Tag: fda

FDA, NYT Downplayed Evidence Showing Covid Shots May Have Killed Kids

Last fall, FDA safety officers began compiling a list of children possibly killed by Covid vaccines. Digging through thousands of reports of adverse effects and autopsy records of those who had died after receiving the mRNA vaccines manufactured by Moderna and Pfizer, the team eventually determined that several adolescents had apparently died from the Covid vaccines.

On Dec. 5, the team’s leader, Dr. Meghna Alimchandani, sent an email recommending changing the labels on all mRNA Covid-19 vaccines to notify patients of the risk for cardiac death (fatal myocarditis), adding that her safety team planned to present those results at an upcoming FDA meeting. Such warnings, even regarding rare outcomes, are standard procedure — as is well-known by everyone who has watched drug TV ads that run through long lists of known harms.

Ten months later, the FDA has still taken no action to warn parents.

A RealClearInvestigations inquiry found that a strange-bedfellows convergence of political interests appears to have blocked the dissemination of this scientific information. President Trump, whose Operation Warp Speed helped fast-track development of the vaccines in 2020, believes his efforts saved millions of lives, and several current and former health officials told RCI they are loath to complicate that narrative for him. RCI also found evidence that the Biden administration, a strong supporter of vaccine mandates, showed little interest in examining or publicizing mortality data that might undermine its policies. For its part, the pharmaceutical industry was intent on protecting its profits, and influential media outlets, especially the New York Times, have downplayed evidence of Covid vaccine deaths and attack those who’ve tried to bring them to light.

“In the end that’s the big story,” said Sen. Ron Johnson, who has sustained a years-long investigation into Covid vaccine safety, releasing hundreds of pages of internal FDA records that call into question the agency’s forthrightness and that the legacy media have largely ignored or dismissed. “Advertising allowed Big Pharma to not only capture our medical colleges, medical journals, and Congress, but now the media,” Johnson added. “They’ve run the table,” he said. “That’s why this isn’t covered.”

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Court-Ordered Confusion: CDC Now Recommends a COVID-19 Shot FDA Hasn’t Approved for Most Adults

The Centers for Disease Control and Prevention (CDC) is telling the nation’s doctors that every adult 18 and older should receive a 2026-2027 COVID-19 vaccine, despite the fact that the Food and Drug Administration (FDA) approved those same vaccines in August only for adults 65 and older and for younger people with at least one condition that puts them at high risk.

This is just one of the potentially deadly points of advice confusion that the Independent Medical Alliance (IMA), a national coalition of 20,000 independent physicians, researchers and healthcare professionals, is calling on to be removed from HHS websites.

“The CDC, FDA and the Department of Health and Human Services must immediately resolve this contradiction and instead err toward patient safety,” said Dr. Joseph Varon, President and Chief Medical Officer of the Independent Medical Alliance. “The CDC’s COVID-19 vaccine pages don’t match current FDA labeling and safety warnings. Instead, outdated advice that has since proven harmful, and even deadly, to patients is still being promoted. If pending court cases are an issue, then the CDC should immediately take down the content.”

Dozens of studies since the release of the mRNA platform have demonstrated elevated cardiovascular risks associated with the shot, particularly in younger men. Other side effects include unexplained resurgence of cancers in shot recipients, warranting extreme caution on recommending any mRNA product. The IMA’s Journal of Independent Medicine is quickly becoming the nation’s leading forum on examining the impacts of mRNA therapy.

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Nearly 40% of FDA Advisory Meetings Included Patient Representatives With Ties to Pharma

Nearly 40% of U.S. Food and Drug Administration (FDA) advisory committee meetings held between 2013 and 2022 included patient or consumer representatives affiliated with organizations funded by pharmaceutical companies, according to a study published this month in Health Affairs Scholar.

FDA advisory committees assess the safety and effectiveness of drugs, including vaccines, and make recommendations on whether the FDA should approve them.

Researchers Genevieve Kanter, Ph.D., and Toni Mankowitz of the University of Southern California found that 38% of the meetings included representatives of industry-funded advocacy organizations.

In 11% of meetings, representatives attended on behalf of organizations funded in part by the manufacturer whose drug the FDA was evaluating.

“These prevalence rates show that these organizational relationships extend beyond isolated cases and signal a broader problem warranting FDA policy attention,” the researchers wrote.

According to the FDA website, the agency has about 50 technical and scientific advisory committees and panels. Members include “science-oriented” professionals, including doctors, researchers, biologists, chemists, statisticians and others, selected for their expertise on a specific committee’s function and topic area.

In addition, the website states, “each committee typically includes a consumer representative and an industry representative and, based on the meeting topic, a patient representative who provides the patient or caregiver experience for a particular disease, condition, or medical product.”

According to the study, which focused only on potential conflicts of interest among consumer and patient representatives:

“Although the FDA has enacted policies to curb conflicts of interest common among its scientific members, it has paid less attention to potential conflicts arising from patient and consumer representatives who have ties to organizations financially supported by pharmaceutical companies.”

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“Very Concerning Safety Issues”: Trump’s mRNA-Skeptic FDA Drug Chief Was Mysteriously Fired – Right Before This Drug Was Approved

Within three months of firing Tracy Beth Høeg, its top drug regulator, the FDA had approved the first mRNA flu shot, cleared a Sanofi diabetes treatment for children that she had held up, and approved a twice-rejected melanoma drug whose maker went to the White House.

“I’m worried about approvals that we’ve seen recently, like the mRNA influenza vaccine,” Høeg told journalist Paul Thacker in an interview posted Wednesday, citing “very concerning safety issues.“

Of the melanoma drugmaker’s White House meeting, she said: “I guess that’s what you do now if you’re angry that your product is not approved. One has to wonder, is it approved based on the data or do they just know the right people?”

Høeg still doesn’t know who ordered her firing. When agency lawyers came to her office on May 15, three days after Commissioner Marty Makary was pushed out, she refused to resign. The lawyers told her the order came from “someone way above their pay grade.”

The person who supposedly wrote her termination memo denies writing it or ever seeing it, she says. Health Secretary Robert F. Kennedy Jr. only learned of the firing after she was gone, the New York Times reported.

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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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