The Biden administration pressured the FDA to ‘change its procedures, cut corners, and lower agency standards,’ to approve Pfizer’s COVID-19 vaccines and authorize boosters, according to a congressional report released earlier this week.
by Brenda Baletti, Ph.D. The Defender
This article was published on The Defender—Children’s Health Defense News & Views Website on June 28, 2024
The Biden administration pressured the U.S. Food and Drug Administration (FDA) to “change its procedures, cut corners, and lower agency standards,” to approve Pfizer’s COVID-19 vaccines and authorize boosters, according to a congressional report released earlier this week.
The approval was key to facilitating the Biden administration’s rollout of the fall 2021 vaccine mandates, despite safety concerns about the shots, according to the report.
“During the pandemic, politics overruled science at the government institutions entrusted with protecting public health,” Rep. Thomas Massie (R-Ky.) said in a press release announcing the report.
“The FDA abandoned its congressional directive to protect citizens from false claims and undisclosed side effects, and instead ignored its own rules to pursue a policy of promoting the vaccine while downplaying potential harms,” he added.
As a result, according to the report, “countless Americans” suffer from vaccine side effects and the FDA has lost credibility with the public.
Following the report’s release a U.S. House of Representatives Judiciary Subcommittee held a hearing Wednesday (June 26)—“Follow the Science?: Oversight of the Biden Covid-19 Administrative State Response”—during which Dr. Philip Krause, former deputy director of the FDA’s Office of Vaccines Research and Review (OVRR) vaccine products provided evidence to support the report’s conclusions.
Krause testified that both he and OVRR Director Marion Gruber were relieved of their responsibilities overseeing the COVID-19 vaccines review process because the administration wanted to rush FDA approval on a faster timeline than their office could deliver and push forward the fall mandates, Vinay Prasad, M.D., MPH, reported.
The approval process was then pushed through by the director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D., and then-Acting FDA Commissioner Janet Woodcock.
Documents obtained by Children’s Health Defense (CHD) through a Freedom of Information Act Request also showed that in early 2021, both Marks and Woodcock were aware of injuries linked to the vaccines.
Krause testified that the original timeline to complete the review process for Pfizer’s Biologics License Application (BLA) for its mRNA COVID-19 product was January 2022, but the team was already shooting to have the process completed earlier.
In early July 2021, “something had happened to completely change the opinion of Drs. Marks and Woodcock regarding the urgency of completing the BLA review,” Krause testified. “It was so important to them that they did not trust the experts who led the Office of Vaccines to do it, even with their help,” he said.
Krause told the committee that on July 19, he and Gruber were taken off the review process and Marks took it over himself.
He added:
“In this meeting, Drs. Woodcock and Marks expressed concern about the rising number of COVID cases in the US and globally, largely caused by the Delta variant and stated their 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 if the product were licensed.”
Marks informed staff that the goal was to complete the review as rapidly as possible, Krause said. Pfizer’s Comirnaty COVID-19 vaccine was licensed on Aug. 23, 2021.
“As predicted by Drs. Woodcock and Marks, vaccine mandates followed immediately afterwards and were announced the same day for DoD [U.S. Department of Defense] and for New York State,” Krause said.
He said that the speed with which the mandates were implemented following authorization, “suggested that the rapid review of the vaccine was motivated more by a desire to mandate vaccines than by other public health considerations.”
Given that mandates are outside of the FDA’s purview, he added, the fact that Marks and Woodcock cited the need for mandates as a reason to speed the review “strongly implies that pressure to complete the review” more rapidly than planned came from outside of the FDA, he added.
When Krause and Gruber tried to implement a slower and more deliberative process, they were demoted, Prasad wrote.
As a result, they both left the agency at the end of 2021.
Prasad noted the mandates were issued only after the administration knew the vaccine couldn’t stop transmission and “as such, the mandates were unethical.”
“Krause’s testimony shows the Biden administration engaged in inappropriate political tampering with the FDA, and the FDA leaders—Woodcock and Marks—folded to political pressure,” he added.
Woodcock, now retired from the FDA, has since expressed regret about not doing more to respond to the concerns of the vaccine-injured, telling The New York Times she is “disappointed” in herself
Marks is still at the FDA, where Prasad said he “has been doing a bad job,” recently authorizing a product from Sarepta Therapeutics despite a failed study and a negative decision from reviewers.
Robert F. Kennedy Jr., independent presidential candidate and CHD’s chairman on leave, tweeted that Marks also made commercials for the vaccine, claiming it was safe and effective in pregnancy and for children. “Had Pfizer said that, it would have been a crime,” Kennedy said.
In his testimony, Krause also made a series of comments confirming early knowledge of myocarditis—with rates as high as 1 in 5,000 for young men in early studies—and the protection conferred by natural immunity.
He also said that he did not take a booster shot.
Chief Nerd called Krause’s comments “stunning admissions” and posted a video clip on X, formerly known as Twitter:
The Defender on occasion posts content related to Children’s Health Defense’s nonprofit mission that features Mr. Kennedy’s views on the issues CHD and The Defender regularly cover. In keeping with Federal Election Commission rules, this content does not represent an endorsement of Mr. Kennedy, who is on leave from CHD and is running as an independent for president of the U.S.
This article was originally published by The Defender—Children Health Defense News & Views Website under Creative Commons license CC BYNC-ND 4.0.0.
