Religion and Vaccine Arguments

[tim]

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.

[tim]

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.

It’s not exactly clear but some lipid nano particles used in American mRNA shots come from China.

[tim]

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.

[tim]

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?