Tag: moderna

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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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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Science by press release: Moderna cashes in on mRNA cancer vaccine without publishing trial results

hen the Food and Drug Administration approved Moderna’s mRNA flu vaccine, the first ever, two weeks ago, the pharmaceutical company that reaped billions from federal taxpayers with its mRNA COVID-19 vaccine didn’t wait for the agency to even publicly post the approval. Moderna rushed out the news at 10 p.m., with a 4% increase in its share price the next morning.

It was a promising market signal for a drugmaker whose revenue cratered following the collapse in demand for COVID vaccines, which also led Pfizer to cancel a trial this spring for its own updated mRNA COVID jab. 

What Moderna left out of the release Wednesday, and the media ignored: the mRNA flu jab’s disproportionately high rate of serious adverse events compared to a normal flu shot – the same problem with its Omicron-specific COVID vaccine three years ago – and the number of jabs required to prevent a single hospitalization, 5,000.

Yet the market and the media went crazy for Moderna this week when it announced “positive topline results” from a late-stage trial of its cancer vaccine with Merck, with a 177% spike in its share price on top of a 357% increase this year before the cancer vaccine news, despite no published trial data or FDA approval. 

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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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Moderna Has Found Another Virus to Monetize

Moderna is back at the public trough with another experimental mRNA vaccine, this time targeting the Bundibugyo strain of Ebola. CBC reports that Health Canada has authorized a Phase 1 trial of mRNA-1469 at three Canadian sites involving about 80 adults. Canada has never recorded a single Ebola case, and its government admits the risk to the general population is low, yet healthy Canadians will supply the human data for a product intended primarily for a third-world African nation.

As of August 1, there were 3,748 confirmed cases and 1,657 deaths in the Democratic Republic of Congo. There is no approved vaccine specifically targeting Bundibugyo Ebola, but Moderna is not financing this humanitarian venture alone. The Coalition for Epidemic Preparedness Innovations has pledged up to $50 million for preclinical research, Phase 1 testing, and manufacturing doses before the early trial is even complete.

This is public risk and private reward dressed up as charity. If the product fails, outside funding absorbs much of the loss. If it succeeds, Moderna gains another proprietary vaccine and governments or international organizations will purchase the doses. Moderna promises to make at least 500,000 doses available to poorer countries at “access pricing,” but it has not told the public what that price will be, or who will ultimately pay the bill.

COVID was perhaps the most profitable virus in pharmaceutical history. Moderna and Pfizer-BioNTech were once projected to generate between $93.2 billion and $124 billion in combined vaccine sales during 2022. Taxpayers helped finance development, governments guaranteed purchases, mandates manufactured customers, and Big Tech silenced those who questioned the arrangement. The corporations kept the profits while politicians treated the population like an obedient herd.

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Czech data shows that those who got the Moderna vaccine died more

For the first time, I show the directly standardized survival curves for each 5 year age group in the Czech Republic using the publicly released record-level data.

This data consistently shows the people who got the Moderna vaccine were much more likely to die than those of the same age who got the Pfizer shot. The relative risk (RR) was >1.5 for those under age 60 which is a huge difference.

The comorbidity distribution for both groups of a given age range was very similar (SMD=.05)

This isn’t because Pfizer is more protective of a COVID death because the differences were not specific to COVID periods (and were too large to be explained by effectiveness differences).

There are two remaining explanations:

  1. The Moderna vaccine was more deadly
  2. There was a systematic distribution of vaccines in Czech Republic that no matter what age you were, if you were more likely to die, you were given the Moderna shots.

Explanation is 2 is much less likely because there was no systematic bias in vaccine distribution by brand, and even if there were, the fact that the DCCI distributions were similar and that the younger you were, the more pronounced the effect, would be unusual since 45 year old people are not concentrated in elderly homes and hospital beds.

So the most likely explanation is Moderna was more deadly.

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Moderna Injects First Participant With Experimental mRNA-4200 Cancer Shot That Forces the Body to Produce Seven Undisclosed Tumor Proteins

On Thursday, Moderna announced that it has injected the first participant in a Phase 1 clinical trial of mRNA-4200 (NCT06880549), an experimental mRNA product that causes the body to produce seven undisclosed tumor proteins following administration.

In other words, the product does not merely introduce tumor proteins into the body—it uses the body itself to manufacture them.

On purpose.

The study raises obvious safety and informed-consent questions about how long the body produces the purportedly encoded tumor proteins, what their long-term biological effects may be, and whether the product or its outputs could be shed from the original recipient onto others through exosomes or extracellular vesicles in excreted bodily fluids.

A 2021 Journal of Extracellular Vesicles study found that cells expressing a target protein can release extracellular vesicles that “carry” that protein, demonstrating that what is produced inside the body can be exported outside the cell in membrane-bound particles.

A separate 2023 Pharmaceutics review explains that exosomes are natural transport vesicles that carry proteins and nucleic acids throughout the body and are present in bodily fluids including blood, saliva, and other secretions—meaning they are not confined to the original cell or even the original location in the body.

You can contact Moderna here and the FDA here.

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Despite Over 100 Deaths in Moderna’s mRNA Flu Trial – Committee Recommends that the FDA Move Forward with Approval

June 18, 2026: Moderna just announced that, “the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 9-0 that the benefits of mRNA-1010, Moderna’s investigational seasonal influenza vaccine, outweigh its risks for the prevention of influenza disease in adults 50 through 64 years of age and in adults 65 years of age and older.”

This is despite the fact that Moderna reported 102 deaths in the mRNA group and 97 deaths in the ‘enhanced vaccine’ group.

102 reported deaths out of 35,965 mRNA injected study participants equate to a 0.3% fatal adverse event (death) rate in less than a year of being injected.

Adults aged 50-64 have a 0.015% of dying from the flu vs. 0.3% from a flu injection = a 20-fold (1900%) increase).

Adults 65 and older have a 0.05% chance of dying from the flu vs 0.3% from a flu injection = 6-fold (500%) increase.

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SURPRISE: Moderna began work on Ebola mRNA vaccine just months ago

Well, what do we have here?

Not long ago I reported on how the vaccine maker Moderna had in fact begun development of an mRNA vaccine against hantavirus already in 2024.

What is also interesting is how they had a patent on a particular sequence that happened to also be in the covid virus. And this particular sequence is actually what made it unique and very infectious to humans. They got this patent years before the outbreak of covid.

Now, guess what?

The WHO has just declared a global health emergency over the Ebola outbreak that has happened in Africa.

Now the mainstream media has gone into full panic mode over Ebola, and it seems like the previous fearmongering over hantavirus just disappeared almost overnight.

Guess what I found?

Turns out that just some months ago Moderna began development of a new mRNA vaccine against Ebola with $26.7 MILLION in funding from an organization called CEPI.

This together with Oxford University who is also creating an Ebola vaccine on the same platform as the AstraZeneca covid vaccine.

Guess who is a major backer of this CEPI organization?

Bill Gates of course.

So what is going on?

Oh, and AI will be used to help develop this new Ebola vaccine to trigger a strong immune response.

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