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Aug 22, 2026, 16:33

Nicolas Hulscher: FDA Data Reanalysis Raises Alarms Over Moderna’s MFLUSIVA

Nicolas Hulscher, Epidemiologist and Foundation Administrator at the McCullough Foundation, shared a post on X about recent article he and his colleagues co-authors, published in Zenodo, adding:

“Breaking:

FDA data reanalysis sent to secretary kennedy finds Moderna’s mRNA flu shot approval should be immediately withdrawn.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.

To prevent just one influenza hospitalization, 5,017 people had to be vaccinated at the cost of: about 2 excess unexplained deaths about 278 disabling Grade 3 systemic reactions about 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.

Unexplained deaths were 2.55 times more frequent among mFLUSIVA recipients, while disabling Grade 3 systemic reactions were 6.15times more frequent than with the standard-dose flu vaccine.

Literally every single solicited adverse event was more frequent in the mFLUSIVA group.

Neither pivotal trial included a placebo arm, and no influenza-mortality endpoint was ever measured.

Moreover, mFLUSIVA commits recipients to annual lifelong exposure to nucleoside-modified mRNA technology despite evidence of residual DNA contamination, genomic integration, protein misfolding, proteostatic collapse, body-wide biodistribution, years-long persistence, and compounded biological injury with repeated dosing.

Our study and accompanying information were sent directly to Secretary Kennedy and officials at HHS, FDA, CDC, and NIH. We hope Secretary Kennedy and federal health officials make the life-saving decision to remove this extremely hazardous product from the market before widespread administration begins. In light of the evidence now before them, allowing mFLUSIVA to remain approved would be a grave mistake.

The government has been given the data. It now has the responsibility to ACT.”

Title: Reanalysis of FDA Clinical Data for mFLUSIVA (mRNA-1010): Unfavorable Risk-Benefit Profile Supports Market Withdrawal Nicolas

Authors: Nikolas Hulscher, Peter A. McCullough, John A. Catanzaro

Nicolas Hulscher: FDA Data Reanalysis Raises Alarms Over Moderna’s MFLUSIVA