A report obtained by The Federalist shows that the Biden administration exerted pressure on federal health agencies to bypass several vaccine safety protocols to expedite Covid-19 vaccine mandates.
This interim staff report, published by the House Administrative State Subcommittee led by Rep. Thomas Massie (R-Ky.), claims that the administration pushed FDA officials to exceed their legal authority while disregarding risks identified during the initial Emergency Use Authorization (EUA) of the vaccine. The administration mandated vaccination for military personnel, federal employees, and large private businesses, although the Supreme Court later ruled the latter directive illegal.
The report outlines that FDA policies for EUA Covid vaccines required manufacturers and the government to monitor and communicate findings regarding the product’s effects under emergency response standards. However, the Biden administration allegedly shifted away from these protocols, aiming to fully license the EUA vaccine to support widespread mandates.
The report criticizes the Biden administration, particularly then-Acting FDA Commissioner Janet Woodcock, for pushing the FDA to expedite the vaccine approval process to meet political deadlines, allegedly ignoring regulations and silencing dissenting voices.
Interviews with FDA officials responsible for vaccine approval revealed that the agency hastened the vaccine licensing and booster recommendations. Subcommittee findings indicated that federal officials mishandled reports of vaccine injuries, failing to properly collect, synthesize, and report safety and efficacy data for the EUA vaccine.
Further documents and interviews suggest the administration intended to fully approve Pfizer’s Covid vaccine through the Biologics Licensing Application (BLA) process, despite evidence of potential harm from the EUA vaccine. The decisions to approve the vaccine under these conditions were reportedly influenced by Woodcock and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
The report states that under Woodcock and Marks, the FDA compromised its rigorous BLA process to label the Pfizer EUA vaccine as the only fully licensed “safe and effective” Covid-19 vaccine at that time. This approval occurred despite objections from FDA experts concerned about risks, such as myocarditis in healthy young individuals. Marks testified that the rush to approve the vaccine was driven by a desire to bolster public confidence, acknowledging that the same EUA vaccine could not be mandated without BLA approval.
The subcommittee’s analysis suggests that concerns about vaccine injuries were a major barrier to Pfizer’s BLA approval. To meet the administration’s deadline, the FDA had to lower its approval standards, a decision endorsed by Woodcock and Marks. The report also claims that they removed experts who voiced concerns during the BLA process to expedite approval.
Additionally, the subcommittee criticized the Centers for Disease Control and Prevention (CDC) for undermining Congressional efforts to clarify statements about the vaccine’s efficacy and for collaborating with Big Tech to censor dissenting opinions. This collaboration was highlighted in a 2022 lawsuit by Missouri and Louisiana, accusing the Biden administration of violating the First Amendment by suppressing online speech. The Supreme Court is expected to rule on this case, Murthy v. Missouri, in the coming weeks.
Read the report: here.
