Categories
Biden Pandemic COVID Government Overreach Reprints from others. Vaccines

FDA MUST disclose more COVID-19 vaccine records, US judge rules

FDA MUST disclose more COVID-19 vaccine records, US judge rules

A federal judge has ordered the U.S. Food and Drug Administration to publicly disclose more information underpinning its authorization of COVID-19 vaccines, after failing to persuade the court to end the public records lawsuit.

In a ruling, on Friday, U.S. District Judge Mark Pittman in Fort Worth, Texas, ordered the agency to produce its “emergency use authorization” file to a group of scientists who wanted to see licensing information that the FDA relied on to approve the Pfizer-BioNTech coronavirus vaccine.

“The COVID-19 pandemic is long passed and so has any legitimate reason for concealing from the American people the information relied upon by the government in approving the Pfizer vaccine,” wrote Pittman, appointed in 2019 by then-President Donald Trump.

The lawsuit, filed in late 2021, attracted attention after the FDA said it could take decades to process and disclose records to Public Health and Medical Professionals for Transparency, the group that brought the case.

The FDA declined to comment.

Attorney Aaron Siri, representing the Public Health and Medical Professionals for Transparency, welcomed Pittman’s order.

“The FDA clearly lacks confidence in the review that it conducted to license Pfizer’s COVID-19 vaccine because it is doing everything possible to prevent independent scientists from conducting an independent review,” Siri said.

He said the agency was “hiding from the court and the plaintiff one million pages of clinical trial documents from the COVID-19 vaccine clinical trials.”

The FDA has power to grant “emergency use authorization” for vaccines and some other medical products.

The headquarters of the U.S. Food and Drug Administration (FDA) is seen in Silver Spring, Maryland November 4, 2009.
Representing the Public Health and Medical Professionals for Transparency, attorney Aaron Siri said the FDA was “hiding from the court and the plaintiff one million pages of clinical trial documents from the COVID-19 vaccine clinical trials.” REUTERS

The lawsuit said, “the medical and scientific community and the public have a substantial interest in reviewing the data and information underlying the FDA’s approval of the Pfizer vaccine.”

The agency has countered that its “emergency use authorization” file did not fall within the scientist group’s records request.

The FDA said in a filing that it has produced more than 1 million pages of records in the lawsuit.

The filing also said that it had set up “unprecedented and extraordinary operations” — spending more than $3.5 million — to comply with Pittman’s directives to speed up the search and delivery of responsive records.

Public Health and Medical Professionals for Transparency, whose members include professors and scientists from Yale, Harvard, UCLA and Brown, has posted thousands of records on its website.

The case is Public Health and Medical Professionals for Transparency v. U.S. Food and Drug Administration, U.S. District Court for the Northern District of Texas, No. 4:21-cv-01058-P.

Categories
Biden Biden Cartel Biden Pandemic COVID How sick is this? Leftist Virtue(!) Reprints from others. Tony the Fauch Vaccines

Congess’ FINAL REPORT: COVID Select Concludes 2-Year Investigation, Issues 500+ Page Report+

WASHINGTON – Today [Dec 2, 2024 – TPR], the Select Subcommittee on the Coronavirus Pandemic concluded its two-year investigation into the COVID-19 pandemic and released a final report titled “After Action Review of the COVID-19 Pandemic: The Lessons Learned and a Path Forward.” The final report will serve as a road map for Congress, the Executive Branch, and the private sector to prepare for and respond to future pandemics. Since February 2023, the Select Subcommittee has sent more than 100 investigative letters, conducted more than 30 transcribed interviews and depositions, held 25 hearings and meetings, and reviewed more than one million pages of documents. Members and staff have exposed high-level corruption in America’s public health system, confirmed the most likely origin of the pandemic, held COVID-19 bad actors publicly accountable, fostered bipartisan consensus on consequential pandemic-era issues, and more. This 520-page final report details all findings of the Select Subcommittee’s investigation.

This work will help the United States, and the world, predict the next pandemic, prepare for the next pandemic, protect ourselves from the next pandemic, and hopefully prevent the next pandemic. Members of the 119th Congress should continue and build off this work, there is more information to find and honest actions to be taken,” wrote Chairman Wenstrup in a letter to Congress. “The COVID-19 pandemic highlighted a distrust in leadership. Trust is earned. Accountability, transparency, honesty, and integrity will regain this trust. A future pandemic requires a whole of America response managed by those without personal benefit or bias. We can always do better, and for the sake of future generations of Americans, we must. It can be done.”

On Wednesday, December 4, 2024, at 10:30am, the Select Subcommittee will hold a markup of the final report and officially submit the report to the Congressional record. Ahead of the markup, the Select Subcommittee will also release additional supporting materials and recommendations.

The full, 520-page final report can be found here. A summary of the information can be found below:

The Origins of the Coronavirus Pandemic, Including but Not Limited to the Federal Government’s Funding of Gain-of-Function Research

COVID-19 ORIGIN: COVID-19 most likely emerged from a laboratory in Wuhan, China. The FIVE strongest arguments in favor of the “lab leak” theory include:

  1. The virus possesses a biological characteristic that is not found in nature.
  2. Data shows that all COVID-19 cases stem from a single introduction into humans. This runs contrary to previous pandemics where there were multiple spillover events.
  3. Wuhan is home to China’s foremost SARS research lab, which has a history of conducting gain-of-function research at inadequate biosafety levels.
  4. Wuhan Institute of Virology (WIV) researchers were sick with a COVID-like virus in the fall of 2019, months before COVID-19 was discovered at the wet market.
  5. By nearly all measures of science, if there was evidence of a natural origin it would have already surfaced.

PROXIMAL ORIGIN PUBLICATION: “The Proximal Origin of SARS-CoV-2” publication — which was used repeatedly by public health officials and the media to discredit the lab leak theory — was prompted by Dr. Fauci to push the preferred narrative that COVID-19 originated in nature.

GAIN-OF-FUNCTION RESEARCH: A lab-related incident involving gain-of-function research is most likely the origin of COVID-19. Current government mechanisms for overseeing this dangerous gain-of-function research are incomplete, severely convoluted, and lack global applicability.

ECOHEALTH ALLIANCE INC. (ECOHEALTH): EcoHealth — under the leadership of Dr. Peter Daszak — used U.S. taxpayer dollars to facilitate dangerous gain-of-function research in Wuhan, China. After the Select Subcommittee released evidence of EcoHealth violating the terms of its National Institutes of Health (NIH) grant, the U.S. Department of Health and Human Services (HHS) commenced official debarment proceedings and suspended all funding to EcoHealth.

  • New evidence also shows that the Department of Justice (DOJ) has opened an investigation into EcoHealth’s pandemic-era activities.

NIH FAILURES: NIH’s procedures for funding and overseeing potentially dangerous research are deficient, unreliable, and pose a serious threat to both public health and national security. Further, NIH fostered an environment that promoted evading federal record keeping laws — as seen through the actions of Dr. David Morens and “FOIA Lady” Marge Moore.


The Efficacy, Effectiveness, and Transparency of the Use of Taxpayer Funds and Relief Programs to Address the Coronavirus Pandemic, Including Any Reports of Waste, Fraud, or Abuse

COVID-19 RELIEF FUNDING: Federal and state governments had significant lapses in coordination, were unprepared to oversee the allocation of COVID-19 relief funds, and failed to sufficiently identify waste, fraud, and abuse of taxpayer dollars during the pandemic.

PAYCHECK PROTECTION PROGRAM: The Paycheck Protection Program — which offered essential relief to Americans in the form of loans that could be forgiven if the funds were used to offset pandemic-era hardships — was rife with fraudulent claims resulting in at least $64 billion of taxpayers’ dollars lost to fraudsters and criminals.

FRADULENT UNEMPLOYMENT CLAIMS: Fraudsters cost the American taxpayer more than $191 billion dollars by taking advantage of the federal government’s unemployment system and exploiting individuals’ personally identifiable information.

SMALL BUSINESS ADMINISTRATION (SBA) FAILURES: $200 million of taxpayers’ dollars were lost as a result of the SBA’s inability to conduct proper oversight, implement internal controls, and ensure fraud protection measures were enacted.

TRANSNATIONAL FRAUD: At least half of the taxpayer dollars lost in COVID-19 relief programs were stolen by international fraudsters.

COVID-19 RELIEF FUNDING OVERSIGHT: Expanding relief programs that lacked proper oversight functions exposed severe vulnerabilities in the system and paved the way for fraudsters, international criminals, and foreign adversaries to take advantage of taxpayers.


The Implementation or Effectiveness of Any Federal Law or Regulation Applied, Enacted, or Under Consideration to Address the Coronavirus Pandemic and Prepare for Future Pandemics

WORLD HEALTH ORGANIZATION (WHO): The WHO’s response to the COVID-19 pandemic was an abject failure because it caved to pressure from the Chinese Communist Party and placed China’s political interests ahead of its international duties. Further, the WHO’s newest effort to solve the problems exacerbated by the COVID-19 pandemic — via a “Pandemic Treaty” — may harm the United States.

SOCIAL DISTANCING: The “6 feet apart” social distancing recommendation — which shut down schools and small business across the country — was arbitrary and not based on science. During closed door testimony, Dr. Fauci testified that the guidance, “sort of just appeared.”

MASK MANDATES: There was no conclusive evidence that masks effectively protected Americans from COVID-19. Public health officials flipped-flopped on the efficacy of masks without providing Americans scientific data — causing a massive uptick in public distrust.

LOCKDOWNS: Prolonged lockdowns caused immeasurable harm to not only the American economy, but also to the mental and physical health of Americans, with a particularly negative effect on younger citizens. Rather than prioritizing the protection of the most vulnerable populations, federal and state government policies forced millions of Americans to forgo crucial elements of a healthy and financially sound life.

NEW YORK PANDEMIC FAILURES: Former New York Governor Andrew Cuomo’s March 25 Order — which forced nursing homes to accept COVID-19 positive patients — was medical malpractice. Evidence shows that Mr. Cuomo and his Administration worked to cover up the tragic aftermath of their policy decisions in an apparent effort to shield themselves from accountability.

  • Evidence suggests Mr. Cuomo knowingly and willfully made false statements to the Select Subcommittee on numerous occasions about material aspects of New York’s COVID-19 nursing home disaster and the ensuing cover-up. The Select Subcommittee referred Mr. Cuomo to the DOJ for criminal prosecution.

TRAVEL RESTRICTIONS: President Trump’s rapidly implemented travel restrictions saved lives. During Dr. Fauci’s transcribed interview, he unequivocally agreed with every travel restriction issued by the Trump Administration. This testimony runs counter to the public narrative that the Trump Administration’s travel restrictions were xenophobic.

COVID-19 MISINFORMATION: Public health officials often spread misinformation through conflicting messaging, kneejerk reactions, and a lack of transparency. In the most egregious examples of pervasive misinformation campaigns, off-label drug use and the lab leak theory were unjustly demonized by the federal government.

  • The Biden Administration even employed undemocratic and likely unconstitutional methods — including pressuring social media companies to censor certain COVID-19 content — to fight what it deemed misinformation.

The Development of Vaccines and Treatments, and the Development and Implementation of Vaccination Policies for Federal Employees and Members of the Armed Forces

OPERATION WARP SPEED: President-elect Trump’s Operation Warp Speed — which encouraged the rapid development and authorization of the COVID-19 vaccine — was highly successful and helped save millions of lives.

COVID-19 VACCINE: Contrary to what was promised, the COVID-19 vaccine did not stop the spread or transmission of the virus.

RUSHED COVID-19 VACCINE APPROVAL: The FDA rushed approval of the COVID-19 vaccine in order to meet the Biden Administration’s arbitrary mandate timeline. Two leading FDA scientists warned their colleagues about the dangers of rushing the vaccine approval process and the likelihood of adverse events. They were ignored, and days later, the Biden Administration mandated the vaccine.

VACCINE MANDATES: Vaccine mandates were not supported by science and caused more harm than good. The Biden Administration coerced healthy Americans into compliance with COVID-19 vaccine mandates that trampled individual freedoms, harmed military readiness, and disregarded medical freedom to force a novel vaccine on millions of Americans without sufficient evidence to support their policy decisions.

NATURAL IMMUNITY: Public health officials engaged in a coordinated effort to ignore natural immunity — which is acquired through previous COVID-19 infection — when developing vaccine guidance and mandates.

VACCINE INJURY REPORTING SYSTEM: Vaccine injury reporting systems created confusion, failed to properly inform the American public about vaccine injuries, and deteriorated public trust in vaccine safety during the COVID-19 pandemic.

VACCINE INJURY COMPENSATION: The government is failing to efficiently, fairly, and transparently adjudicate claims for the COVID-19 vaccine injured.


The Economic Impact of the Coronavirus Pandemic and Associated Government Response on Individuals, Communities, Small Businesses, Health Care Providers, States, and Local Government Entities

BUSINESS IMPACTS: Federal and state governments imposed mandatory lockdowns that were the primary cause of temporary and permanent business closures. More than 160,000 businesses closed due to the pandemic — with 60% of those closures classified as permanent. For the businesses that stayed or re-opened, the lack of supply chain diversity exacerbated pandemic-era challenges and deepened existing disparities.

HEALTHCARE IMPACTS: America’s healthcare system was severely damaged by the COVID-19 pandemic. Patients experienced a decreased quality-of-care, longer wait times, shorter medical appointments, and missed diagnoses.

WORKER IMPACTS: Unemployment rates surged to levels not seen since the Great Depression. Overly broad mitigation measures — including the now debunked “6 feet apart” guidance — disproportionately impacted sectors with low wage earners.

FEDERAL RESERVE: The Federal Reserve’s aggressive, early, and unprecedented response to the COVID-19 pandemic prevented a severe economic downturn. This continued approach also contributed to staggering inflation.


The Societal Impact of Decisions to Close Schools, How the Decisions Were Made and Whether There is Evidence of Widespread Learning Loss or Other Negative Effects as a Result of These Decisions

COVID-19 SCHOOL CLOSURES: The “science” never justified prolonged school closures. Children were unlikely to contribute to the spread of COVID-19 or suffer severe illness or mortality. Instead, as a result of school closures, children experienced historic learning loss, higher rates of psychological distress, and decreased physical well-being.

CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) INFLUENCE: The Biden Administration’s CDC broke precedent and provided a political teachers organization with access to its scientific school reopening guidance. Former CDC Director Rochelle Walensky asked the American Federation of Teachers (AFT) to provide specific language for the guidance and even went so far as to accept numerous edits made by AFT.

AFT INFLUENCE: Schools remained closed longer than necessary because of AFT’s political interference in the CDC’s school reopening guidance. AFT is a political union, not a scientific organization, that advocated for mitigation efforts that prolonged school closures — including an automatic closure “trigger.”

  • Testimony revealed that AFT President Weingarten had a direct telephone line to contact former CDC Director Walensky.

LONGTERM IMPACTS: Standardized test scores show that children lost decades worth of academic progress as a result of COVID-19 school closures. Mental and physical health concerns also skyrocketed — with suicide attempts by 12-17 year-aged girls rising 51%.


Cooperation By the Executive Branch and Others with Congress, the Inspectors General, the Government Accountability Office, and Others in Connection with Oversight of the Preparedness for and Response to the Coronavirus Pandemic

HHS OBSTRUCTION: The Biden Administration’s HHS engaged in a multi-year campaign of delay, confusion, and non-responsiveness in an attempt to obstruct the Select Subcommittee’s investigation and hide evidence that could incriminate or embarrass senior public health officials. It appears that HHS even intentionally under-resourced its component that responds to legislative oversight requests.

ECOHEALTH OBSTRUCTION: EcoHealth President Dr. Peter Daszak obstructed the Select Subcommittee’s investigation by providing publicly available information, instructing his staff to reduce the scope and pace of productions, and doctoring documents before releasing them to the public. Further, Dr. Daszak provided false statements to Congress.

DR. DAVID MORENS: Dr. Fauci’s Senior Advisor, Dr. David Morens, deliberately obstructed the Select Subcommittee’s investigation, likely lied to Congress on multiple occasions, unlawfully deleted federal COVID-19 records, and shared nonpublic information about NIH grant processes with EcoHealth President Dr. Peter Daszak.

NEW YORK OBSTRUCTION: New York’s Executive Chamber — led presently by Governor Kathy Hochul — redacted documents, offered numerous illegitimate privilege claims, and withheld thousands of documents without an apparent legal basis to obstruct the Select Subcommittee’s investigation into former Governor Cuomo’s pandemic-era failures.

Categories
China Corruption COVID How sick is this? Reprints from others. Tony the Fauch Vaccines

WE KNEW IT! O’Keefe Media: NIH Chief Confesses COVID Health Initiatives Were Completely Made Up… “I Probably Shouldn’t Be Saying This Out Loud”

VIA Gateway Pundit

O’Keefe Media Group on Monday released its first undercover video in its NIH Tapes series.

In OMG’s first video release, Raja Cholan, Chief of Health Data Standards Branch US National Library of Medicine, said the Covid health initiatives were completely made up.

“I probably shouldn’t be saying this out loud. They might have funded a lab in Wuhan, China and Pfizer and Moderna are getting a bunch of money from all of these vaccine mandates,” Raja Cholan said to the OMG undercover journalist.

“I don’t even know if these vaccines stop you from getting COVID. They don’t,” Raja Cholan said, adding, “We’re all going to learn [about the dangers of the Covid vaccine] when it’s too late.”

Raja Cholan said the ‘six feet of social distancing’ rule “wasn’t based on any real evidence that it did anything – it was completely made up.”

The NIH Chief told OMG that Trump’s victory is “worse for the NIH.”

“It would be better for a Democrat to be in office,” he said.

“We fly under the radar of really being scrutinized…I don’t think I have too much to worry about. That’s not recording, right?” he said to the undercover journalist.

Watch on X:

 

The National Institutes of Health (NIH) earlier this year finally admitted to funding gain-of-function research at the Wuhan Institute of Virology, the ground zero for the COVID-19 pandemic.

This admission directly contradicts previous statements made under oath by Dr. Fauci, the former director of the National Institute of Allergy and Infectious Diseases (NIAID).

 

Fauci has consistently denied these allegations under oath.

In a 2021 Senate hearing, Fauci clashed with Senator Rand Paul over Fauci’s involvement in funding the Wuhan lab’s gain-of-function research that led to COVID-19.

Fauci and others at the NIH received huge kickbacks from Big Pharma from Covid vaccines.

Robert F. Kennedy Jr., Trump’s nominee for Health and Human Services Secretary, recently left Dr. Phil stunned by the amount of kickbacks Dr. Fauci and other high-level deputies at the National Institute for Health received from Moderna and other major pharmaceuticals.

Categories
Commentary COVID Drugs Links from other news sources. Medicine Science Vaccines

How funny is this? RFK JR.

How funny is this? RFK JR. So Kennedy will be in the cabinet looking over all the junk science that was used to panic and kill over a million folks. I bet Collins, and Tony the Fauch are shitting their pants.

Trump has picked Kennedy as his HHS Secretary. Let’s hope whistle blowers come forward and reveal the shenanigans’ that Collins and Tony did while promoting junk science over at the NIH.

Folks over at the FDA, CDC, and the USDA will also be shitting bricks.

Categories
Back Door Power Grab Biden Pandemic Censorship COVID Crime Reprints from others. Tony the Fauch Vaccines

On Camera: Attorney Who Defended FDA in Court Admits Anti-Ivermectin Campaign was a ‘Mistake’ and an ‘Abuse of Authority’

On Camera: Attorney Who Defended FDA in Court Admits Anti-Ivermectin Campaign was a ‘Mistake’ and an ‘Abuse of Authority’

Original article here

A Department of Justice attorney has been caught admitting in an undercover video that the FDA’s campaign against the use of ivermectin for COVID-19 treatment was not only misguided but also an overreach of its authority.

In December 2021, the Food and Drug Administration (FDA) issued a stern warning to Americans: “Never use medications intended for animals on yourself or other people. Animal ivermectin products are very different from those approved for humans. Use of animal ivermectin for the prevention or treatment of COVID-19 in humans is dangerous.”

This statement, which came during the height of the COVID-19 pandemic, was not only controversial but also deeply flawed, as the FDA had previously praised the drug in other contexts.

Ivermectin, a drug that had been safely used in humans since 1966, had been vilified by the FDA during the pandemic, despite its earlier successes in treating various diseases and even being administered to African migrants by the agency itself back in 2015.

Yet, in the face of mounting evidence—105 controlled studies showing a 61% lower risk in early COVID-19 treatment—the FDA clung to its erroneous position, interested in promoting its agenda than in protecting public health.

A group of courageous doctors, refusing to be silenced, filed a federal lawsuit against the U.S. Department of Health and Human Services (HHS) and the FDA, challenging the agencies’ unlawful attempts to block ivermectin’s use in treating COVID-19.

The lawsuit, filed in the U.S. Southern District of Texas in Galveston, asserts that the FDA overstepped its authority and interfered unjustifiably with medical practice.

Among the plaintiffs were Drs. Mary Talley Bowden, Paul E. Marik, and Robert L. Apter, who accused the FDA of launching a campaign of misinformation. The doctors pointed out that while the FDA had approved ivermectin for human use long before the pandemic, the agency suddenly began spreading falsehoods about its safety when COVID-19 struck.

They argued that this shift in narrative was part of a broader strategy to promote unproven vaccines while suppressing effective treatments.

During the court proceedings, the FDA’s lawyers shockingly admitted that the agency’s recommendations against Ivermectin were only advice and were not mandatory when they told people to “stop” taking Ivermectin for COVID-19.

Isaac Belfer, a lawyer representing the FDA, said, “The cited statements were not directives,” said Isaac Belfer, one of the lawyers. “They were not mandatory. They were recommendations. They said what parties should do. They said, for example, why you should not take ivermectin to treat COVID-19. They did not say you may not do it, you must not do it. They did not say it’s prohibited or it’s unlawful. They also did not say that doctors may not prescribe ivermectin.”

“They use informal language, that is true… It’s conversational but not mandatory,” he continued.

The lawsuit resulted in a significant victory for the doctors, with the FDA being forced to remove its social media posts and consumer advisories against the use of ivermectin for COVID-19.

Belfer, caught on undercover camera by Project Veritas, confessed that the FDA’s actions were an overreach.

“So, what the agency has done… [is] unquestionably beyond its authority. Making a recommendation of what drugs to take or not to take, that’s the practice of medicine. And FDA can’t practice medicine,” Belfer told Project Veritas.

“I think going forward they’ll [FDA] probably be a bit more careful. They [the doctors] got an opinion that was good for them. That kind of limited FDA’s authority. It’s not okay to… actually tell people, ‘You should not take this drug,’” he added.

Drs Apter and Bowden told Project Veritas that suppression of ivermectin led to a prolonged pandemic, and potentially millions in excess COVID deaths.

Apter: “It’s not unreasonable to think that there have been a million unnecessary deaths from COVID in the United States because of the public health agency suppression of effective early treatment with repurposed inexpensive medications.”

Bowden: “If more people had access to early treatment in the form of ivermectin, monoclonal antibodies, hydroxychloroquine… we could have nipped the pandemic in the bud.”

Categories
Biden Biden Cartel Commentary Corruption Government Overreach How sick is this? Leftist Virtue(!) Links from other news sources. Vaccines

How crazy is this? Biden Admin Awards $176 Million to Moderna for ‘Pandemic Influenza Vaccine’.

How crazy is this? Biden Admin Awards $176 Million to Moderna for ‘Pandemic Influenza Vaccine’. The Biden administration will pay $176 million to Moderna to create an “mRNA-based pandemic influenza vaccine,” with health officials citing “lessons learned during the COVID-19 pandemic.”

So now we’re paying Moderna to create a vaccine, then we will buy the vaccine that we paid for? Moderna already started to create their own vaccine, so now there’s no incentive for them to spend their own money.

The first human confirmed to have died from the virus was a 59-year-old Mexican man who contracted it in April, but none here in the United states.

 

Categories
Biden Biden Cartel Biden Pandemic Commentary Corruption COVID Lies Links from other news sources. Tony the Fauch Vaccines

Thanks Tony the Fauch.

Thanks Tony the Fauch. Thanks to Fauci and those who supported them, people will continue to die needlessly.

Mask mandates, social distancing, lockdowns and forced vaccines are still fresh in so many peoples minds. And as we found out, most of those mandates were wasted on healthy people.

We now see that people are not trusting the FDA, CDC, WHO, and especially the NIH. Folks are ignoring all vaccines and if we have another Obama-Biden pandemic people will remember.