Exclusive: Biden Admin ‘Ignored’ Covid Vaccine Safety Protocols

The Biden administration pressured federal health agencies to ignore and sidestep several vaccine safety protocols to fast-track its Covid shot mandates, a new report obtained by The Federalist shows.

Published by the House Administrative State Subcommittee, which is spearheaded by Rep. Thomas Massie, R-Ky., the interim staff report reveals how the Biden administration bullied Food and Drug Administration (FDA) officials to “go beyond their legal authorities while … it ignored risks revealed in the initial release of the [Emergency Use Authorization] EUA vaccine and required that the vaccine be given to the military and federal employees.” The administration also mandated large private businesses require their employees to get the shot, but that directive was deemed illegal by the U.S. Supreme Court.

As noted in the report, FDA policy regarding the EUA Covid shots “was that manufacturers and the government monitor and communicate findings as to the effects of a product being rolled out under that lower, emergency-response standard.” In defiance of those protocols, the Biden administration purportedly “pivoted away from this important requirement and sought to ensure the EUA vaccine received full licensure as a way to support vaccine mandates.”

“While the vaccine approval process can be robust and lengthy, the Biden Administration through [then] Acting [FDA] Commissioner Janet Woodcock sought to move on an arbitrary political timeline and pressed the FDA to ignore its regulations in the approval process,” the report reads. “During this time, the Administration ignored or silenced voices that questioned the merits of universal vaccination and downplayed the serious injuries from the EUA vaccine.”

Subcommittee interviews with FDA officials responsible for vaccine approval reportedly unveiled that the agency “rushed the vaccine licensing and subsequent recommendations for vaccine boosters.” Massie and committee members discovered that federal bureaucrats “mishandled reports of vaccine injury, despite requirements to actively obtain, synthesize, and report feedback on the safety and efficacy of the EUA vaccine.”

Documents and interviews from FDA further reveal that the Biden administration aimed to “fully approve” Pfizer’s Covid jab through the Biologics Licensing Application (BLA) process, despite evidence showing the EUA shot could harm patients. According to the report, these decisions are attributed to Woodcock and Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research.

Under Woodcock and Marks, the FDA reportedly “cut corners in its usually rigorous BLA process to brand the Pfizer EUA vaccine as the only fully licensed ‘safe and effective’ COVID-19 vaccine on the market at the time,” the report reads. “The BLA approval occurred despite the objections of the FDA’s experts in vaccine development who were concerned about risks for healthy young people caused by the Pfizer vaccine, particularly the risk of myocarditis.”

The decision to sidestep basic safety protocols when reviewing Pfizer’s shot “comported with pressure to mandate the vaccine,” according to the analysis. When testifying before the subcommittee, Marks attributed his decision to rush the shot’s approval to his desire to, as the report summarized, “appease outsiders who wanted to have an approved vaccine that gave them ‘more confidence’ in a vaccine, even though it was the exact same vaccine already on the market under the EUA.” The FDA official specifically noted how the Biden administration could not mandate the Covid shots unless they received BLA approval from the agency.

As described in the subcommittee’s analysis, the primary factor “standing in the way” of Pfizer’s Covid shot receiving BLA approval “were indications of EUA vaccine injuries in some patients.” Giving said approval for the Pfizer shot by the deadline demanded by the Biden administration would require the FDA to lower its approval standards — a decision Woodcock and Marks reportedly signed off on.

“To ensure a quicker approval, Acting Commissioner Woodcock and Dr. Marks removed the experts who voiced concerns during the BLA process,” the report reads. “Acting Commission Woodcock and Dr. Marks proceeded, despite the concerns, and completed the approval to meet the deadline that the Biden White House had set.”

The subcommittee also cited actions by the CDC to “undermine efforts by members of Congress to clarify the CDC statements about the vaccine’s efficacy” and collude with Big Tech to censor speech questioning the Covid shots’ efficacy. Evidence of this collaboration is documented in a 2022 lawsuit brought against the federal government by Missouri and Louisiana, which alleges that the Biden administration’s collusion with social media companies to silence online speech they don’t like violates the First Amendment.

The U.S. Supreme Court is expected to issue a final verdict on the case (Murthy v. Missouri) in the coming weeks.

“During the pandemic, politics overruled science at the government institutions entrusted with protecting public health,” Massie said in a statement. “Exposing and acknowledging mistakes that were made is a necessary step toward restoring integrity and trust in our regulatory agencies.”

2024-06-24 Politics, Privat… by The Federalist

Shawn Fleetwood is a staff writer for The Federalist and a graduate of the University of Mary Washington. He previously served as a state content writer for Convention of States Action and his work has been featured in numerous outlets, including RealClearPolitics, RealClearHealth, and Conservative Review. Follow him on Twitter @ShawnFleetwood