Australia's medicines regulator is considering Moderna's mFLUSIVA, a new mRNA vaccine for seasonal influenza. Its pivotal trial contained no inert placebo, severe reactions preventing normal daily activity were far more common than with the conventional shot, and America's regulator has demanded continuing surveillance of deaths and serious neurological and cardiac conditions until 2031.
These are not rumours pulled from some anonymous internet post. They come from the drug's clinical trial and the US Food and Drug Administration's own 123-page review.
In the trial's solicited-safety group, grade-three or worse systemic reactions were recorded in 5.5 percent of mFLUSIVA recipients, compared with 0.9 percent among those given a conventional flu vaccine. Grade three meant the reaction stopped the person from carrying out normal daily activities. Severe local reactions were reported in 1.7 percent, compared to 0.1 percent.
The more familiar side effects were also substantially higher. Injection-site pain affected 65.8 percent of mFLUSIVA recipients compared with 29.8 percent in the conventional-vaccine group. Fatigue was reported by 45.1 percent versus 20.3 percent, headaches by 37.8 percent versus 18 percent, and muscle pain by 35.4 percent versus 11.6 percent.
Moderna's line will be that most reactions were temporary and rated mild or moderate, but the spin does not bury the fact that a sizeable group experienced reactions severe enough to prevent ordinary activity.
Investigators judged three serious events in the mFLUSIVA group to be vaccine-related. Fatal events also occurred in the main trial.
The FDA's wider pooled safety analysis deserves closer attention. It found 29 deaths recorded without a specified cause among mRNA-1010 recipients, compared with 12 among people who received comparator vaccines. The FDA acknowledged that a definitive assessment of causation to the drug was impossible without autopsy data, but ordered Moderna to conduct post-market surveillance examining deaths, myocarditis, pericarditis, myopericarditis, and Guillain-Barré syndrome. That final report is not due until December 2031.
The main trial compared mFLUSIVA with an existing influenza vaccine rather than saline. Active controls are common when a vaccine is already available, but the design leaves an obvious hole. It shows how Moderna's product compares with another shot, not how either compares with an inert injection or no vaccination.
What benefit was gained in exchange for the extra reactions? Laboratory-confirmed influenza-like illness occurred in 2 percent of mFLUSIVA recipients and 2.8 percent of those given the conventional vaccine. Moderna calls that 26.6 percent greater relative efficacy. The absolute difference was 0.8 percentage points.
For Americans aged 65 and over, the FDA granted accelerated approval based mainly on immune response results from a separate trial. Clinical benefit for that age group must still be confirmed. Yet Moderna is asking the TGA to approve mFLUSIVA for all Australians aged 50 and above.
The TGA's public page currently gives almost none of this detail. If it approves mFLUSIVA, Australians deserve to know exactly how it assessed the sixfold severe-reaction rate, the missing inert placebo, the pooled death imbalance, and the unfinished safety studies.
Another bland assurance that the benefits outweigh the risks will not do.
https://nationfirst.substack.com/p/another-harmful-jab-set-to-be-approvedhttps://www.thefocalpoints.com/p/breaking-fda-approves-new-pfizer
"Pfizer's new COMIRNATY formulation was approved on August 27, 2026, while its prospective human study of the 2026–2027 formula is scheduled to begin August 31—four days later.
Moderna's new SPIKEVAX formulation was also approved on August 27, but its Phase 3b/4 human study of the 2026–2027 SPIKEVAX and MNEXSPIKE formulations is not scheduled to begin until November 16—nearly three months after approval.
FDA's own 2026 vaccine-selection materials distinguish between human data from earlier/current COVID vaccines and animal immunogenicity data for the new candidate vaccines.
Pfizer's FDA presentation shows the XFG candidate was tested in 10 mice per group.
Moderna's FDA presentation shows its key XFG experiment used 8 mice per group.
The approval letters reveal another troubling development: FDA also released both manufacturers from previously required placebo-controlled postmarketing studies, citing operational and feasibility problems. Pfizer's abandoned study would have investigated circulating spike antigen and post-vaccination symptoms, while Moderna's would have evaluated safety of variant-containing formulations.
Rather than requiring new human data before approval, FDA relied in part on human safety and immunogenicity data from previous COVID-19 vaccine formulations and extrapolated that evidence to the newly updated XFG products, while the XFG-specific evidence itself remained preclinical.
This reliance on older-formulation data is especially concerning given the millions of deaths, injuries, and disabilities, along with demonstrated cardiotoxicity, neurotoxicity, carcinogenicity, body-wide biodistribution, and years-long persistence.
This is extremely worrisome and needs to be reversed immediately."