COVID-19
FDA Hid COVID Shot Side Effects—Congressional Report
From Heartland Daily News
By Bonner R Cohen
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”
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.”
KIN, JAPAN – APRIL 28: United States Marines queue to receive the Moderna coronavirus vaccine at Camp Hansen on April 28, 2021 in Kin, Japan. A United States military vaccination program aiming to inoculate all service personnel and their families against Covid-19 coronavirus is under way on Japans southernmost island of Okinawa, home to around 30,000 US troops and one of the largest US Marine contingents outside of mainland USA. (Photo by Carl Court/Getty Images)
‘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.”
BRENTWOOD, NEW YORK – APRIL 12: Gov. Andrew Cuomo speaks with students from Suffolk County Community College after getting vaccinated during a press conference on coronavirus (COVID-19) vaccination at Suffolk County Community College on April 12, 2021 in Brentwood, New York. Gov. Andrew Cuomo held a press conference at Suffolk County Community College, a mass vaccination site, announcing that the state will be sending the coronavirus (COVID-19) vaccine to colleges and universities across New York to encourage college students to get vaccinated before heading home for the summer. (Photo by Michael M. Santiago/Getty Images)
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.”
SEATTLE, WA – JUNE 21: A two-year-old wears a bandage after receiving her first dose of the Pfizer Covid-19 vaccination at UW Medical Center – Roosevelt on June 21, 2022 in Seattle, Washington. Covid-19 vaccinations for children younger than 5 began today across the U.S. (Photo by David Ryder/Getty Images)
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. ([email protected]) is a senior fellow at the National Center for Public Policy Research.
COVID-19
New report warns Ottawa’s ‘nudge’ unit erodes democracy and public trust
The Justice Centre for Constitutional Freedoms has released a new report titled Manufacturing consent: Government behavioural engineering of Canadians, authored by veteran journalist and researcher Nigel Hannaford. The report warns that the federal government has embedded behavioural science tactics in its operations in order to shape Canadians’ beliefs, emotions, and behaviours—without transparency, debate, or consent.
The report details how the Impact and Innovation Unit (IIU) in Ottawa is increasingly using sophisticated behavioural psychology, such as “nudge theory,” and other message-testing tools to influence the behaviour of Canadians.
Modelled after the United Kingdom’s Behavioural Insights Team, the IIU was originally presented as an innocuous “innovation hub.” In practice, the report argues, it has become a mechanism for engineering public opinion to support government priorities.
With the arrival of Covid, the report explains, the IIU’s role expanded dramatically. Internal government documents reveal how the IIU worked alongside the Public Health Agency of Canada to test and design a national communications strategy aimed at increasing compliance with federal vaccination and other public health directives.
Among these strategies, the government tested fictitious news reports on thousands of Canadians to see how different emotional triggers would help reduce public anxiety about emerging reports of adverse events following immunization. These tactics were designed to help achieve at least 70 percent vaccination uptake, the target officials associated with reaching “herd immunity.”
IIU techniques included emotional framing—using fear, reassurance, or urgency to influence compliance with policies such as lockdowns, mask mandates, and vaccine requirements. The government also used message manipulation by emphasizing or omitting details to shape how Canadians interpreted adverse events after taking the Covid vaccine to make them appear less serious.
The report further explains that the government adopted its core vaccine message—“safe and effective”—before conclusive clinical or real-world data even existed. The government then continued promoting that message despite early reports of adverse reactions to the injections.
Government reliance on behavioural science tactics—tools designed to steer people’s emotions and decisions without open discussion—ultimately substituted genuine public debate with subtle behavioural conditioning, making these practices undemocratic. Instead of understanding the science first, the government focused primarily on persuading Canadians to accept its narrative. In response to these findings, the Justice Centre is calling for immediate safeguards to protect Canadians from covert psychological manipulation by their own government.
The report urges:
- Parliamentary oversight of all behavioural science uses within federal departments, ensuring elected representatives retain oversight of national policy.
- Public disclosure of all behavioural research conducted with taxpayer funds, creating transparency of government influence on Canadians’ beliefs and decisions.
- Independent ethical review of any behavioural interventions affecting public opinion or individual autonomy, ensuring accountability and informed consent.
Report author Mr. Hannaford said, “No democratic government should run psychological operations on its own citizens without oversight. If behavioural science is being used to influence public attitudes, then elected representatives—not unelected strategists—must set the boundaries.”
COVID-19
Major new studies link COVID shots to kidney disease, respiratory problems
From LifeSiteNews
Receiving four or more COVID shots was associated with 559% higher likelihood of cold in children, a new study found, and another one linked the shots to higher risk of renal dysfunction.
Two major new studies have been published sounding the alarm about the COVID-19 shots potentially carrying risks of not only respiratory diseases but even kidney injury.
The Washington Stand first drew attention to the studies, published in the International Journal of Infectious Diseases (IJID) and International Journal of Medical Science (IJMS), respectively.
The first examined insurance claims and vaccination records for the entire population of South Korea, filtering out cases of infection prior to the start of the outbreak for a pool of more than 39 million people. It reported that the COVID shots correlated with mixed impacts on other respiratory conditions. A “temporary decline followed by a resurgence of URI [upper respiratory infections] and common cold was observed during and after the COVID-19 pandemic,” it concluded. “In the Post-pandemic period (January 2023–September 2024), the risk of URI and common cold increased with higher COVID-19 vaccine doses,” it noted.
Children in particular, who are known to face the lowest risk from COVID itself, had dramatically higher odds of adverse events the more shots they took. Receiving four or more was associated with 559% higher likelihood of cold, 91% higher likelihood of pneumonia, 83% higher likelihood of URI, and 35% higher likelihood of tuberculosis.
The second study examined records of 2.9 million American adults, half of whom received at least one COVID shot and half of whom did not.
“COVID-19 vaccination was associated with a higher risk of subsequent renal dysfunction, including AKI [acute kidney injury] and dialysis treatment,” it found, citing 15,809 cases versus 11,081. “The cumulative incidence of renal dysfunction was significantly higher in vaccinated than in unvaccinated patients […] At the one-year follow-up, the number of deaths among vaccinated individuals was 7,693, while the number of deaths among unvaccinated individuals was 7,364.” Notably, the study did not find a difference in the “type of COVID-19 vaccine administered.”
The researchers note that this is not simply a matter of correlation, but that a causal mechanism for such results has already been indicated.
“Prior studies have indicated that COVID-19 vaccines can damage several tissues,” they explain.
“The main pathophysiological mechanism of COVID-19 vaccine-related complications involve vascular disruption. COVID-19 vaccination can induce inflammation through interleukins and the nod-like receptor family pyrin domain-containing 3, an inflammatory biomarker. In another study, thrombosis episodes were observed in patients who received different COVID-19 vaccines. Additionally, mRNA COVID-19 vaccines have been associated with the development of myocarditis and related complications […] The development of renal dysfunction can be affected by several biochemical factors [26]. In turn, AKI can increase systemic inflammation and impair the vasculature and red blood cell aggregation. Given that the mechanism underlying COVID-19 vaccine-related complications corresponds to the pathophysiology of kidney disease, we hypothesized that COVID-19 vaccination may cause renal dysfunction, which was supported by the results of this study.”
Launched in the final year of President Donald Trump’s first term in response to COVID-19, Operation Warp Speed (OWS) had the COVID shots ready for use in a fraction of the time any previous vaccine had ever been developed and tested. As LifeSiteNews has extensively covered, a body of evidence steadily accumulated over the following years that they failed to prevent transmission and, more importantly, carried severe risks of their own. COVID was a sticking point for many in Trump’s base, yet he doggedly refused to disavow OWS.
Since leaving office, Trump repeatedly promoted the shots as “one of the greatest achievements of mankind.” The negative reception to such comments got him to drop the subject for a while, but in July 2022, he complained that “we did so much in terms of therapeutics and a word that I’m not allowed to mention. But I’m still proud of that word, because we did that in nine months, and it was supposed to take five years to 12 years. Nobody else could have done it. But I’m not mentioning it in front of my people.”
So far, Trump’s second administration has rolled back several recommendations for the shots but not yet pulled them from the market, despite hiring several vocal critics of the COVID establishment and putting the Department of Health & Human Services under the leadership of America’s most prominent anti-vaccine activist, Robert F. Kennedy Jr. Most recently, the administration has settled on leaving the current vaccines optional but not supporting work to develop successors.
In early August, Kennedy announced the government would be “winding down” almost $500 million worth of mRNA vaccine projects and rejecting future exploration of the technology in favor of more conventional vaccines. Last week, HHS revoked emergency use authorizations (EUA) for the COVID shots, which were used to justify the long-since-rescinded mandates and sidestep other procedural hurdles, and in its place issued “marketing authorization” for those who meet a minimum risk threshold for the following mRNA vaccines: Moderna (6+ months), Pfizer (5+), and Novavax (12+).
“These vaccines are available for all patients who choose them after consulting with their doctors,” Kennedy said, making good on his pledge to “end COVID vaccine mandates, keep vaccines available to people who want them, especially the vulnerable, demand placebo-controlled trials from companies,” and “end the emergency.”
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