A spokesperson for the Florida Department of Health (FDOH), responding to an inquiry by The Florida Capital Star related to COVID vaccines, said he was unsure if any of the Food and Drug Agency (FDA) fully approved COVID vaccine –Comirnaty – was being distributed in Florida. The Food and Drug Administration (FDA) approved Comirnaty in August.
The FDOH spokesperson said he was aware of the continued use of the experimental version of the Pfizer vaccine.
Though Pfizer has shipped Comirnaty to the European Union, the vaccine’s availability in the U.S. is unclear.
Also, The Capital Star found that Publix Supermarkets – one of Florida’s largest COVID vaccine distributors – does not identify which Pfizer vaccine is being administered via their network of approximately 325 pharmacies. A review of the Publix website indicates that their pharmacies provide a Pfizer vaccine, but the information on the webpage does not indicate if it is the experimental version or the recently FDA fully approved vaccine. Instead, Publix provides a link to a CDC fact sheet.
The fact sheet informs inquiring patients that they “are being offered either COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2.”
A footnote on the CDC fact sheet notes that “when prepared according to their respective instructions for use, the FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the Emergency Use Authorization (EUA)-authorized Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older can be used interchangeably without presenting any safety or effectiveness concerns.”
Though the CDC indicates the vaccines are “interchangeable,” the FDA concedes that the products are “legally distinct.”
The Capital Star asked the FDA to explain what specific differences there are between Comirnaty and the Pfizer’s EUA vaccine. After a series of inquiries, the FDA explained that the Biologics License Applications (BLAs) – the labeling of Comirnaty and the EUA version of the vaccine – are different.
The agency did not directly address The Capital Star’s inquiry about the specific differences between the full approved Comirnaty and the EUA BioNTech vaccine, or why Pfizer is not shipping Comirnaty if the formulas are “interchangeable.”
The issue related to the two vaccines has impacted military members who are required to take the COVID-19 vaccine based on the premise that it had been fully approved by the FDA.
A recent lawsuit was brought by several military members against the Department of Defense (DOD) in opposition to the vaccine mandate.
In a 32-page ruling handed down on Nov. 12, Federal Judge Allen Winsor of the United States District Court for the District of Northern Florida noted that “Pfizer continues to produce vials of vaccine that are labeled as an EUA drug with packaging material saying, ‘This product has not been approved or licensed by the FDA…’”
“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.”
The DOD contended that for practical purposes, Pfizer’s EUA vaccine and Comirnaty are the same.
“Rather, the DOD argues that once the FDA licensed Comirnaty, all EUA-labeled vials essentially became Comirnaty, even if not so labeled,” the ruling said.
Winsor called that argument “unconvincing.”
Robert Barnes, a high-profile attorney in California and a political commentator told The Ohio Star “it is an illicit bait and switch. There is no FDA fully approved Covid19 vaccine available in the US,” he said. “The unavailable FDA biologic license approved drug is not medically identical & has to abide different manufacturing standards. As important, you have less legal rights and fewer legal remedies when you take an EUA drug than a biologic licensed drug. This directly impacts the legal rights of all Americans.”
The Capital Star will continue to research the use of Comirnaty in Florida.
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Steve Stewart is the Managing Editor and a contributor at The Florida Capital Star. Email tips to [email protected].
