Documents Show: FDA Deviated from Normal Process in Vaccine Approval

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U.S. drug regulators have acknowledge deviations from the normal vaccine approval process when dealing with the Pfizer Covid-19 shot. The newly disclosed documents show this.

“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 Associate director for review management

“When providing the license number, we should communicate that this license number does not constitute any determination by FDA on the application.”-  Christopher Joneckis

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Joneckis says that the decision stemmed in part from the Emergency Use Authorization for the shot in 2020.

In another document, it showed that the license number was given to Pfizer even though no approval decision was made at the time.

“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

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Document reads here

The FDA did not respond to a request for comment by Epoch Times.


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