Tag: fda

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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Learn lessons from covid: do not take the mRNA flu “vaccines”

The FDA’s approval of Moderna’s mFLUSIVA marks another major expansion of modified mRNA technology. Approved on 5 August for adults aged 50 and older in the United States, the product is intended for use during the 2026–2027 influenza season and is expected to appear on shelves in the coming weeks.

This deserves immediate attention. Despite all of the harms we witnessed during the covid-19 “vaccine” rollout, the same dangerous technological platform is now being introduced into routine seasonal influenza inoculation. The United States may be first, but applications are also being considered elsewhere, making this an international issue. Please warn everyone of the dangers and do not take these injections.

From Covid to Seasonal Influenza

The covid-19 injections represented a dramatic departure from traditional vaccine technology. Rather than introducing an antigen directly, the mRNA products deliver tens of trillions of copies of foreign genetic code inside PEGylated lipid nanoparticles, intended to cause the recipient’s own cells to manufacture foreign proteins.

Many of us raised concerns about this technology before the covid-19 injection rollout began. Those concerns included the distribution of infinitely penetrating lipid nanoparticles throughout the body, the hyper-persistence of the modified mRNA, the continued production of foreign proteins and the high risk of serious adverse effects.

The safety signals reported following the covid-19 “vaccine” rollout only intensified those concerns. Before the covid-19 injections, there were typically only a few hundred deaths reported each year following vaccination in the United States. This is not accounting for underreporting. After the modified mRNA covid-19 injections were rolled out, this rose to tens of thousands of reported deaths within months, with higher numbers in those initial months than for all other vaccines, for all other diseases, over the previous 30 years combined. Not to mention, data shows the covid injections have a negative efficacy; they increase the risk of covid infection. They produced only harm, no benefit.

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FDA Approves 3 New COVID-19 Vaccines

The Food and Drug Administration on Aug. 27 approved COVID-19 vaccines from Pfizer, Moderna, and Sanofi.

The new shots from Pfizer and Moderna use the messenger ribonucleic acid (mRNA) platform and target the XFG strain, a subvariant of the JN.1 variant.

Regulators also cleared a COVID-19 vaccine shot from Sanofi that targets the XFG strain and does not use mRNA technology.

The approval is for people aged 65 and older, as well as people aged 12 to 64 who have one or more underlying conditions such as obesity that officials say puts them at higher risk of severe COVID-19.

Regulators have been approving updated COVID-19 vaccines for several years, in a bid to better match circulating strains. The previous versions of the vaccines were estimated to provide 58 percent protection against hospitalization, according to the Centers for Disease Control and Prevention.

The FDA did not announce the approvals in a press release, as it has done in the past.

The FDA and its parent agency, the Department of Health and Human Services, did not respond to requests for comment by publication time.

Health Secretary Robert F. Kennedy Jr. has been critical of mRNA vaccines against respiratory diseases, saying they don’t work well.

Manufacturers are going to run single-arm studies evaluating the shots in humans, according to FDA documents. The companies were going to be made to run placebo-controlled trials, but officials released them from that requirement “because of operational and feasibility challenges,” the documents said.

FDA officials in 2025 said that new placebo-controlled trials were imperative to determine how well the COVID-19 vaccines actually performed, given it has been years since such trials were conducted. Pfizer and Moderna committed to running placebo-controlled trials, as did Novavax, which has since licensed its COVID-19 vaccine to Sanofi.

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FDA Acting Commissioner Woodcock Admits Adverse Events After COVID-19 Vaccination

This one email from FDA Acting Commissioner Janet Woodcock in May 2021 epitomizes everything wrong with our government’s treatment of vaccines and the vaccine injured.

Woodcock emails Fauci and Collins (head of NIH) to inform them that “a number of people” including healthcare workers she personally knows contacted her about injuries from every one of the available Covid-19 vaccines. She admits that:

(1) these injuries would not be picked up by FDA or CDC surveillance systems;
(2) there is no money set aside to study these harms (while billions are given to pharma companies for vaccines);
(3) no one will take these injured people seriously;
(4) no one knows how to treat them;
(5) there is no effort to study this serious issue; and
(6) “the industry” will not support the necessary studies.

I also agree with her sentiment that, “if you let a problem fester, then it will come back to bite you later…” Later is here.

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FDA Approves Moderna’s mRNA Flu Vaccine for Adults 50 and Older

FDA Approves Moderna’s mRNA Flu Vaccine for Adults 50 and Older

The U.S. Food and Drug Administration approved Moderna’s mRNA influenza vaccine, mFLUSIVA, for adults aged 50 and older, marking the first time the agency has licensed an mRNA vaccine for seasonal influenza, according to a company statement reported by The Epoch Times [1]. Moderna said the FDA granted traditional approval for adults aged 50 to 64 and accelerated approval for adults 65 and older.

The approval followed a unanimous 9-0 recommendation from the FDA’s Vaccines and Related Biological Products Advisory Committee [2]. The FDA had initially declined to review the application over concerns about trial design before reversing course after a high-priority meeting, according to a report by NaturalNews.com [3]. Moderna CEO Stéphane Bancel called the approval “our fourth approved product in the United States and the first mRNA-based flu vaccine” [4].

Approval Conditions and Trial Data

Moderna said the approval was based on a late-stage trial of more than 40,000 adults aged 50 and older that found the shot was 26.5 percent more effective than a licensed standard-dose flu vaccine. The company agreed to run an additional study and submit further data on adults 65 and older to demonstrate the vaccine’s benefit in that age group, and Moderna also submitted separate late-stage data showing stronger antibody responses than Sanofi’s high-dose flu vaccine in adults 65 and older after problems with the phase 3 trial methodology, according to The Epoch Times [1].

The vaccine uses mRNA technology intended to prompt the body to produce influenza antigens and trigger an immune response. Scientists said the approach could allow faster updates of the shot to match circulating strains [1]. In a 92-page review document, FDA reviewers said the trial’s use of a standard-dose comparator limited interpretation of clinical benefit for adults 65 and older. “This limitation affects interpretation of the net clinical benefit in the 65 and older population and is a key issue for Advisory Committee deliberation,” the reviewers wrote [1].

Adverse Events, FDA Review and Disclosures

The trial found higher rates of adverse events among mFLUSIVA recipients than among recipients of the comparator vaccine, with side effects including fatigue, headache, and muscle pain, according to FDA reviewers cited in The Epoch Times report. Serious adverse events occurred in 2.2 percent of mRNA vaccine recipients, with three events considered vaccine-related, compared with 1.9 percent in the comparator group [1].

A French peer-reviewed study published in 2022 concluded that mRNA COVID-19 shots increased the risk of myocarditis and pericarditis, particularly in adolescent and young adult males after a second dose, the report said [1]. The report also noted that multiple FDA advisory committee members who voted in favor of the flu vaccine had connections to Moderna, including El Sahly and Dr. Flor Munoz, who was a Moderna adviser from 2022 to 2024 [1].

Regulatory and Policy Context

Health Secretary Robert F. Kennedy Jr., who oversees the FDA, announced in August 2025 that the Department of Health and Human Services was winding down mRNA vaccine development under the Biomedical Advanced Research and Development Authority. Kennedy said funding would be redirected toward “safer, broader vaccine platforms that remain effective even as viruses mutate” [1]. In July 2026, HHS said Kennedy had signed determinations terminating the COVID-19 Emergency Use Authorization declarations for drugs, biological products, and medical devices [5].

Several FDA officials who had voiced opposition to mRNA vaccines have recently departed the agency, according to The Epoch Times [1]. An investigation by TrialSite News reported that regulators reviewing COVID-19 mRNA vaccines possessed data showing the products could travel throughout the body, even as the public was told the vaccines stayed “in the arm” and disappeared within a day or two [6]. Moderna withdrew its application for a COVID-flu combination shot last year after the FDA sought additional evidence, and European regulators approved the combination shot in April, the report said [1].

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FDA Reverses Course, Approves Moderna’s Experimental mRNA Flu Vaccine Months After Initial Rejection

The Food and Drug Administration (FDA) has approved Moderna’s experimental mRNA influenza vaccine, reversing an earlier decision that blocked the application over concerns about the company’s clinical trial design.

The approval marks a significant turnaround after regulators, under Health and Human Services Secretary Robert F. Kennedy Jr., initially refused to even review Moderna’s submission.

Officials at the time said that the company had failed to compare its vaccine against what officials considered the best available standard of care.

Back in February, FDA vaccine chief Dr. Vinay Prasad concluded that Moderna’s study was not “adequate and well-controlled” because it used GlaxoSmithKline’s Fluarix Quadrivalent vaccine as its comparator rather than a stronger-performing alternative.

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Sanofi Made False Claims About RSV Shot for Infants, FDA Says

In a letter to the drugmaker, the FDA said the agency approved Beyfortus, an RSV monoclonal antibody, as a defense against RSV lower respiratory tract disease — but that Sanofi has been claiming it protects broadly against RSV disease, which occurs in the lower and upper tracts. Beyfortus has come under scrutiny following reports of at least two infant deaths during clinical trials for the drug.

The U.S. Food and Drug Administration (FDA) is accusing Sanofi of making false or misleading promotional claims about Beyfortus, a preventative treatment for RSV, Fierce Pharma reported.

In a letter to the drugmaker, the FDA said it approved Beyfortus specifically as a defense against respiratory syncytial virus (RSV) lower respiratory tract disease — but that Sanofi has been claiming it protects broadly against RSV disease, which occurs in the lower and upper tracts.

The company has sent providers emails urging them to give the shot to “help prevent RSV disease in infants.”

The promotional materials included other similar statements, including, “Beyfortus is a monoclonal antibody that helps prevent RSV disease starting from Day 1 after injection,” and “Your efforts in immunizing infants against RSV disease can impact the population health burden in your community.”

The FDA said that language creates the “misleading impression” that the drug prevents RSV disease generally.

FDA asks Sanofi to take immediate action to stop misbranding RSV shot

Beyfortus, a monoclonal antibody manufactured by Sanofi and AstraZeneca, was approved by the FDA in 2023. Unlike a vaccine, monoclonal antibodies provide passive immunity by delivering laboratory-produced antibodies designed to protect infants against severe RSV disease.

The FDA emphasized that Beyfortus is specifically approved for the prevention of RSV lower respiratory tract disease — not RSV infection or upper respiratory tract illness generally.

The agency noted that while the promotional emails later referred to protecting infants from “RSV-LRTI,” lower respiratory tract infection,  that clarification did not adequately correct the overall impression created by the broader claims appearing earlier in the communications.

“By failing to adequately communicate the indication for Beyfortus, the emails create a misleading impression about the drug’s FDA-approved indication,” the letter states.

The agency concluded that the promotional materials “misbrand Beyfortus” under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The FDA requested that Sanofi take immediate action to stop disseminating the promotional communications or other materials containing similar representations.

The agency also instructed the company to submit a written response within 15 working days detailing all Beyfortus promotional communications containing comparable claims, along with its plan to discontinue or correct them.

If Sanofi believes its promotional materials do not violate federal law, FDA said the company may provide its reasoning and supporting evidence as part of its response.

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