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. is a senior fellow at the National Center for Public Policy Research.
Reprinted with Permission from Heartland Daily News – By Bonner Russell Cohen
The opinions expressed by columnists are their own and do not necessarily represent the views of AMAC or AMAC Action.
Let’s not forget the corners that were cut to get the covid shot developed and approved in the first place. That speeded up process set the stage for the corner cutting that followed.
At least now, we are free to choose whether to get any future covid boosters.
What this country endured at the hands of the progessives during Covid mania was a crime…literally. They lied about everything and they caused an election to be won by their candidate!! They are still doing the lying about the “pandemic” and every other subject they discuss. I am hoping there will be enough GOP voters to get rid of these lying Marxists who hate our country and we, the citizens!
This is a new normal, should not come as a shock. Good news is we all are in the hands of experts.
Who in government has been alighted to China, the designer of the bats and rats studies which murdered millions worldwide, It was to reduce the world population and will continue forever. Colon cancers, severe heart problems, blood clots, of beds in ICU filled with youth dying of many familia diseases they never knew about. Never trust government to mandate health, religion, speech, personal choice, or FREEDOM to you……WE THE PEOPLE! are the GOVERNMENT, not the president,VP, Congress, IRS, CIA, FBI, DOJ, nor MONEY i.e. George Soreos, Zuker-man, or politicals who are “in” for life.
Yet another investigation that will go nowhere and this administration gets away scott free – again.
(However, Trump will be indicted with another charge of felonious jay walking)
Praise for Bonner Russell Cohen for presenting this important information. The public health. establishment needs to get reacquainted with the idea that a code of ethics is in the interest of public health, that ethical standards are not optional — they are requirements in the practice of public health. Epidemiology benefits from truth, from facts. Public trust requires epidemiology that is trustworthy . Let’s have a sense of responsibility in the public health field starting today . Truth is a quality that glows like a bright light in darkness , it does not take policy making procedures that could take long periods of time to enact — Truth is right there like the light in a dark room — just look to it , pick it up , put it where it is needed most . The United States of America needs honorable people in the public health field . There is no substitute for honorable public health personnel . It should be understood by the current public health doctors , researchers, public health law lawyers and others that these lessons from the COVID 19 experience are contributing to policies that will make for needed improvements based on honor ,honesty, integrity .and loyalty to this Nation .that respects truth .
We already knew what they seemingly just exposed. The only thing is they got away with it.
The fact that the Harris/biden administration MANDATED these unproven “vaccines” that didn’t do what “Mr. Science” himself, Fauci, told us themselves would prevent our citizens from getting COVID-19 was just another farce they pulled, should have been more than enough to have lost their positions of power.
Good ole COVID, a MAN-MADE virus that was used and released by the governments of the world, to start putting their populations under the thumb for overall control. The vaccines were not thoroughly tested but those in power knew exactly what they were doing. Note, those who were vaccinated are still having problems while those who did not, are living a good life. Remember, it is the ELITE of this world who wish to control everyone else and reduce the population numbers to their standards even though the world still contains enough resources for billions more.