FDA Deviated From Normal Process In Pfizer Vaccine Approval, Documents Show

U.S. drug regulators admitted that they had diverged from the normal vaccine approval process when dealing on Pfizer’s COVID-19 shot, according to newly disclosed documents.

Weeks after Pfizer BioNTech, the partner, announced they had begun a rolling submission Approval of documents COVID-19 vaccineA U.S. Food And Drug Administration Official penned a memorandum authorizing release of a Biologics License Application (BLA) number for the shot, even though regulators considered whether to approve it. one of the documents shows.

“This deviation from our normal practice is done to facilitate product labeling and distribution and is consistent with other Center practices to facilitate vaccine delivery during the declared Public Health Emergency,” Christopher JoneckisThe FDA’s associate director for review management, wrote in the June 17, 2021, memo. “When providing the license number, we should communicate that this license number does not constitute any determination by FDA on the application.”

Joneckis The FDA’s grant of approval was partly responsible for the decision. Emergency Use Authorization (EUA), for the shot in late 2020. That FDA means the FDA “is familiar with and has reviewed much of the information provided in the BLA application,” He said that the majority of this data consisted of data used in an emergency clearance application.

EUAs can be granted if a public health emergency has been declared and the FDA determines it’s “reasonable to believe” The vaccine or other product in question must be approved “may be effective” in diagnosing, treating, and preventing the disease or condition caused or threatened by the public health threat. BLAs require higher evidence levels to show that a product meets the requirements. “safe, pure, and potent.”

A separate document, made public this week, showed that the license number was received. Pfizer Even though there was no approval decision, Pfizer It was requested.

“The Applicant requested a U.S. License Number for BioNTech Manufacturing GmbH with agreement that they will not use it until after the BLA is approved,” the documentA summary of the contents of this article. June 29, 2021, FDA meeting discussing Pfizer’s application, stated.

The It should be noted in summary that Joneckis The memo authorizing release of the number was written “in advance of the typical notification in the approval letter.” After FDA has also stated that it is a public health agency. “generated the license number which will be provided to the Applicant, after filing, in an email message.”

The FDA granted a BLA Pfizer’s vaccine for individuals 16 and older on Aug. 23, 2021. The Later, vaccine was approved for children as young at six months. The FDA has also approved multiple boosters because the vaccine is not performing well against newer variants.

The The release of documents was made possible by Informed Consent Action Network (ICAN) convinced a court in favor of requiring the FDA to produce documents relating to its actions regarding the COVID-19 vaccinations. This was after the FDA claimed it would take years to produce these documents. The In response to the suit, government has provided ICAN documents to the government Freedom Of Information Act requests.

Aaron SiriA lawyer representing the network told a reporter The Epoch Times in an email that the updated documents are “another piece of evidence that supports that licensure of this product quickly became a foregone conclusion.”

The FDA did not respond to a request to comment.

Advisory Committee Meeting ‘Not Needed’

The FDA held only one meeting with its advisory board, the Vaccines And Related Biological Products Advisory Committee (VRBPAC), After Pfizer BioNTech filed their BLA request. That Meeting was about whether to clear vaccines for younger people, and not the new application.

During Multiple panelists were confused about when they would be consulted regarding any BLA requests at the meeting.

“Where are we at with the licensure for adults?” Dr. Archana ChatterjeeOne of them said,

“I’m still unclear when we’re going to be reviewing the BLAs for [adults],” Additional Dr. Steven Pergram, another.

An Official from the FDA revealed in the June 2021: The agency had decided not to consult outside advisers before holding an internal meeting. Pfizer’s application.

Marion Gruber, director Of the FDA’s Office of Vaccines Research & Review, “confirmed that, unless a significant new safety concern or other important issue is discovered during the review of the submission that would necessitate convening the VRBPAC, an Advisory Committee Meeting will not be needed for this BLA,” According to the summary.

The FDA, which has never turned down an EUA/BLA request Moderna Or Pfizer related to their COVID-19 shots, and the U.S. Centers For Disease Control And Prevention, followed a trend of ignoring the advisory boards during the pandemic, which included when they approved and recommended boosters in fall 2022 without any clinical data.

In Another portion of the document states that FDA officials claimed they had already consulted advisory committee five more times between 2002 and 2005. This justifies the decision not to call a meeting. October 2020 June 2021 “to discuss the development, Emergency Use Authorization and licensure of COVID-19 vaccines.”

Zachary Stieber Is a senior reporter The Epoch Times Based in Maryland. He Reports on U.S. and international news.