Tag: influenza

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.

Keep reading

Does the Flu Vaccine Prevent Death?

Dear Editor,

My letter is concerned with a topic of utmost importance: The effect of the flu vaccine on flu-related death. That’s the ultimate endpoint of interest for vaccine effectiveness (VE) research, yet it is not captured in most studies that employ the test-negative design.

Faksova et al. (January 2026) reported in your journal results from a large cohort study of the flu vaccine in 2024–2025 in elderly residents (age≥65) of three Nordic countries. The estimated VE against flu-related death was 63%, which corresponds to a risk ratio (RR) of 0.37. How robust is the result? What does sensitivity analysis show?

The authors relied on a matched design to avoid confounding bias, a major threat in observational research. Unvaccinated members of the cohort were matched to the vaccinated (one-to-one matching) on several variables, including key comorbidities.

Sweden was not included in the mortality analysis (small numbers), and the mortality graphs were displayed by country (Denmark, Finland). I will examine the data from Denmark, a matched cohort of over one million people.

Graphs of cumulative mortality by vaccination status were displayed as of 14 days after a matched index date. For a vaccinated person, the index date was the vaccination date; for their unvaccinated counterpart, that matched date was just a random date on the calendar. I will return to this point later when we discuss their health status.

Keep reading

Was My Paper on Flu Vaccine Studies a “Hot Potato” for Editors?

Ithink the answer is “yes,” but here is the story for you to judge.

Each year the CDC publishes estimates of the effectiveness of the flu vaccine in the previous season. Reported by several networks, these estimates are based on a research design that is called a test-negative case-control study.

Over the years, the various authors have shared a similar analytical strategy: Early respiratory events were considered differently from later respiratory events (on the assumption that no effect is expected until immunity is built up). “Early” has typically been within two weeks post-vaccination.

Several months ago, I realized that this special handling of early events is a source of bias called “immortal time.” To expose the bias, I used causal diagrams, formally called “directed acyclic graphs (DAGs).” DAGs were introduced in landmark publications from the 1990s and are widely recognized in epidemiology as a methodological tool.

I wrote a short paper with a scary title: “Immortal time bias in test-negative studies of the flu vaccine.” I illustrated the bias by two simple DAGs that encoded the analytical approaches as described in those CDC-associated studies. The paper may be summarized in three bullet points:

  • Immortal time is an overlooked bias in test-negative, case-control studies of the flu vaccine.
  • The causal structure corresponds to misclassification bias or selection bias, depending on how early events were handled.
  • The bias can be avoided by considering all events and estimating built-up vaccine effectiveness by consecutive post-vaccination days.

I submitted the paper sequentially to three respected epidemiology journals. Surprisingly, the editor-in-chief of each journal rejected the paper within one week using boilerplate text. It was not sent for peer review. Why?

There are three possible reasons:

  1. The message was not sufficiently important.
  2. The paper was poorly written.
  3. Soliciting peer review was not needed. The editor decided that the bias did not exist. 

I can quickly eliminate the first reason. Exposing entrenched bias in studies of the annual flu vaccine is of utmost importance. I didn’t need to compete with any “more important” papers.

Was it poorly written? I have published many scientific papers and two books. I am not a newcomer to epidemiology and even served as an associate editor for one of the three journals. So, that was not the reason.

Keep reading

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].

Keep reading

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.

Keep reading

HHS So Confident an Influenza Pandemic Will Be Declared It’s Developing ‘Day One’ Vaccines, SAM.gov RFI Reveals

In a June Request for Information (RFI) titled “Protection Before Day One Vaccine: Advancing Broadly Protective Seasonal Influenza Vaccines with Pandemic Coverage,” the U.S. Department of Health and Human Services (HHS) is asking the biotechnology industry to develop influenza vaccines before the next pandemic begins, reflecting a level of planning that treats another influenza pandemic as a matter of when, not if.

HHS is therefore confident that there will be a future determination by authorities that an influenza pandemic has begun.

The proposal follows a series of federal future influenza pandemic-orchestrating initiatives, including Congress seeking $3.3 billion for a future influenza pandemic, HHS funding experiments determining how to make H5 influenza more pathogenic, HHS funding the creation of never-before-seen chimeric H6Nx bird flu viruses said to carry immune-evasion traits, and DARPA/NIH-funded scientists reprogramming dormant influenza parts with new replication and competition-suppressing functions.

It also comes after U.S. taxpayers funded the research behind Moderna’s new mRNA-1010 influenza vaccine and an FDA—which is under HHS—advisory committee backed the shot despite providing less than a 1% absolute benefit.

The initiatives raise a fundamental national security question: Why is the government simultaneously investing in making influenza viruses more dangerous while preparing “Day One” vaccines for the influenza pandemic it appears to expect?

You can contact HHS here to ask why the agency is planning for another influenza pandemic while simultaneously funding research that seeks to increase the capabilities of influenza viruses (see list of many such projects at the end of this article).

The RFI lists Wendy Rehman (wendy.rehman@ati.org) as the “Primary Point of Contact” for the Protection Before Day One Vaccine project.

Keep reading

Moderna’s mRNA Flu Vaccine Gets Unanimous Thumbs-Up Despite Risks, Low Efficacy

A federal advisory committee today unanimously voted to endorse Moderna’s mRNA flu vaccine — just months after rejecting the company’s application on the basis that Moderna had not performed an “adequate and well-controlled” clinical trial.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC), which reviews scientific data on the safety and effectiveness of vaccines and other therapeutics on behalf of the U.S. Food and Drug Administration (FDA), voted 9-0 in dual votes to recommend approval of the vaccine for the 50-64 and 65-plus age groups.

Today’s votes took place after several hours of presentations based on the findings of Moderna’s Phase 4 clinical trial data for its mRNA-1010 vaccine. The trial compared the efficacy of mRNA-1010 to that of a conventional, non-mRNA flu vaccine.

Daniel O’Connor, founder and CEO of TrialSite News, told The Defender today’s favorable votes “may reflect the committee’s view that the benefit-risk profile is acceptable.” However, the vote “does not erase the fundamental concerns surrounding this application.”

“Significant questions remain about comparator selection, study design and whether the reported efficacy advantage represents a clinically meaningful improvement for patients or simply a statistical advantage within the framework of the trial,” O’Connor said.

According to an FDA briefing document prepared in advance of today’s meeting, “no major deficiencies were identified” with the vaccine for adults 50 and over. Citing the clinical trial data, the document states that the mRNA-1010 vaccine had a 26.6% relative efficacy rate in adults 50 and over, with similar rates for adults 65 and up.

The mRNA-1010 vaccine also showed a higher immune response than Sanofi’s Fluzone vaccine, the document noted. According to Fierce Biotech, these results met all of the FDA’s “pre-specified criteria for success” and bolstered Moderna’s application for approval.

Karl Jablonowski, Ph.D., senior research scientist for Children’s Health Defense, said today’s vote shifts mRNA-1010 safety monitoring to after licensure.

“VRBPAC meetings proceed to the beat of the rubber stamp. The unanimous vote guarantees a lot of really good questions of harm will have to be answered in the post-marketing period, when that harm manifests in the population,” Jablonowski said.

Moderna seeks traditional approval for the mRNA-1010 vaccine for the 50-64 age group and accelerated approval for the 65-plus age group.

Fierce Biotech reported that the FDA uses VRBPAC meetings to “seek outside counsel on tough or high-profile regulatory decisions.”

The FDA will make an approval decision on mRNA-1010 by Aug. 5 — and while the agency is not bound to VRBPAC’s votes, it “often follows the opinions” of its advisory committees.

Moderna’s stock was up over 4% in trading immediately after the vote, and up 3.50% at the close of market.

mRNA vaccine had higher rate of adverse events than conventional flu shot

Keep reading

The great FLU ILLUSION: Bombshell study proves transmission is a myth and PCR tests are junk science

Virology misunderstood

If the flu virus is as contagious as we have been told, transmission should have been rampant. It was not. Only one recipient out of 75 became infected. That is a 1.3% secondary attack rate. The researchers expected at least 16%. They missed their target by more than tenfold.

To shed further doubt on virus transmission and the common measures used to protect against viral shedding, the study divided recipients into two groups. The intervention group wore face shields and sanitized their hands every 15 minutes. The control group did neither. The result? Zero infections in the intervention group and one infection in the control group. Statistically, there was no difference between the groups. This finding renders the entire mask debate moot. If face shields and constant hand sanitizer cannot stop transmission when both groups fail to get infected anyway, what exactly are we protecting ourselves from?

Virus transmission appears to be an imaginary concept, driven by fear and hysteria.

The uncomfortable truth about viral shedding

Now, forty-two of the 52 donors who were deliberately infected actually became infected after inoculation. That is an 81% infection rate through direct inoculation. And they shed virus from their noses in substantial quantities. Their viral loads were high enough to register on PCR tests with cycle threshold values in the mid-20s. Yet, remarkably, they did not pass the virus to the people sitting next to them. The researchers also measured the exhaled breath of donors using a device called the Gesundheit-II. They found that only 11 out of 42 infected donors had detectable virus in their breath aerosols. Even then, the quantities were two to four logs lower than what has been observed in naturally infected people who were selected for having fever and high viral loads.

This raises an obvious question. If the virus is so hard to transmit in a controlled setting where infected people are breathing directly onto susceptible people for days, how does it ever spread in the real world? The researchers tried to explain their failure by pointing to the building ventilation system. The proof-of-concept study was conducted in a hotel room with recirculating air, and it did have a higher transmission rate. The follow-on study used mechanical ventilation that diluted the air. They concluded that aerosols might be important after all. But this explanation is circular. If transmission depends on airtight rooms with no fresh air, then the virus is not a robust airborne pathogen. It is a fragile entity that requires extreme conditions to move from one person to another.

The fallacy of the contagious patient

The study also revealed something that should make every public health official reconsider their assumptions. Many of the directly infected donors did not get sick. Ten out of 42 infected donors were classified as asymptomatic. They had the virus in their bodies; it was confirmed through PCR; they shed it from their noses, but they felt fine. No fever, no cough, no runny nose. Yet they were placed in rooms with susceptible people and still did not transmit. The researchers admitted that their model produced donors who were “minimally contagious.” But if a person with a laboratory-confirmed infection who is breathing on you for 15 hours a day cannot make you sick, what does that say about the millions of asymptomatic cases that were used to justify lockdowns, school closures, and mask mandates?

The collective pandemic protection measures were not based on science; they were only used to control people, weaponizing their virtue and their fear.

Keep reading

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.

Keep reading

Study Finds Pediatric Flu Shots are a COMPLETE FAILURE

A new peer-reviewed study evaluating the rollout of mass pediatric flu vaccination across an entire Spanish health region (~400,000 people) found NO statistically significant reduction in flu cases or hospitalizations after authorities expanded flu shots to children 6 months to 5 years old.

Researchers analyzed 6,804 primary care influenza diagnoses and 3,252 influenza-related hospitalizations between 2018 and 2025, comparing seasons before and after the pediatric flu shot program began in 2023.

Despite the rollout, the study’s more rigorous interrupted time series analysis found no measurable reduction in influenza diagnoses or hospital admissions among the target age groups (0–2 and 2–4 years).

In plain English: the flu shots did not meaningfully lower flu rates in young children. Kids under 5 were no less likely to show up at the doctor with the flu or end up hospitalized than expected after the rollout. In other words, the program failed to produce a measurable real-world benefit in the exact age group it was designed to protect.

Notably, researchers also looked across all age groups in the region to see whether vaccinating young children indirectly protected the broader community. Again, they found no statistically significant reduction in flu-related hospitalizations or meaningful population-level benefit following rollout.

The study ultimately concluded that routine pediatric influenza vaccination “has not been associated with a reduction in influenza cases in primary care or hospital settings.”

These results are not surprising given that the Cleveland Clinic recently found that flu shots were associated with a 27% higher risk of flu among healthcare workers during the 2024–2025 season.

Keep reading