A congressional investigation has found evidence the Biden administration pressured drug regulators to cut corners in authorizing COVID-19 shots and boosters.
An interim staff report by the U.S. House Judiciary Committee’s Subcommittee on the Administrative State, Regulatory Reform, and Antitrust concluded the Biden administration “pressured the Food and Drug Administration (FDA) to go beyond its regulatory authority to change its procedures, cut corners, and lower agency standards to approve the Pfizer COVID-19 vaccination and authorize boosters,” states the subcommittee’s press release on the publication of the report, on June 24.
“This approval enabled the Biden administration to mandate the COVID-19 vaccine, despite concerns that the same vaccine was causing injury among otherwise healthy young Americans.”
‘Politics Overruled Science’
“In August 2021, when the Pfizer shots received FDA licensure, and just before the booster received EUA [Emergency Use Authorization], FDA vaccine reviewers with decades of experience announced they were leaving the agency,” said subcommittee Chairman Thomas Massie (R-KY), in a statement. “During the pandemic, politics overruled science at the government institutions entrusted with protecting public health.”
The 29-page report, “Politics, Private Interests, and the Biden Administration’s Deviation from Agency Regulations in the COVID-19 Pandemic,” traces the FDA’s approval process for COVID-19 vaccines and boosters from the last year of the Trump administration, 2020, through the Biden administration’s implementation of its own policies in 2021-22. Development of COVID-19 vaccines began in April 2020 under the Trump administration’s Operation Warp Speed (OWS), which followed the FDA’s standard EUA process.
Emergency Factor
The report says the FDA and manufacturers are supposed to monitor and communicate findings on effects related to a lower standard under an emergency declaration.
“The Biden administration, however, pivoted away from this important requirement and sought to ensure the EUA vaccine received full licensure as a way to support vaccine mandates,” states the report. “While the vaccine approval process can be robust and lengthy, the Biden administration through Acting Commissioner Janet Woodcock sought to move on an arbitrary political timeline and pressed the FDA to ignore its regulations in the approval process.”
“During this time,” the report states, “the administration ignored or silenced voices that questioned the merits of universal vaccination and downplayed the serious injuries from the EUA vaccine.”
Dissent from Within
Subcommittee investigators also examined how the Centers for Disease Control and Prevention (CDC) characterized the efficacy of the vaccine, the FDA’s active promotion of the vaccine in 2021 and 2022, and the CDC’s conduct related to reporting on the safety and efficacy of the vaccine.
“The transcribed interviews and internal FDA documents revealed that, despite evidence of harms from the EUA vaccine, the Biden administration sought to fully approve the Pfizer vaccine through the Biologics Licensing Application (BLA) process,” the report said. “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.”
Peter Marks, M.D., Ph.D., head of the FDA’s Center for Biological Evaluation and Research, testified to the subcommittee that, in rushing approval of the Pfizer vaccine, “he was seeking to 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.”
“Unless changes are made to improve the FDA’s once-robust vaccine approval process,” the report states, “future vaccines approved by the FDA may be met by an American public with increased skepticism and elevate the potential for higher vaccine hesitancy.”
Opened Pandora’s Box
The report’s findings were bolstered by pharmaceutical toxicologist Helmut Sterz, Ph.D., who served for eight years as CEO of global research and development at Pfizer’s lab in Amboise, France. In a July 8 post on Substack by Peter McCullough, M.D., and John Leake, Leake recounted a recent conversation with Sterz.
“Dr. Sterz confirmed that Pfizer-BioNTech did not perform proper toxicology studies on its COVID-19 mRNA ‘vaccine’ prior to its injection into hundreds of millions of people,” wrote Leake. “Those responsible for this undertaking created the Pharma Lab equivalent of a Pandora’s Box that has released a host of sickness and death on mankind.”
Rush to Mandate
Jane Orient, M.D., executive director of the Association of American Physicians and Surgeons, says she is not surprised by the report’s findings.
“The FDA’s regulatory process was clearly short-circuited. Americans have cause to seriously distrust the agency,” said Orient. “Many products, including vaccines, have been pulled from the market because of serious adverse responses, while reports of thousands of adverse effects associated with COVID injections are downplayed or suppressed.”
Orient added, “The people in charge of the rushed approval, such as Janet Woodcock, were also responsible for suppressing early treatment with hydroxychloroquine, as shown in AAPS v. FDA. The FDA failed to note a change in the manufacturing process that introduced DNA contaminants, which remained in impermissible quantities. Long-term effects such as cancer, birth defects, and infertility cannot yet be known.”
Joel Zinberg, M.D., senior fellow at the Competitive Enterprise Institute and director of the Public Health and American Well-Being Initiative at the Paragon Health Institute, also points to the harm resulting from the FDA’s actions.
“The rush to approve the vaccine and mandate its use put otherwise healthy young people who have a virtually non-existent risk of severe COVID-19 illness at risk for little benefit,” said Zinberg. “However, it is in stark contrast to what then-candidates Biden and Harris said in 2020 when they discouraged people from taking ‘Trump’s vaccines.’”
Bonner Russell Cohen, Ph.D. (bcohen@nationalcenter.org) is a senior fellow at the National Center for Public Policy Research.
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