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COVID-19

FDA Hid COVID Shot Side Effects—Congressional Report

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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. FDAThe 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.

Brownstone Institute

The Deplorable Ethics of a Preemptive Pardon for Fauci

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From the Brownstone Institute

By Alex Washburne 

Anthony “I represent science” Fauci can now stand beside Richard “I am not a crook” Nixon in the history books as someone who received the poison pill of a preemptive pardon.

While Nixon was pardoned for specific charges related to Watergate, the exact crimes for which Fauci was pardoned are not specified. Rather, the pardon specifies:

Baseless and politically motivated investigations wreak havoc on the lives, safety, and financial security of targeted individuals and their families. Even when individuals have done nothing wrong – and in fact have done the right things – and will ultimately be exonerated, the mere fact of being investigated and prosecuted can irreparably damage reputations and finances.

In other words, the dying breath of the Biden administration appears to be pardoning Fauci for crimes he didn’t commit, which would seem to make a pardon null and void. The pardon goes further than simply granting clemency for crimes. Clemency usually alleviates the punishment associated with a crime, but here Biden attempts to alleviate the burden of investigations and prosecutions, the likes of which our justice system uses to uncover crimes.

It’s one thing to pardon someone who has been subjected to a fair trial and convicted, to say they have already paid their dues. Gerald Ford, in his pardon of Richard Nixon, admitted that Nixon had already paid the high cost of resigning from the highest office in the land. Nixon’s resignation came as the final chapter of prolonged investigations into his illegal and unpresidential conduct during Watergate, and those investigations provided us the truth we needed to know that Nixon was a crook and move on content that his ignominious reputation was carve d into stone for all of history.

Fauci, meanwhile, has evaded investigations on matters far more serious than Watergate. In 2017, DARPA organized a grant call – the PREEMPT call – aiming to preempt pathogen spillover from wildlife to people. In 2018 a newly formed collaborative group of scientists from the US, Singapore, and Wuhan wrote a grant – the DEFUSE grant – proposing to modify a bat sarbecovirus in Wuhan in a very unusual way. DARPA did not fund the team because their work was too risky for the Department of Defense, but in 2019 Fauci’s NIAID funded this exact set of scientists who never wrote a paper together prior or since. In late 2019, SARS-CoV-2 emerged in Wuhan with the precise modifications proposed in the DEFUSE grant submitted to PREEMPT.

It’s reasonable to be concerned that this line of research funded by Fauci’s NIAID may have caused the pandemic. In fact, if we’re sharp-penciled and honest with our probabilities, it’s likely beyond reasonable doubt that SARS-CoV-2 emerged as a consequence of research proposed in DEFUSE. What we don’t know, however, is whether the research proceeded with US involvement or not.

Congress used its constitutionally-granted investigation and oversight responsibilities to investigate and oversee NIAID in search of answers. In the process of these investigations, they found endless pages of emails with unjustified redactions, evidence that Fauci’s FOIA lady could “make emails disappear,” Fauci’s right-hand-man David Morens aided the DEFUSE authors as they navigated disciplinary measures at NIH and NIAID, and there were significant concerns that NIAID sought to obstruct investigations and destroy federal records.

Such obstructive actions did not inspire confidence in the innocence of Anthony Fauci or the US scientists he funded in 2019. On the contrary, Fauci testified twice under oath saying NIAID did not fund gain-of-function research of concern in Wuhan…but then we discovered a 2018 progress report of research NIAID funded in Wuhan revealing research they funded had enhanced the transmissibility of a bat SARS-related coronavirus 10,000 times higher than the wild virus. That is, indisputably, gain-of-function research of concern. Fauci thus lied to the American public and perjured himself in his testimony to Congress, and Senator Rand Paul (R-KY) has referred Fauci’s perjury charges to the Department of Justice.

What was NIAID trying to preempt with their obstruction of Congressional investigations? What is Biden trying to preempt with his pardon of Fauci? Why do we not have the 2019 NIAID progress report from the PI’s who submitted DEFUSE to PREEMPT and later received funding from NIAID?

It is deplorable for Biden to preemptively pardon Fauci on his last day in office, with so little known about the research NIAID funded in 2019 and voters so clearly eager to learn more. With Nixon’s preemptive pardon, the truth of his wrongdoing was known and all that was left was punishment. With Fauci’s preemptive pardon, the truth is not yet known, NIAID officials in Fauci’s orbit violated federal records laws in their effort to avoid the truth from being known, and Biden didn’t preemptively pardon Fauci to grant clemency and alleviate punishment, but to stop investigations and prosecutions the likes of which could uncover the truth.

I’m not a Constitutional scholar prepared to argue the legality of this maneuver, but I am an ethical human being, a scientist who contributed another grant to the PREEMPT call, and a scientist who helped uncover some of the evidence consistent with a lab origin and quantify the likelihood of a lab origin from research proposed in the DEFUSE grant. Any ethical human being knows that we need to know what caused the pandemic, and to deprive the citizenry of such information from open investigations of NIAID research in 2019 would be to deprive us of critical information we need to self-govern and elect people who manage scientific risks in ways we see fit. As a scientist, there are critical questions about bioattribution that require testing, and the way to test our hypotheses is to uncover the redacted and withheld documents from Fauci’s NIAID in 2019.

The Biden administration’s dying breath was to pardon Anthony Fauci not for the convictions for crimes he didn’t commit (?) but to avoid investigations that could be a reputational and financial burden for Anthony Fauci. A pardon to preempt an investigation is not a pardon; it is obstruction. The Biden administration’s dying breath is to obstruct our pursuit of truth and reconciliation on the ultimate cause of 1 million Americans’ dying breaths.

To remind everyone what we still need to know, it helps to look through the peephole of what we’ve already found to inspire curiosity about what else we’d find if only the peephole could be widened. Below is one of the precious few emails investigative journalists pursuing FOIAs against NIAID have managed to obtain from the critical period when SARS-CoV-2 is believed to have emerged. The email connects DEFUSE PI’s Peter Daszak (EcoHealth Alliance), Ralph Baric (UNC), Linfa Wang (Duke-NUS), Ben Hu (Wuhan Institute of Virology), Shi ZhengLi (Wuhan Institute of Virology) and others in October 2019. The subject line “NIAID SARS-CoV Call – October 30/31” connects these authors to NIAID.

It is approximately in that time range – October/November 2019 – when SARS-CoV-2 is hypothesized to have entered the human population in Wuhan. When it emerged, SARS-CoV-2 was unique among sarbecoviruses in having a furin cleavage site, as proposed by these authors in their 2019 DEFUSE grant. Of all the places the furin cleavage site could be, the furin cleavage site of SARS-CoV-2 was in the S1/S2 junction of the Spike protein, precisely as proposed by these authors.

In order to insert a furin cleavage site in a SARS-CoV, however, the researchers would’ve needed to build a reverse genetic system, i.e. a DNA copy of the virus. SARS-CoV-2 is unique among coronaviruses in having exactly the fingerprint we would expect from reverse genetic systems. There is an unusual even spacing in the cutting/pasting sites for the enzymes BsaI and BsmBI and an anomalous hot-spot of silent mutations in precisely these sites, exactly as researchers at the Wuhan Institute of Virology have done for other coronavirus reverse genetic systems. The odds of such an extreme synthetic-looking pattern occurring in nature are, conservatively, about 1 in 50 billion.

The virus did not emerge in Bangkok, Hanoi, Bago, Kunming, Guangdong, or any of the myriad other places with similar animal trade networks and greater contact rates between people and sarbecovirus reservoirs. No. The virus emerged in Wuhan, the exact place and time one would expect from DEFUSE.

With all the evidence pointing the hounds towards NIAID, it is essential for global health security that we further investigate the research NIAID funded in 2019. It is imperative for our constitutional democracy, for our ability to self-govern, that we learn the truth. The only way to learn the truth is to investigate NIAID, the agency Fauci led for 38 years, the agency that funded gain-of-function research of concern, the agency named in the October 2019 call by DEFUSE PI’s, the agency that funded this exact group in 2019.

A preemptive pardon prior to the discovery of truth is a fancy name for obstruction of justice. The Biden administration’s dying breath must be challenged, and we must allow Congress and the incoming administration to investigate the possibility that Anthony Fauci’s NIAID-supported research caused the Covid-19 pandemic.

Republished from the author’s Substack

Author

Alex Washburne is a mathematical biologist and the founder and chief scientist at Selva Analytics. He studies competition in ecological, epidemiological, and economic systems research, with research on covid epidemiology, the economic impacts of pandemic policy, and stock market response to epidemiological news.

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COVID-19

BREAKING: Days before Trump Inauguration HHS fires doctor in charge of gain of function research project

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Dr. Daszak will likely be protected by the DoD & CIA from additional penalties.

By John Leake

HHS Formally Debars EcoHealth Alliance, President Peter Daszak Fired.

On January 17, 2025—just three days before President Trump is to be sworn in—Congress issued a press release with the following statement:

Today, after an eight-month investigation, the U.S. Department of Health and Human Services (HHS) cut off all funding and formally debarred EcoHealth Alliance Inc. (EcoHealth) and its former President, Dr. Peter Daszak, for five years based on evidence uncovered by the Select Subcommittee on the Coronavirus Pandemic.

As far as I can tell, the New York Times did not report this story, though the New York Post did.

More interesting than the superficial news reporting is the HHS ACTION REFERRAL MEMORANDUM  recommending that Dr. Peter Daszak be barred from participating in United States Federal Government procurement and nonprocurement programs.

The Memorandum also states:

Dr. Peter Daszak was the President and Chief Executive Officer of EHA from 2009 until his termination, effective January 6, 2025. Dr. Daszak was the Project Director (PD)/Principal Investigator (PI) for Grant Number 1R01AI110964-01.

I am not sure what to make of this document, which is written in such an arcane and convoluted style that it challenges the attention span of even the most focused reader.

I have been researching this story for four years, and I found the following paragraphs the most intriguing:

9. In a letter dated May 28, 2016, the NIAID contacted EHA concerning possible GoF research based on information submitted in its most recent Year 2 RPPR. The NIAID notified EHA that GoF research conducted under Grant Number 5R01AI110964-03 would be subject to the October 17, 2014, United States Federal Government funding pause, and that per the funding pause announcement, new United States Federal Government funding would not be released for GoF research projects that may be reasonably anticipated to confer attributes to influenza, MERS, or SARS viruses such that the virus would have enhanced pathogenicity and/or transmissibility in mammals via the respiratory route. In the letter, the NIAID requested that EHA provide a determination within 15 days of the date of the letter as to whether EHA’s research under Grant Number 5R01AI110964-03 did or did not include GoF work subject to the funding pause.

10. In a letter dated June 8, 2016, EHA provided a response to the NIAID’s May 28, 2016 letter. EHA explained that the goal of its proposed work was to construct MERS and MERS-like chimeric CoVs in order to understand the potential origins of MERSCoV in bats by studying bat MERS-like CoVs in detail. EHA stated that it believed it was highly unlikely that the proposed work would have any pathogenic potential, but that should any of these recombinants show evidence of enhanced virus growth greater than certain specified benchmarks involving log growth increases, or grow more efficiently in human airway epithelial cells, EHA would immediately: (1) stop all experiments with the mutant, (2) inform the NIAID Program Officer of these results, and (3) participate in decision-making trees to decide appropriate paths forward.

11. Based on the information provided by EHA, the NIAID concluded that the proposed work was not subject to the GoF research pause. In a letter dated July 7, 2016, however, the NIAID informed EHA that should any of the MERS-like or SARS-like chimeras generated under the grant show evidence of enhanced virus growth greater than 1 log over the parental backbone strain, EHA must stop all experiments with these viruses and provide the NIAID Program Officer and Grants Management Specialist, and WIV Institutional Biosafety Committee, with the relevant data and information related to these unanticipated outcomes.

Note that various statements in the above paragraphs are inconsistent with what Baric et al. state in their 2015 paper A SARS-like cluster of circulating bat coronavirus shows potential for human emergence—a research paper funded by the NIAID EcoHealth Grant “Understanding the Risk of Bat Coronavirus Emergence.”

As the authors state in the section on Biosafety and biosecurity:

Reported studies were initiated after the University of North Carolina Institutional Biosafety Committee approved the experimental protocol (Project Title: Generating infectious clones of bat SARS-like CoVs; Lab Safety Plan ID: 20145741; Schedule G ID: 12279). These studies were initiated before the US Government Deliberative Process Research Funding Pause on Selected Gain-of-Function Research Involving Influenza, MERS and SARS Viruses (http://www.phe.gov/s3/dualuse/Documents/gain-of-function.pdf). This paper has been reviewed by the funding agency, the NIH. Continuation of these studies was requested, and this has been approved by the NIH.

As I noted in my series of essays titled The Great SARS-CoV-2 Charade, one of the silliest lies told by Dr. Anthony Fauci has been his insistence that NIAID did not approve Gain-of-Function work by EcoHealth.

Fauci has repeatedly asserted this in a loud and vexed tone, as though he is outraged by the mere proposition. And yet, Ralph Baric and his colleagues—including Zhengli-Li Shi at the Wuhan Institute of Virology—plainly state in their 2015 paper that their Gain-of-Function experiments, performed in Baric’s UNC lab and Zhengli-Li Shi’s lab in Wuhan, were grandfathered in, given that they were funded before the 2014 Pause.

Another statement (in paragraph 11 of the recent HHS Action Referral Memo) that deserves special scrutiny is the following:

In a letter dated July 7, 2016, however, the NIAID informed EHA that should any of the MERS-like or SARS-like chimeras generated under the grant show evidence of enhanced virus growth greater than 1 log over the parental backbone strain, EHA must stop all experiments with these viruses and provide the NIAID Program Officer and Grants Management Specialist, and WIV Institutional Biosafety Committee, with the relevant data and information related to these unanticipated outcomes.

Again, it’s tough to interpret this statement, given that Baric et al. had, by the own admission, already generated chimeras that “replicate efficiently in primary human airway cells and achieve in vitro titers equivalent to epidemic strains of SARS-CoV.”

Let’s review what Baric et al. state in their Abstract about the functionality of the chimeric virus (named SHCOI4-MA15) they claimed to have generated. Using humanized mice (genetically modified to have primary human airway cells) as their experimental animals, the authors state:

Using the SARS-CoV reverse genetics system2we generated and characterized a chimeric virus expressing the spike of bat coronavirus SHC014 in a mouse-adapted SARS-CoV backbone.

The results indicate that group 2b viruses encoding the SHC014 spike in a wild-type backbone can efficiently use multiple orthologs of the SARS receptor human angiotensin converting enzyme II (ACE2), replicate efficiently in primary human airway cells and achieve in vitro titers equivalent to epidemic strains of SARS-CoV. Additionally, in vivo experiments demonstrate replication of the chimeric virus in mouse lung with notable pathogenesis.

To this day, no legal authority that I am aware of has investigated the question: What became of the the chimeras SHC014-MA15 and WIV1-MA15? The latter chimera was documented by Baric et al. in their March 2016 paper titled SARS-like WIV1-CoV poised for human emergencea chimera “that replaced the SARS spike with the WIV1 spike within the mouse-adapted backbone.”

What did the Wuhan Institute of Virology do with these chimeras? Did its researchers continue to modify and experiment with these chimeras?

Another exceedingly silly claim made by U.S. government officials—including members of Congress—is that the true origin of SARS-CoV-2 is likely to remain a mystery, given that the Chinese government and military will almost certainly never agree to perform a full and transparent investigation of their Wuhan Institute of Virology.

What did the U.S. government expect when it agreed to share cutting edge American biotechnology with the Wuhan Institute of Virology, which has long been known to be run by the Chinese military?

One grows weary of our U.S. government officials evading responsibility by pretending to be imbeciles or by revealing themselves to be true imbeciles.

If you found this post informative, please consider becoming a paid subscriber to our Substack. Penetrating the smoke and mirror show performed by the abominable U.S. government requires a great deal of time and effort.

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