended up at Miami University in Ohio. A nurse there swore an affidavit saying that to the best of her knowledge, that lot was never used.
Pfizer and the FDA did not return comment requests.
– – –
Pete D’Abrosca is a reporter at The Ohio Star and The Star News Network. Follow Pete on Twitter. Email tips to [email protected].
Photo “Vaccine Shots” by New York National Guard. CC BY 2.0.
