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FDA Rushed Approval for Pfizer COVID-19 Vaccine to Enable Vaccine Mandates: Emails

U.S. regulators sped up the approval of Pfizer’s COVID-19 vaccine to enable vaccine mandatesAccording to newly released emails.

Pfizer and BioNTech asked The U.S. Food and Drug Administration (FDA) to approve their vaccine in May 2021. Regulators said publicly that the review of the Biologics License Application would likely be done by January 2022, but behind the scenes top agency officials were pushing the Office of Vaccines Research and Review (OVRR) to quickly complete the review.

Dr. Marion Gruber (the head of the office at the moment) and Dr. Phil Krause, their deputy, explained in a memorandum, that the review couldn’t be done before Sept. 15, 2020, according to one the newly released messages.

It was longer than we wanted, however. “OVRR believes that public confidence in COVID-19 vaccines would not be served by rushing our review and evaluation of the submitted data,” Gruber wrote an email to Dr. Janet Woodcock and Dr. Peter Marks. The email contained a summary of the July 19, 2021 meeting between Gruber and Krause, Woodcock, Marks.

Woodcock and Marks met during the meeting. “expressed concern about rising COVID-19 cases … and stated your opinion that, absent a license, states cannot require mandatory vaccination and that people hesitant to get an EUA authorized vaccine would be more inclined to get immunized when the product is licensed,” Gruber.

The vaccines at the time were under emergency use authorization, which generally doesn’t allow mandates. Only certain circumstances allow for the mandate of approved vaccines.

Gruber stated that Krause and Gruber were both concerned by the increasing number of cases. They wanted the Pfizer vaccine to be licensed as soon possible. “However, our concern is that a review that is hyper-accelerated beyond the already very rapid September 15 target date and as a consequence, may be less thorough than our typical review seems more likely to undermine confidence in the vaccine (and, indeed, in FDA’s credibility) than to increase it,” She continued.

Woodcock declined comment.

Marks Gruber, Krause and FDA didn’t respond to requests for comments.

“Previously, one could infer that there was a coupling between regulatory decisions and political expediency. But with these emails, you see the smoking gun,” Dr. Robert Malone, who helped invent the messenger RNA technology that Pfizer’s vaccine uses, told The Epoch Times.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, speaks in Washington on March 18, 2021. (Susan Walsh/Pool/Getty Images)

‘High Level Response’

Woodcock was informed by Marks about the need for an acting commissioner. “a high level response correcting Marion’s September 15 assertion, unless you agree with it (since this will almost certainly be FOIA’ed),” Eventually, released under the Freedom of Information Act.

“Frankly, I am happy to go on the record here to note that though I understand the exhaustion that some are feeling, the lack of urgency and responsiveness to the public health imperative to save lives that seems to be felt by some in leadership of the Office of Vaccines is disappointing to me,” Marks added. “That is my problem, and I will deal with it in due course.”

Gruber was subsequently contacted by Woodcock, who said that the pandemic had been declared. “a once in a lifetime public health crisis.”

“With this public health imperative in mind, as well as the intensifying problem of vaccine hesitancy, we all also agree about the importance of not only reviewing this BLA as efficiently as possible, but also ensuring that it is done thoroughly and in keeping with FDA’s high standards that protect and promote the public health,” Woodcock wrote.

She did not comment on the timeline and said that she had. “not have enough information to venture an opinion” Marks.

“I don’t have much to add to Janet’s response below, except to echo her gratitude for all of your work and to say that I remain absolutely committed to ensuring that we maintain our high quality standards in any work undertaken to further expedite the BLA review,” Marks wrote.

FDA approved the Biologics License Application for Pfizer’s vaccine on Aug. 23, 2021, after bypassing its vaccine advisory panel. The approval was followed by a number of mandates, including one that applies to all U.S. military personnel.

Woodcock stated to FDA workers, after the approval, that they had completed their analysis and reviewed the vaccine. “met our standards of safety and effectiveness, should go a long way to instilling confidence in those who have continued to be reluctant to get vaccinated, and move us a step closer to ending this pandemic.”

The vaccine does not prevent transmission, so it’s unclear how its approval would end the pandemic.

Woodcock stated in a briefing that the application was being reviewed by an agency. “unprecedented timeline” But he claimed that “our efforts to move as quickly as possible have in no way sacrificed scientific standards or the integrity of our process.”

Marks stated that the review of the license application took only 40 percent of the time it takes for such work to be completed.

Gruber and Krause resigned soon after the FDA approved the vaccines.

One month later, FDA approved booster doses as the vaccine had been performing worse against the Delta variant. Based on real-world data and studies, Omicron has provided protection since late 2021. poor Or even negative Protection against infection Data show that there has been an improvement in protection against severe illnesses. sharp drops in the shielding Within months after boosting. The updated boosters will be approved in 2022.

Other email addresses released in 2022Gruber was concerned about companies like Pfizer trying to force the FDA into authorizing boosters. Gruber’s former colleague Dr. Doran Fink sent Fink a missive in which Fink described how Marks had told workers that the FDA would approve boosters. “wouldn’t be doing rushed reviews anymore.”

“I had to bite my tongue … so as not to ask about the booster doses that the administration promised to everyone by Sept. 20!” Fink stated.

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