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byNicolas Hulscher, MPHSomething significant just happened to Moderna’s newly approved mRNA flu shot.Just weeks after we sent ourreanalysis study of the FDA’s mFLUSIVA clinical datadirectly to senior HHS officials, the CDC has now left the dangerous product out of its 2026–2027 influenza vaccine recommendations.Theagency’s websitestates that,“because of legal uncertainties and inquiries,”it is keeping the July 2025 influenza recommendations in effect for the upcoming season rather than updating them.That matters because mFLUSIVA was not approved until August 5, 2026. By freezing the older recommendations, CDC has effectively left Moderna’s new mRNA flu shot outside the current guidance.While this is not a withdrawal of FDA licensure, it still represents aWIN.Our studyreanalyzed the FDA briefing document used to support approval of mFLUSIVA and found an extreme risk-benefit imbalance.For every5,017 people vaccinatedto theoretically “prevent”ONE influenza hospitalization, the trial data showed:2 excess unexplained deaths278 Grade 3 systemic reactions preventing daily activity3,798 recipients experiencing at least one solicited adverse reactionThe unexplained death imbalance was approximately2.5-fold higherin the mFLUSIVA group than in the traditional flu vaccine comparator group.Our conclusion was straightforward: The product’s risk-benefit profile does NOT support continued market authorization.The next step is clear:REVOKE MARKET AUTHORIZATION to prevent unnecessary death and disability to civilians.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.