The Biden Administration pressured the Food and Drug Administration (FDA) to expedite approval of Pfizer’s COVID-19 vaccine, according to an interim staff report published by a Subcommittee on the House Judiciary.
The FDA apparently failed to follow traditional regulatory standards, the report says. The agency’s approval allowed the Biden Administration to mandate Pfizer’s BioNTech vaccine for over 3.5 million federal employees and approximately 1.3 million active duty troops.
The Biden Administration aimed to “fully approve the Pfizer vaccine through the Biologics Licensing Application (BLA) process,” a House Judiciary Committee statement reads. BLA review generally takes “ten months to a year” – or if it’s a priority – “six to eight months.” Yet, it took less than four months for the FDA to license the vaccine after Pfizer filed its application, according to the report.
The investigation, led by Republican Subcommittee Chairman Thomas Massie of Kentucky, reveals top FDA officials “cut corners” during the BLA process to ensure Pfizer’s Emergency Use Authorization (EUA) vaccine was approved by the Biden Administration’s deadline. (RELATED: Supreme Court Tosses Conflicting Lower Court Rulings On Biden Admin Vaccine Mandate)
The leadership of the approval process was then-Acting FDA Commissioner Dr. Janet Woodcock and Center for Bioethics Evaluation and Research (CBER) Director Dr. Peter Marks.
Dr. Marks testified the Biden Administration “could not mandate any COVID-19 vaccine” unless it received BLA approval, the report states. FDA internal communications and testimony acquired by the Subcommittee demonstrated Woodcock and Marks “were influenced by outside pressures” to fast track the approval process.
FDA BLA approval was essential for mandating the vaccine. “The only plausible conclusion” is that “the FDA licensed the Pfizer vaccine BLA in the way it did to comport to the Biden Administration’s anticipated mandate on August 24, 2021,” the report says. Former FDA scientists Dr. Gruber and Dr. Krause testified that pressure to mandate vaccines contributed to the rushed review process.
Dr. Woodcock and Dr. Marks “removed the experts” who expressed concerns during the vaccine review, the report documents. Ultimately, the FDA moved forward with the BLA approval process to meet Biden’s deadline.
A potential side effect of mRNA vaccines is myocarditis, a form of heart inflammation that disproportionately affects young males.
The Biden Administration established a vaccine mandate in 2021 for all service members. While it was overturned in 2023 by a provision in the National Defense Authorization Act (NDAA), the mandate culminated in thousands of troops being discharged.
The Subcommittee on the Administrative State, Regulatory Reform and Antitrust will hold a hearing Wednesday, Massie announced on Twitter.
In August 2021, when the Pfizer shots received FDA licensure, and just before the booster received EUA, the top two FDA vaccine reviewers with decades of experience announced their departure.
This Wednesday, I will hold a hearing that will uncover what was happening at FDA. pic.twitter.com/Behi4DyFUj
— Thomas Massie (@RepThomasMassie) June 22, 2024
Massie elaborated on what he said was the politicization of the pandemic and that the FDA “downplay[ed] potential harms” of the COVID-19 vaccines, according to the press release.
“Exposing and acknowledging mistakes that were made is a necessary step toward restoring integrity and trust in our regulatory agencies,” Massie concluded.
