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

According to recently released documents, the FDA acknowledged deviating from the normal vaccination approval process when dealing with Pfizer’s COVID-19 vaccine approval.

FDA Deviated From Normal Process In Pfizer Vaccine Approval, Documents Show 1

A U.S. Food and Drug Administration official issued a memo allowing the publication of a Biologics License Application (BLA) number for the injection weeks after Pfizer and its partner BioNTech revealed they began a rolling submission of documentation for approval of their COVID-19 vaccine. One of the documents (pdf below) reveals that regulators were still considering whether to approve the BLA.

“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 Joneckis, the 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 claimed that the FDA’s decision to approve the shot’s Emergency Use Authorization (EUA) in late 2020 was a contributing factor. Therefore, he said, the FDA “is familiar with and has reviewed much of the information provided in the BLA application,” which mainly comprised data utilised in the application for emergency approval.

If a public health emergency has been proclaimed and the FDA judges that there is “reasonable cause to believe” that the vaccination or other product “may be effective” in preventing, diagnosing, or treating the disease or condition brought on by the public health hazard, an EUA may be granted. A higher standard of proof is needed to support a BLA, proving that a product is “safe, pure, and potent.”

The licence number was granted to Pfizer despite their having been no clearance decision after Pfizer sought it, according to a different document that was made public this week.

“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 document, a summary of a June 29, 2021, FDA meeting discussing Pfizer’s application, stated.

According to the summary, Joneckis authored the memo approving the disclosure of the number “in advance of the typical notification in the approval letter.” The FDA then “generated the license number which will be provided to the Applicant, after filing, in an email message,” according to a statement.

On August 23, 2021, the FDA approved a BLA for Pfizer’s vaccine for those age 16 and over. Later, the vaccination was authorised for infants as young as six months. As a result of the vaccine’s poor performance against more recent strains, the FDA has also authorised or cleared numerous boosters.

The FDA had first stated that it would take decades to reveal the documents, but the Informed Consent Action Network (ICAN) was able to persuade a court to order the FDA to do so. The documents relate to the FDA’s actions on the COVID-19 vaccines. In response to the lawsuit and requests made under the Freedom of Information Act, the government has been giving ICAN material.

The new documents are “another piece of evidence that supports that licensure of this product quickly became a foregone conclusion,” network lawyer Aaron Siri wrote in an email to The Epoch Times.

Read the document given below:


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