Through Ohio attorneys representing Miami University in a lawsuit against the school over its mandatory COVID-19 vaccine policy, The Ohio Star confirmed that at least some batches of Pfizer’s Emergency Use Authorization (EUA) vaccine were deemed Biologics License Application (BLA) compliant.
BLA compliance is typically reserved for Food and Drug Administration (FDA) approved drugs. That is the licensing procedure for drugs seeking to become FDA approved.
But a document from Pfizer requesting FDA approval for its name-brand COVID-19 vaccine called Comirnaty says the following:
Under [Center for Biologic Research]’s request inquiring about what BLA-compliant EUA-labeled lots may be labeled for use upon licensure of COMIRNATY, the Applicant submitted information listing which lots they consider to be manufactured according to the BLA. To address the issue of these lots not bearing the vial label associated with BLA approval, CBER worked with the Applicant to develop a Dear [Healthcare Providers] letter to be included with lots considered BLA-compliant and refers HCP to a website for additional information. CBER requested and the applicant agreed that only EUA-labeled lots that had also undergone CBEP lot release according to the BLA would be considered BLA-compliant and listed at the website included in the Dear HCP letter.
That website is only available for healthcare providers to look up vaccine lot numbers.
But as part of a sworn affidavit in the Miami University lawsuit, a nurse who was in charge of vaccine procurement for the school from Aug. to Nov. told attorneys that one EUA vaccine lot was labeled “BLA-compliant.” That lot was numbered FF2593. (The nurse noted that that vaccine lot was never distributed).
The attorneys also gained access to other EUA vaccine lots labeled as “BLA-compliant.” They are listed here, according to the attorneys.
The distinction is important because it suggests that Pfizer’s “BLA-compliant” EUA vaccines are in some way different from Pfizer’s non-BLA compliant EUA vaccines.
The company has stated numerous times that its EUA vaccine is interchangeable with FDA approved Comirnaty. If some EUA vaccines are different from others, it raises the question of whether the two versions of the vaccine are indeed interchangeable.
Neither the FDA nor Pfizer responded to requests for clarification Wednesday.
Federal Judge Allen Winsor of the Northern District of Florida wrote in a recent ruling 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.”
Several military members sued the DOD on the grounds that they could not obtain FDA approved Comirnaty.
“In short, what people think of as the Pfizer vaccine has two distinct FDA approval statuses,” Winsor wrote. “It is licensed—that is, fully approved—for the two-dose application in those 16 and older. But it is unlicensed and operating under an EUA— that is, an emergency use authorization—for other applications, like for children under 16 and for certain third shots. Nonetheless, the FDA describes the two as the ‘same formulation’ and ‘interchangeabl[e]’ for medical purposes.”
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