Tag: influenza

Needle-Free mRNA Vaccine With Aluminum Protects Mice Against COVID and Flu — But Study Lacks Safety Data

Scientists have developed a needle-free mRNA vaccine that protects mice against COVID-19 and flu and causes less inflammation than conventional formulations, according to a new study published in The Journal of Clinical Investigation.

The vaccines use a high-pressure liquid jet to deliver genetic material directly through the skin, unlike the Pfizer-BioNTech and Moderna COVID-19 shots, which use lipid nanoparticles as the delivery system.

The authors — researchers from Rutgers University and Japanese institutions — reported that the technology generated strong immune responses and reduced viral replication in vaccinated mice.

The vaccine hasn’t been tested in humans, and researchers haven’t established whether it could reduce serious adverse reactions.

“Showing that a carrier-free, needle-free vaccine can be made protective opens a different design space than the one the field has been working in,” said study co-author Renata Pasqualini, Ph.D., a Rutgers researcher, in a university announcement.

COVID vaccines linked to serious adverse events

The study comes amid continuing concerns about COVID-19 vaccine injuries, and a study released this week comparing Pfizer and Moderna vaccine mortality rates.

The Centers for Disease Control and Prevention (CDC) has recognized a causal link between mRNA COVID-19 vaccines and myocarditis and pericarditis, particularly among adolescent and young adult males.

A 2022 study published in JAMA identified 1,626 reports meeting the CDC’s case definition for myocarditis following mRNA vaccination during the study period.

Reporting rates were highest among adolescent boys after their second dose, reaching approximately 106 cases per million Pfizer doses among males ages 16 and 17.

Symptoms of myocarditis can include chest pain, shortness of breath and an irregular heartbeat. Although many patients recover, some require hospitalization, and others have reported being permanently disabled.

Other documented serious adverse reactions include anaphylaxis following vaccination and a rare blood-clotting disorder associated with Johnson & Johnson’s COVID-19 vaccine.

The federal Vaccine Adverse Event Reporting System (VAERS) collects reports of suspected vaccine injuries and deaths. The latest figures show 1,678,901 adverse event reports following COVID-19 vaccination submitted to VAERS as of Sept. 25, 2026, including 39,260 reported fatalities and 29,299 reports of myocarditis or pericarditis.

The Rutgers study did not investigate whether its mRNA needle-free vaccine could prevent serious injuries.

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Flu Vaccine Studies: Pseudo-Randomized or Untrustworthy Results?

The validity of a study, or a series of studies, may be questioned by several methods, one of which is identifying unexpected results. Consider the following example, which I used to teach in an introductory epidemiology course.

Having yellow-stained fingers is associated with lung cancer, but we know that the association does not reflect causality. Yellow-stained fingers do not cause lung cancer. Rather, the association is explained by smoking — a confounder — a cause of both yellow fingers and lung cancer.

Suppose a group of researchers reported that the association in question was not removed after adjustment for smoking status. Obviously, something is wrong, either in the data or in the way it was analyzed. Regardless of the reason, we will not trust any inference from that study, including the estimated effect of smoking. It is equivalent to rejecting a witness’s entire testimony after detecting a single relevant lie. That’s an analogy, of course, not a claim about intentional lying by the researchers.

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Can You Trust CDC’s Flu Vaccine Effectiveness Estimates? Epidemiologist Says No

Every year, the Centers for Disease Control and Prevention (CDC) estimates how effective last year’s flu vaccine was at preventing flu-related symptoms and hospitalizations.

But are the CDC’s estimates accurate? Can you trust them?

Dr. Eyal Shahar, a professor emeritus of epidemiology at the University of Arizona’s Mel & Enid Zuckerman College of Public Health, says no — because the CDC uses what he says is an inherently biased study design to arrive at those estimates.

In an interview with The Defender, Shahar said that for years, the CDC has insisted on using a “problematic” test-negative study design, even though better designs exist.

“There are many supporters of the test-negative design, and the CDC simply adopted that design long ago,” Shahar said. “There are CDC-associated networks, all of which exclusively use that design to estimate effectiveness. It is time for a change.”

Shahar has authored nearly 200 papers, a book chapter on biases in epidemiological research, and two books, including a textbook on epidemiology and statistics. He has taught courses in methodology and is the former associate editor of the American Journal of Epidemiology.

A test-negative study design method is relatively easy and cheap, but it is known to produce biased and incoherent results, Shahar said.

Test-negative studies on flu vaccine effectiveness enroll people who sought medical care for flu-like symptoms and were tested for the flu. The researchers compare the vaccination status between those who tested positive and those who tested negative.

But that means the study is limited to people who sought medical care and were tested. That’s a form of selection bias, because the study excluded everyone who didn’t do those things. Limiting the study in this way can also cause collider bias, which could skew the results, Shahar said.

Shahar said better study designs would likely yield more accurate results, but they require more effort and money.

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We Cannot Trust the CDC Estimates of Flu Vaccine Effectiveness

Each year the CDC publishes an estimate of the effectiveness of the flu vaccine in the previous flu season. Recently, the NIH director criticized the test-negative design from which the estimates are derived. He was right. The basic premise of the design is a two-edged sword: on the one hand, restricting the sample to people who sought medical care might reduce confounding by healthcare-seeking behavior; on the other hand, that restriction might add another type of bias — colliding bias — which is not as widely appreciated. The net bias remains unknown.

This, however, is not the only shortcoming of test-negative case-control studies of the flu vaccine. In this post, I will expose the shaky results of a large study of the flu vaccine in 2022–2023, when the vaccine was well-matched to the dominant strain. The study was based on the VISION Vaccine Effectiveness Network, one of several networks that collaborate with the CDC. Below are the published results.

Given a changing risk of infection, a valid comparison of the vaccinated and the unvaccinated requires similar distributions of the two populations over time. This is not the case because vaccination is associated with calendar time (rollout).

[The authors show the vaccination status at the time of seeking care, but most people got vaccinated by the end of December, and the percentage of vaccinated people stabilized in January at about 45% of the encounters.]

As shown below (Table), the share of the vaccinated population in October through December (47%), a period of high background risk, was lower than the comparable share in the unvaccinated population (61%). Of course, the complementary shares in January through March, a period of low risk, were reversed: 53% versus 39%.

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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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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.

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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.

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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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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.

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