(The Defender) 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 — “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.
