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COVID-19

FDA Hid COVID Shot Side Effects—Congressional Report

Published

2 weeks ago

10 minute read

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.

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COVID-19

Andrew Cuomo had aides manipulate death stats to cover up COVID record, report finds

Published on September 15, 2024

By

From LifeSiteNews

By Calvin Freiburger

Republican Brad Wenstrup, chairman of the House subcommittee, explained that ‘the Cuomo Administration is responsible for recklessly exposing New York’s most vulnerable population to COVID-19’

Former New York Democrat Gov. Andrew Cuomo personally edited state COVID-19 statistics to downplay deaths caused by his placement of contagious people in nursing homes, a new congressional investigation found.

For months, New York was the hardest hit of any state by the pandemic, due in large part to the coronavirus spreading within the state’s nursing homes. Cuomo, who resigned in 2021 over sexual harassment claims, ordered that nursing homes cannot turn away patients diagnosed with COVID-19 despite the fact the virus was most dangerous to the elderly.

He initially tried to blame nursing home deaths on the Trump administration by claiming that a federal Centers for Disease Control and Prevention (CDC) guidance forced him to put the infected back in nursing homes (the CDC actually called for elderly housing decisions to be made on a case-by-case basis). But even the office of New York Attorney General (and fellow Democrat) Letitia James found Cuomo’s administration undercounted COVID-19 deaths in nursing homes by as much as half.

A 2021 report by the Judiciary Committee of the New York State Assembly found that Cuomo and his senior aides edited state COVID-19 reports and undercounted nursing home deaths “on multiple occasions” to “strengthen the defense” of his order by excluding COVID deaths that occurred once patients left their nursing home.

On Monday, the U.S. House Select Subcommittee on the Coronavirus Pandemic released a memo confirming those findings, National Review reported.

“The Cuomo Administration is responsible for recklessly exposing New York’s most vulnerable population to COVID-19,” subcommittee chair Brad Wenstrup, a Republican from Ohio, said. “Today’s memo holds Mr. Cuomo and his team accountable for their failures and provides the most detailed and comprehensive accounting of New York’s pandemic-era wrongdoing.”

The committee found that Cuomo assistant Stephanie Benson emailed top aides to get out a “report on the facts” to prevent the governor’s nursing home directive from becoming a “great debacle in the history books. Cuomo has publicly denied involvement in creating the report, his former adviser, Jim Malatras, testified that Cuomo made his desires clear to the authors through his aids and handwritten notes, and even reviewed and edited the document himself multiple times.

Former New York State Department of Health official Dr. Eleanor Adams told investigators that her department did not independently author the report or was it peer reviewed. Others testified that the decision to remove out-of-facility deaths from the count came from the New York Executive Chamber, i.e., the governor’s cabinet.

Cuomo himself testified before the subcommittee this week, where he continued to maintain his innocence. He did, however, admit that he never spoke to anyone at the CDC or Centers for Medicare and Medicaid Services about the scientific justification for his nursing home directive before issuing it.

In May, U.S. Supreme Court Justice Neil Gorsuch penned an opinion identifying America’s COVID response measures as “the greatest intrusions on civil liberties in the peacetime history of this country,” against which Congress, state legislatures, and courts alike were largely negligent to protect constitutional rights, personal liberty, and the rule of law.

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COVID-19

‘Mind-boggling’: Billions gone and little to show for it years after rampant COVID fraud

Published on September 15, 2024

By

From The Center Square

By 

“The estimated amounts of waste, fraud, and abuse in COVID-related programs are simply … mind-boggling,” Subcommittee on Government Operations and the Federal Workforce Chairman Pete Sessions, R-Texas, said at the hearing. “Half a trillion dollars. Maybe more. Much of it lost to criminal actors and our enemies. Often using comically simple tactics.”

Years after the passage of federal COVID-era relief and the subsequent loss of likely hundreds of billions of those taxpayer dollars, lawmakers are still unsure where that money went, how to get it back, and seemingly have done little to prevent it from happening again.

Federal watchdog and other reports estimate anywhere from $200 billion to half a trillion was lost to waste, fraud and abuse across various federal and state COVID-era programs.

“Insiders, including those who worked for state workforce agencies, conspired with organized crime factions and other individuals to defraud state UI programs and the states did little to stop them,” a Republican-led House Oversight Committee report released this week said. “Some states even hired individuals convicted of identity theft to process UI claims.”

Examples like that and the scope of the amount lost was the subject of a House Oversight hearing this week where lawmakers on both sides of the aisle and experts grappled with the scope of the lost funds and what to do about it.

“The estimated amounts of waste, fraud, and abuse in COVID-related programs are simply … mind-boggling,” Subcommittee on Government Operations and the Federal Workforce Chairman Pete Sessions, R-Texas, said at the hearing. “Half a trillion dollars. Maybe more. Much of it lost to criminal actors and our enemies. Often using comically simple tactics.”

The most common among those tactics was stealing unemployment dollars doled out by the federal government during the pandemic.

One inspector general report from the Small Business Adminstration estimated at least $200 billion in taxpayer money was lost.

“We estimate that SBA disbursed over $200 billion in potentially fraudulent COVID-19 EIDLs, EIDL Targeted Advances, Supplemental Targeted Advances, and PPP loans,” the report said. “This means at least 17 percent of all COVID-19 EIDL and PPP funds were disbursed to potentially fraudulent actors.”

Nearly all of those “fraudulent actors” have so far gotten away with the theft.

Congress approved $40 million for the Pandemic Response Accountability Committee, tasked with finding and preventing fraud. That committee and other investigative efforts have shown the COVID-era fraud was rampant and that little has been done to recover those funds.

That committee’s authority expires next year.

“Every dollar that goes to a fraudster doesn’t go to the small business, to the unemployed, to others that Congress were intending to help,” Michael Horowitz, Chair of PRAC, said at the oversight hearing this week. “If we want to continue to advance the fight against improper payments and fraud, we shouldn’t allow this important and fraud fighting tool to expire.”

Horowitz also said at the hearing that there is “clearly insufficient” access to data for oversight, such as accessing Social Security Administration’s death database so that payments are not sent to deceased individuals. He also pushed for his authority to be expanded to helping other agencies.

Orice Williams Brown, chief operating officer at the U.S. Government Accountability Office, also testified at the hearing that federal agencies can do more to prevent fraud of this kind. But federal agencies are not alone in the blame.

The House Oversight report released this week is called the “Widespread Failures and Fraud in Pandemic Unemployment Relief Programs” showing that states mishandled funds doled out by the federal government for unemployment insurance, sometimes with little oversight.

From the report:

The U.S. Government Accountability Office (GAO) estimates 11 to 15 percent of total benefits paid during the pandemic were fraudulent, totaling between $100 to $135 billion. The Department of Labor (DOL) Office of Inspector General (OIG) estimates that at least $191 billion in pandemic UI payments could have been improperly paid, with a significant portion attributable to fraud. As of March 2023, states reported recoveries of improper payments in an amount of only $6.8 billion.

The design of the Pandemic Unemployment Assistance (PUA) program led to massive fraud. During the program’s first nine months, claimants did not have to provide any evidence of earnings or prior work which made the program susceptible to fraud. DOL reported that the PUA program had a total improper payment rate of 35.9 percent.

Both sides have lamented the lost taxpayer dollars, but so far little has been done to prevent it from happening again, even as Congress continues to pass multi-trillion dollar spending bills often with little time for lawmakers to review.

Lawmakers passed two bills in 2023 to increase reporting from federal agencies on fraud and to prevent those previously convicted of financial crimes from receiving certain federal payment.

The House Oversight report recommended stronger security measures, cross checking with other relevant databases, more oversight and transparency, and more documentation from benefit recipients.

“If this is not a call to action…” Sessions said at the hearing. “I simply do not know what is.”

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