Document text
byNicolas Hulscher, MPHOur reanalysis of the FDA clinical data used to approve Moderna’s new mRNA influenza injection (mFLUSIVA) has now beenPEER-REVIEWED and PUBLISHED in theJournal of Independent Medicine.This is the same study wepreviously sent directly to senior officialsat HHS, FDA, CDC, and NIH, calling for immediate reversal of its authorization.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 ExtremeIn the clinical program,unexplained deaths occurred in 23 mFLUSIVA recipients versus 9 conventional flu shot recipients, corresponding to arelative risk (RR) of 2.55 (95% CI, 1.18–5.52). This was statistically significant.Meanwhile, disablingGrade 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 of6.15 (95% CI, 4.11–9.20). This was also statistically significant.When putting benefits and harms on the same scale, we found thatit’s a form of human sacrifice to administer mFLUSIVA.To theoretically prevent ONE flu hospitalization:2 people suffer unexplained deaths278 people suffer a disabling Grade 3 reaction3,798 people suffer an adverse eventEven 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 RequiredWhen we first released this analysis, we immediately transmitted it to federal health officials because we believed the findings warranted urgent regulatory action.Weeks later, theCDC left mFLUSIVA outof 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 thedemands 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.Nicolas Hulscher, MPHEpidemiologist and Foundation Administrator, McCullough FoundationSupport our mission:mcculloughfnd.orgPlease consider following both theMcCullough Foundationandmy personal accountonX(formerly Twitter) for further content.FOCAL POINTS (Courageous Discourse™) is a reader-supported publication. To receive new posts and support my work, consider becoming a paid subscriber.