FDA Data Reanalysis: Alarming Risk Signals
September 22 | Posted by mrossol | CDC NIH, FDA, Medicine, VaccineBREAKING: Our FDA Data Reanalysis Demanding Market Withdrawal of Moderna’s mRNA Flu Shot Is Now PEER-REVIEWED and PUBLISHED
The FDA’s own clinical data now sit in the peer-reviewed record showing a 155% higher risk of unexplained death, a 515% higher risk of disabling reactions, and an EXTREME risk-benefit imbalance.
I re-post this even though it seems there is some hyperbole. Need to dig into it further. mrossol
| NICOLAS HULSCHER, MPH SEP 21, 2026 |
Our reanalysis of the FDA clinical data used to approve Moderna’s new mRNA influenza injection (mFLUSIVA) has now been PEER-REVIEWED and PUBLISHED in the Journal of Independent Medicine.
This is the same study we previously sent directly to senior officials at HHS, FDA, CDC, and NIH, calling for immediate reversal of its authorization.
 | BREAKING: FDA Data Reanalysis Sent to HHS Finds Moderna’s mRNA Flu Shot Approval Should Be Immediately WithdrawnNICOLAS HULSCHER, MPH·AUG 19Read full story |
We used FDA regulatory and clinical-trial data and recalculated the findings using absolute risk differences, numbers needed to vaccinate, numbers needed to harm, risk ratios, and harms incurred per clinical benefit obtained.
The Findings Are Extreme
In the clinical program, unexplained deaths occurred in 23 mFLUSIVA recipients versus 9 conventional flu shot recipients, corresponding to a relative risk (RR) of 2.55 (95% CI, 1.18–5.52). This was statistically significant.
Meanwhile, disabling Grade 3 systemic reactions that prevent daily activity occurred in 5.5% of mFLUSIVA recipients compared with only 0.9% of comparator recipients, corresponding to an RR of 6.15 (95% CI, 4.11–9.20). This was also statistically significant.
When putting benefits and harms on the same scale, we found that it’s a form of human sacrifice to administer mFLUSIVA.
To theoretically prevent ONE flu hospitalization:
2 people suffer unexplained deaths
278 people suffer a disabling Grade 3 reaction
3,798 people suffer an adverse event
Even more concerning, only one autopsy was performed across the clinical program, and it occurred in the comparator arm. The program therefore generated a statistically significant imbalance in deaths of undetermined cause without performing autopsies in the mRNA-1010 recipients needed to investigate that signal.
Moreover, despite influenza mortality being one of the major reasons influenza vaccination is promoted in older adults, no influenza-mortality endpoint was specified, collected, or reported in the mFLUSIVA clinical development program.
Market Removal is Now Required
When we first released this analysis, we immediately transmitted it to federal health officials because we believed the findings warranted urgent regulatory action.
Weeks later, the CDC left mFLUSIVA out of its influenza vaccine recommendations for the 2026–2027 season.
However, mFLUSIVA remains FDA-approved and can still be administered to unsuspecting civilians.
The difference now is that the study challenging the core basis for that approval has passed peer review and entered the published scientific literature.
The FDA’s own clinical data now sit in the peer-reviewed record showing a 155% higher risk of unexplained death, a 515% higher risk of disabling reactions, and an extreme risk-benefit imbalance.
At this point, regulators have no legitimate basis to ignore these horrific data. Thus, market removal of this hazardous product is now required to protect public safety. It would also be advisable to fire all individuals involved in approving mFLUSIVA, as they are clearly incapable of doing their jobs and have put innocent civilians at unnecessary risk of death and injury.
Our peer-reviewed study now provides Secretary Kennedy substantial scientific firepower to fulfill the demands of his supporters:
The evidence has been analyzed, the extreme safety hazards have been documented, and the findings have now been peer-reviewed and published. No excuses remain. mFLUSIVA must be removed from the market.
Epidemiologist and Foundation Administrator, McCullough Foundation
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