Tag: fda

COVID mRNA Vaccine Hides Up to 30% of Endotoxin Activity in FDA Test

All FDA-approved and emergency-use-authorized mRNA vaccines use E. coli to produce so-called starting DNA or other manufacturing materials, creating a lipopolysaccharide (LPS) endotoxin contamination risk that manufacturers test for in the finished shots.

Endotoxin has been shown to drive cardiac injury and abnormal clotting in experimental studies, and other outcomes that overlap with myocarditis, blood clots, and other serious events reported after Pfizer’s COVID-19 mRNA vaccine, raising the question of whether endotoxin was adequately excluded as a contributor.

No publicly available information tells us specifically how much endotoxin is present in finished mRNA vaccine vials.

In a January 2022 memo, the FDA reported adding a known amount of endotoxin to three samples of Moderna’s finished COVID vaccine to check whether its test could detect it.

Its test only recovered 80%, 71%, and 70% of the added activity.

Meaning 20%, 29%, and 30% of the control signal went undetected while the added endotoxin was present in the samples.

The endotoxin was still there.

FDA knew how much it had added.

Yet something in the vaccine samples prevented the test from detecting up to 30% of its activity.

FDA nevertheless accepted all three results, raising questions:

  • If the test missed up to 30% of a control added after manufacture, what could it miss when endotoxin enters the vaccine’s lipid particles during manufacture?
  • Why did FDA call the measured loss only “slight inhibition”?
  • And why did the agency allow a complete finished-product release test to wait until after its Spikevax approval decision?
  • Why have regulators and manufacturers not told us exactly how much LPS endotoxin is present in finished mRNA vaccine vials?
  • Why do post-mRNA vaccination adverse events track endotoxin exposure symptoms?

Australian regulator TGA did test Pfizer’s mRNA COVID vaccine batches as “less than 5 EU/mL.”

But that means the assay couldn’t see endotoxin above a prespecified cutoff, and only after it was diluted.

It is not a count of how much total endotoxin is in each vial.

Moreover, studies examined below found that liposomes and other lipid preparations can hide over 90% of incorporated endotoxin from detection, raising the question of what happens in the lipid nanoparticles used in mRNA vaccines.

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FDA Commissioner Nominee Says Every Vaccine On US Market Is Safe, Effective

The doctor nominated by President Trump to lead the Food and Drug Administration (FDA) told senators this week that vaccines available in the United States are safe and effective.

Dr. Heidi Overton, the nominee, said that if confirmed, she could use her scientific training and clinical background to describe to the American public what is currently known about products that fall under Food and Drug Administration oversight.

“And what is currently known is that the vaccines that have been approved by the FDA meet the standards for safety and efficacy,” she said.

Overton, 37, also endorsed the measles, mumps, and rubella vaccine, saying it is not lethal and that it is the best tool in the public health response to measles outbreaks that are ongoing in the United States.

She said that mifepristone, an abortion pill, was safe and effective because it had been approved by the FDA. Overton wrote in a 2023 article that chemical abortion through products such as mifepristone was “dangerous to women,” drawing criticism from Democrats in the Senate.

As Zachary Stieber reports further for The Epoch Times, Overton would take the helm of an agency that has been under acting leadership since Dr. Marty Makary stepped down in May.

While signing an executive order in August that encouraged breaking up the measles combination vaccine, Trump told reporters that the vaccine is possibly “quite lethal” and that separate shots for measles, mumps, and rubella appeared to be “not at all lethal but just very effective.”

When asked after the signing, the White House declined to provide any citations for Trump’s description of the vaccine.

Leaders in the Make America Healthy Again movement recently called for removing vaccines containing messenger ribonucleic acid (mRNA) technology.

Sen. Bill Cassidy (R-La.), an outspoken vaccine proponent, has been asking people whom Trump nominated to serve in high-level health positions about Trump’s comments, as well as other questions about vaccines, during their confirmation hearings before the Senate Health Committee, the panel he chairs. Chris Klomp, selected to be the top deputy to Health Secretary Robert F. Kennedy Jr., recently voiced support for vaccines in response to Cassidy, as did Dr. Nicole Saphier, tabbed to become surgeon general.

Cassidy said on Sept. 24 that Kennedy, whom he voted for, made him guarantees but later backtracked on those promises, citing directives from the president.

Kennedy’s department did not return a request for comment.

Cassidy asked Overton how she would handle it if she made guarantees and the president then directed her to go against them.

“I’ve had robust discussions with the president,” said Overton, who was part of Trump’s first administration.

“I would give him my best advice, and I would follow the statutory requirements for the role of FDA commissioner regarding individual product determinations for safety and efficacy, and that would be what would guide every decision if confirmed to this role.”

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FDA Should Demand Proof, Not Just Protein, for Duchenne

On microdystrophin, the FDA is doing what the accelerated-approval standard has always required: asking that a biomarker be shown to predict real benefit before it is trusted.

Much of the commentary around REGENXBIO’s RGX-202 has framed the FDA’s stance as regulatory inconsistency, arguing that the agency is holding one sponsor to a standard it waived for another. But the question before the FDA is simpler: whether microdystrophin expression is actually strong enough to predict clinical benefit.

The charge of inconsistency does not survive contact with the record. And it is worth noticing that its loudest version comes from a sponsor whose commercial position gives it every reason to want the bar set lower.

Nor is REGENXBIO alone in having a commercial interest in how low that bar is set. Solid Biosciences is pursuing the same accelerated-approval opening for SGT-003 while emphasizing high microdystrophin expression and other biomarker results from its early-stage trial. Solid is still gathering the controlled functional evidence that can show whether those laboratory findings actually translate into meaningful improvement for boys with Duchenne. That is precisely why the FDA cannot allow impressive protein numbers themselves to become the standard of proof.

The problem is larger than any one company. If microdystrophin expression can secure accelerated approval without convincing evidence that it predicts how patients actually function, every sponsor developing a similar therapy has an incentive to race toward the biomarker rather than wait for the harder clinical answer.

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FDA relied on broken data mining process to sell COVID vaccines: report

Top officials with the U.S. Food and Drug Administration (FDA) were warned in early 2021 of a critical defect in the country’s vaccine monitoring system yet chose to rely on it anyway while assuring the public of the COVID-19 vaccines’ safety, according to a new report.

On September 16, the British Medical Journal (BMJ) published a report detailing flaws in the algorithms used to sift through the federal Vaccine Adverse Event Reporting System (VAERS) to find safety signals with the COVID shots that would require investigation.

One of those algorithms would calculate “proportional reporting ratios” (PRRs), identifying events that were reported at a higher rate than others, along with “empirical bayesian” data mining.

But according to the BMJ’s investigation, the agency’s algorithm was “mathematically compromised by the deluge of covid vaccine adverse event reports – resulting in a near total loss of signal detection sensitivity for the new mRNA vaccines made by Pfizer and Moderna.” More significantly, top officials were warned early in 2021, yet chose to keep relying on it anyway, and even “cited the absence of signals when assuring clinicians and the public of the vaccines’ safety.”

In February 2021, the Israeli Ministry of Health informed the FDA and CDC of a “a large number of reports of myocarditis, particularly in young people” after vaccination, and followed up five weeks later that two of the 77 had died. The Pentagon Defense Health Agency subsequently reported a “cluster” of myocarditis cases among male soldiers. By May, VAERS had gotten hundreds of such reports, prompting the CDC to begin alerting medical professionals.

Then-FDA Center for Biologics Evaluation & Research director Peter Marks emailed CDC director Rochelle Walensky, expressing concern that “myocarditis and pericarditis have not actually signaled … Can you help me understand why we are doing this when pediatricians and others in the community already seem to be aware?”

As VAERS reports continued to mount, health officials inquired as to why they were not receiving safety signals from the government.

“The problem arose because, in the first year of the rollout, almost all the reports coming into VAERS – more than 90% of 1.1 million – were for the mRNA covid shots, dwarfing vaccines for all other diseases,” BMJ explained. “This meant that analyzing the safety of one vaccine, for example Pfizer’s product, involved comparing it to other vaccines, which were overwhelmingly limited to Moderna’s product. But if both mRNA vaccines elevated the risk of an adverse event like myocarditis in roughly equal amounts, the ‘observed’ frequency and ‘expected’ frequency would be similar, resulting in no automated alert. The statistical phenomenon is known as ‘masking.’”

Microbiologist and immunologist Ana Szarfman, an expert in drug safety data mining who worked with the FDA for decades, emailed Marks directly with concerns about the system. Two weeks later, a video conference was held in which Szarfman’s presentation explained that the PRR analysis “Highlights almost everything,” whereas the FDA’s bayesian approach did not: “You are not getting useful information with such low counts.”

Yet Marks and his team declined to change course and urged Szarfman to “hold off on creating and sending data mining reports and analyses using covid-19 vaccine AE (adverse event) data.”

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FDA Using Taxpayer Dollars to Buy Young Baboons for Infection Experiments in Maryland

The Food and Drug Administration is buying up young baboons with taxpayer dollars so researchers can infect and kill them for research in Maryland.

White Coat Waste Project has released a new report detailing how the agency issued a $368,626 purchase order on August 31 to buy 20 baboons for pertussis experiments at its Maryland primate laboratory.

An active protocol allows the lab to use up to 48 animals.

Some of the baboons will receive experimental vaccines or antibodies. Others will get no protection at all. Then researchers will pump the bacteria that cause whooping cough into their windpipes and noses.

The primates will be subjected to violent coughing, vomiting, breathing problems, fever, weight loss, nasal discharge, and weeks of illness.

Staff will draw blood and swab noses and throats again and again.

Some of the animals will be killed and dissected so researchers can examine their lungs, windpipes, and lymph nodes.

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New Records Show Obama Admin Purchased Aborted Babies’ Heads for $515 Each

Judicial Watch announced today that it received 198 pages of records and communications from the U.S. Food and Drug Administration (FDA) involving “humanized mice” research with human fetal heads, organs and tissue, including communications and contracts with human fetal tissue provider Advanced Bioscience Resources (ABR). Most of the records are communications and related attachments between Perrin Larton, a procurement manager for ABR, and research veterinary medical officer Dr. Kristina Howard of the FDA.

Judicial Watch received the records through a March 2019 Freedom of Information Act (FOIA) lawsuit against the U.S. Department of Health and Human Services, of which the FDA is a part (Judicial Watch v. U.S. Department Health and Human Services (No. 1:19-cv-00876)). The lawsuit asks for all contracts and related documentation on disbursement of funds, procedural documents and communications between FDA and ABR for the provision of human fetal tissue to be used in humanized mice research. After successfully opposing the FDA’s redaction of certain information from its records, a federal court ordered HHS to release additional information about its purchases of organs harvested from aborted human fetuses – including “line item prices,” or the price per organ the government paid to ABR. The court also found “there is reason to question” whether the transactions violate federal law barring the sale of fetal organs. Documents previously uncovered in this lawsuit show that the federal government demanded the purchased fetal organs be “fresh and never frozen.”)

The records include an FDA generated contract with ABR, based on a “requisition” it issued on July 27, 2012, for $12,000 worth of “tissue procurement for humanized mice,” indicates the requisition was for a “non-competitive award.” Although the initial award was for $12,000, the total estimated amount of funds allocated for the requisition was $60,000. Under “Justification for Other than Full and Open Competition,” the FDA writes:

Scientists within the FDA and in the larger field of humanized mouse research have searched extensively over the past several years and ABR is the only company in the U.S. capable of supplying tissues suitable for HM research. No other company or organization is capable of fulfilling the need.***

Costs are estimated [for the fetal parts] at $230 per tissue x two tissues per shipment = $460 plus $95 shipping = $555 per shipment. A total of 21 shipments = $11,655.00.

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Inside the Safety Record Behind Israel’s Early Myocarditis Warning to Global Health Authorities

On February 28, 2021, Israel’s Ministry of Health alerted health authorities on both sides of the Atlantic to an emerging cardiac safety signal following the Pfizer Covid-19 vaccine.

The warning came just over two months after Israel had launched one of the fastest vaccination campaigns in the world, placing the country at the forefront of the global rollout.

That day, the Ministry informed the European Medicines Agency that it was investigating a “safety signal of myocarditis/peri-myocarditis in the younger population (16–30 years old)” and had already received reports of around 40 cases. A CDC internal tasking memo from the same day recorded that Israel was seeing “a large number of reports of myocarditis, particularly in young people,” and was seeking contacts at the CDC and FDA to discuss the issue. The message was marked “Importance: High.” 

Three days later, Dr. Roee Singer, Deputy Director of Epidemiology at Israel’s Ministry of Health, wrote directly to the CDC: “We are seeing a large number of myocarditis and pericarditis cases in young individuals soon after Pfizer COVID-19 vaccine. We would like to discuss the issue with a relevant expert at CDC.”

It was, in every sense, a “Houston, we have a problem” moment.

The alarm had been sounded. But what, exactly, had Israeli health officials seen that prompted it? And when, and how, was that warning communicated to physicians and the public?

Our newly published study in EXCLI Journal discloses and analyzes an internal Israeli Ministry of Health pharmacovigilance dataset that had never been made public. The dataset was provided to us by a whistleblower whose identity we are protecting. The file itself was titled, in Hebrew, “Reports of Hospitalizations and Deaths to Pfizer,” and contains detailed case-level reports documented by the Ministry of Health during the vaccination campaign.

The record was not reconstructed years later, after vaccine-associated myocarditis had become an established safety concern. It was being built in real time as the signal emerged. 

The dataset provided to us comprised eight cumulative versions, all sharing an original creation date of March 25, 2021. The record was updated repeatedly for more than a year as new cases were added and existing reports were revised with additional clinical information. The final version extends through May 9, 2022.

Already on March 25, just over three weeks after Israel first sounded the international alarm, the record contained 157 hospitalization reports and 46 death reports. Sixty-five of the hospitalization reports involved myocarditis or pericarditis.

By the final version of the dataset, myocarditis or pericarditis appeared in 250 of 531 hospitalization reports, nearly half. Among patients under 30, it appeared in 151 of 211 reports, more than 70%.

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FDA’s Botched Review of Moderna’s Flu mRNA Vaccine

When the FDA licensed Moderna’s new mRNA flu vaccine last week, legacy media coverage focused almost exclusively on efficacy.

The pivotal trial reported that the vaccine was “26.6% more effective” than a conventional flu vaccine at preventing protocol-defined influenza-like illness.

What received far less scrutiny was a much more serious problem in the trial data published in The New England Journal of Medicine—much of it relegated to an appendix behind a paywall.

An analysis of that appendix alongside the FDA’s own briefing document exposes clear regulatory malfeasance.

A statistically significant safety signal from the pivotal trial was systematically diluted until it disappeared from the official story.

The Safety Signal

Moderna’s pivotal Phase 3 trial (P304) enrolled roughly 40,000 adults aged 50 and older, randomised 1:1 to either the company’s mRNA-1010 vaccine or a traditional trivalent flu vaccine.

This study evaluated an “optimised” version of Moderna’s vaccine after earlier versions produced disappointing efficacy results.

Even with this updated formulation, the headline “26.6% relative efficacy” figure was misleading. In absolute terms, the vaccine reduced the risk of illness by just 0.8%.

Most concerning, however, were the serious adverse event (SAE) data.

The six-month data show that 449 participants in the mRNA group experienced at least one SAE, compared with 389 in the conventional group—an excess of 60 people.

So, while the pivotal trial showed there were 4 fewer influenza hospitalisations in the mRNA group, 60 additional people experienced an SAE.

SAEs are not mild events—they are usually severe enough to require hospitalisation, threaten life, cause significant disability, or result in death.

The imbalance of SAEs in Moderna’s pivotal trial was statistically significant—meaning it was unlikely to be a random fluke.

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Ex-FDA Commissioner Privately Told CIA That Up to 25% of Americans Had Already Achieved Natural Immunity Through Exposure to COVID by May 2020, Unclassified Document Reveals

Newly released documents are raising explosive questions about what pharmaceutical insiders and America’s intelligence community knew about COVID-19 immunity during the earliest months of the pandemic and why Americans were hearing a dramatically different story in public.

Senator Rand Paul (R-KY) released records detailing a May 7, 2020, CIA briefing involving Dr. Scott Gottlieb, the former FDA commissioner who had joined Pfizer’s board of directors the previous year.

Paul announced on X:

“I released documents showing Pfizer and the CIA privately acknowledged high population immunity as early as May 2020, while the public heard a different story. Americans deserve the truth.”

He pointed to reporting at Brownstone Institute on a newly unclassified CIA meeting summary buried in the latest tranche of records Paul entered into the congressional record.

The date on the briefing is May 7, 2020.

That is two months after the country was shut down. Churches closed. Small businesses crushed. Kids locked out of school. Fauci and Deborah Birx still talking as if this was a rare, novel threat that required indefinite emergency rule until a pharmaceutical product arrived.

Inside the CIA, they were already talking seroprevalence. Seroprevalence is the percentage or proportion of people in a specific population who have antibodies against a specific disease or infectious agent in their blood serum.

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FDA Approves Moderna XFG COVID Vaccines 81 Days Before Teen/Adult Safety Study, 126 Days Before Children’s Study

The U.S. Food and Drug Administration approved Moderna’s new XFG-formulated COVID-19 vaccines on August 27, 81 days before a human study specifically designed to evaluate the safety and immune response of the new formulations was scheduled to begin.

Pfizer’s XFG COVID vaccine formulation was approved on the same day, equally without safety data for its new formulation.

FDA approved the 2026–2027 formulas for Moderna’s SPIKEVAX and mNEXSPIKE vaccines, which are claimed to contain genetic instructions corresponding to the alleged JN.1-lineage XFG subvariant.

But FDA’s own Aug 27 approval letters show that a Phase 3b/4 human study specifically evaluating the “Immunogenicity and Safety of MNEXSPIKE and SPIKEVAX 2026-2027 Formula” is not scheduled to begin until November 16.

The first interim results are not due until March 26, 2027.

For younger children eligible to receive the new SPIKEVAX formulation, a separate human safety and immunogenicity study is scheduled to begin even later.

In other words, FDA approved Moderna’s new XFG vaccines first.

The human studies specifically evaluating the new formulations come afterward.

The regulatory pathway allows FDA to rely on claimed evidence from previously licensed formulations rather than require a new human safety trial of every updated formulation before approval.

But that raises consequential health, informed-consent, regulatory, and accountability questions:

  • How can FDA determine that a newly reformulated vaccine is safe before formulation-specific human safety data exist?
  • What evidence justifies carrying earlier safety findings forward to a changed product?
  • And why is FDA requiring a Phase 3b/4 study specifically to evaluate the new formulas’ “Safety” only after Americans are permitted to receive them?
  • And most fundamentally, if FDA is approving a newly reformulated vaccine before human safety data specific to that formulation exist, is the agency fulfilling its responsibility to independently establish that products are safe before Americans receive them, or shifting that uncertainty onto the public and collecting the answers afterward?

Congressional committees have confirmed that the FDA “is not meeting important federal safety requirements to protect its employees and the public while also failing to prioritize scientific data quality delivered from FDA laboratories.”

You can contact the FDA here.

And Moderna here.

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