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FDA wrote that interpretation of the mortality imbalance was limited by the absence of autopsy data. Then came the critical fact: no autopsies were performed on the mFLUSIVA deaths. Causes were recorded predominantly as unknown or natural causes (FDA 2026a).

Let this sink in: twenty-three participants receiving mFLUSIVA died without a specified cause, significantly more than in the comparison group. FDA itself identified the absence of autopsies as limiting its ability to determine causation. Yet autopsies were not required in the protocol, when the imbalance appeared, or before licensure. The agency identified the evidence it lacked, knew this was a major weakness in the data, and then approved the vaccine without obtaining any answers.

FDA nevertheless concluded that the imbalance was unlikely to be vaccine-related. There are legitimate reasons for that judgment. Overall mortality was nearly equal between groups. The median death occurred about 131 days after mFLUSIVA vaccination compared with 87 days among comparators. Within 28 days, deaths in these categories numbered only three, compared with two. About 60 percent of those who died were 65 or older, and nearly all had substantial underlying disease, including hypertension, diabetes, kidney disease, coronary artery disease and heart failure.

Those facts raise questions about causation. They do not determine the cause of the unexplained deaths.

One case illustrates the distinction. A 76-year-old woman with coronary bypass surgery, atrial fibrillation and type 2 diabetes died two days after vaccination. The investigator at her trial site considered the death vaccine-related because of its timing. FDA considered her underlying cardiovascular disease the more plausible explanation, while acknowledging that a contribution from a vaccine-related inflammatory response could not be fully excluded. No autopsy was performed to resolve the disagreement. So despite the investigator labeling it as vaccine-related, the FDA did not.

This establishes that the FDA found a statistically significant imbalance in deaths without assigned causes and approved the vaccine without obtaining the evidence it said was necessary to interpret that imbalance. Mortality will now be monitored after licensure… Sound familiar?

A Standard Announced, and an Exemption That Does Not Fit

On May 1, 2025, the Department of Health and Human Services told the Washington Post that, under Secretary Kennedy, all new vaccines would undergo placebo-controlled safety testing before licensure. HHS called it a “radical departure” from previous practice (HHS 2025).

A placebo-controlled trial compares the vaccine with an inert injection, usually saline. An active-controlled trial compares it with another vaccine. The distinction determines what can be measured. Against saline, the adverse-event rate attributable to the vaccine can emerge against a relatively clean baseline. Against another vaccine, the trial measures only the difference between two products. If both produce the same adverse event at elevated rates, the comparison can obscure it.

HHS never issued the policy as a regulation or formal guidance. It announced it to reporters and immediately carved out an exemption. The department declined to specify exactly which vaccines the new requirement covered, but told the Post that influenza vaccines were excluded because they had been “tried and tested for more than 80 years.”

That exemption does not fit mFLUSIVA.

The 80-year safety record belongs to conventional influenza vaccines. mFLUSIVA is the first licensed influenza vaccine built on an mRNA-lipid nanoparticle platform. The influenza antigen is familiar; the technology used to deliver the genetic instructions for producing it is not. HHS defined the exemption by the disease being vaccinated against rather than by the technology of the vaccine itself. It therefore extended the safety history of conventional flu vaccines to a platform never before licensed for influenza.

Moderna did use saline once, in its small first-in-human study, to evaluate safety and immune response. It never tested mFLUSIVA’s clinical efficacy against saline. Not once. Every efficacy trial compared mFLUSIVA with another influenza vaccine, and the early saline-controlled safety study was never repeated at Phase 3 scale.

That distinction matters because Kennedy’s announced policy was supposed to answer precisely the safety question an active comparator cannot fully answer: what does a new vaccine add compared with an inert control? For mFLUSIVA, FDA never obtained that answer at scale.

Kennedy promised placebo-controlled testing for new vaccines. His department then treated the first mRNA influenza vaccine as though it were not new, because influenza vaccines themselves are old. FDA licensed a novel vaccine platform under the inherited safety reputation of products built with different technology.

The mechanistic question is less settled. The influenza vaccine changed the antigen while retaining the basic mRNA delivery platform, yet reactogenicity remained high. That provides evidence that the spike protein cannot, by itself, explain the reactions seen with COVID mRNA vaccines. It does not tell us which component of the remaining platform is responsible. No influenza trial has independently varied the modified mRNA and lipid nanoparticle components in a way that would answer that question.

I attributed the remaining reactogenicity to the modified mRNA and the lipid nanoparticles carrying it into cells. Five years later, the evidence points more strongly toward the lipid nanoparticles. They are not inert packaging. The ionizable lipids used to deliver mRNA can themselves activate innate inflammatory pathways, and experimental studies have demonstrated inflammatory responses to LNP formulations even in the absence of the encoded antigen. What remains unresolved is how much of the clinical reactogenicity comes from the LNP, the mRNA-LNP interaction, antigen expression, or other components of the formulation.

What made these results particularly important was that they offered a rare opportunity to separate the effects of the mRNA platform from the effects of the COVID spike protein. The COVID shots produce spike, and much of the concern about their side effects centered on that protein. Moderna’s flu candidate produced a different protein entirely, an influenza surface protein called hemagglutinin. Same delivery system, different cargo. If the side effects remained high after swapping out the cargo, then spike could not be the whole story. I attributed the remainder to the modified mRNA itself and to the synthetic fat particle that carries it into cells.

But the coded categories encompassing unexplained death, sudden death, and sudden cardiac death occurred 29 times after mFLUSIVA and 12 times after comparison vaccines. FDA identified the imbalance, said the absence of autopsy data limited its ability to determine the causes, and nevertheless judged it unlikely to be vaccine-related.

No autopsies were performed on the mFLUSIVA deaths. This does not establish that mFLUSIVA caused them. It establishes that FDA identified an unexplained mortality imbalance, identified the evidence missing from its evaluation, and licensed the vaccine without obtaining that evidence.

MODERNA'S mRNA FLU SHOT
FDA REFUSED IT, THEN REVERSED ITSELF IN TWO WEEKS

The Executive Summary: What This Essay Shows

On August 5, 2026, FDA licensed mFLUSIVA, Moderna’s first mRNA influenza vaccine. For Americans 50 through 64, it granted traditional approval. For those 65 and older, the population that accounts for roughly 70 to 85 percent of American influenza deaths, FDA used accelerated approval.

The central fact of this essay is simple: FDA licensed mFLUSIVA for seniors without clinical evidence that it works better than the enhanced influenza vaccines seniors already receive. The study designed to answer that question begins after approval.

That was not FDA’s original position.

On February 3, FDA issued a Refusal to File letter because Moderna had not compared mFLUSIVA clinically with the enhanced vaccines preferentially recommended for older Americans. CBER director Vinay Prasad personally signed the refusal, overriding career vaccine reviewers who believed the application should be reviewed. Moderna made the letter public, challenged the decision, and called for White House intervention.

The White House intervened. FDA Commissioner Marty Makary was summoned to meet with President Trump. CNN reported that Trump berated him over the Moderna decision and that the confrontation prompted FDA’s reversal. A source close to the process told Politico that the subsequent meeting between FDA and Moderna provided the agency a way to reverse course publicly. Fourteen days after refusing the application, FDA accepted it without Moderna having performed the clinical comparison that triggered the refusal.

Within three months, Prasad was gone. Makary was gone. The vaccine-office director who had opposed the refusal remained and ultimately signed the license.

Moderna still has not performed that comparison. Instead, FDA granted accelerated approval for seniors and required a postmarketing study of as many as 800,000 people to determine how mFLUSIVA performs clinically against a vaccine preferentially recommended for them.

That reversal is the organizing fact of the regulatory record. The experiment FDA initially said was important enough to prevent the application from being reviewed became an experiment that could wait until after the vaccine was licensed.

BREAKING: Report Links Vaccines to the Explosion of Alpha-Gal Syndrome

More than 90% of U.S. children are injected with alpha-gal-bearing mammalian gelatin before school entry, raising the possibility of direct sensitization or immune priming before a later tick bite.

BREAKING: FDA Data Reanalysis Sent to HHS Finds Moderna’s mRNA Flu Shot Approval Should Be Immediately Withdrawn

We directly reanalyzed the FDA’s own data used to approve mFLUSIVA and found an extreme risk-benefit profile that is impossible to justify.

The answer is extraordinary. To avert ONE influenza hospitalization, approximately 5,017 adults had to receive mFLUSIVA instead of a standard-dose influenza vaccine, at the COST of:

~2 excess unexplained DEATHS

~278 disabling Grade 3 systemic reactions

~3,798 adverse reactions

Compared with the standard-dose flu vaccine, that amounts to approximately 1,454 ADDITIONAL adverse reactions and 233 ADDITIONAL disabling Grade 3 systemic reactions for every hospitalization prevented.

The broader safety pattern was just as one-sided. Unexplained deaths were 2.55-fold more frequent, Grade 3 systemic reactions were 6.15-fold more frequent, and every solicited symptom was more frequent in the mFLUSIVA group.

Neither pivotal trial included a placebo arm, and no properly adjudicated influenza-mortality endpoint was ever specified, collected, or reported.

In memory of those who “died suddenly” in the United States and worldwide, August 10-17, 2026

Activist Ward Churchill; music critic Dave Marsh; actress Christy Knowings (46, All That); reality stars Ryan de Nino (40), Tyler Duckworth (44); rocker Scott Sechman; singer Nikki Ross Bellamy; more

A survey of the likely global toll of COVID “vaccination,” based on the reports collected by our worldwide team of researchers this past week.

Vaccine Cartel Desperately Clings to New MMR Vaccine–Autism “No Link” Study Riddled With Major Flaws

No truly unvaccinated control group, no clinical autism adjudication, no parent interviews, no independent vaccine-record verification, and a narrow ICD-coded autism definition.