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byNicolas Hulscher, MPHIn a dark day for MAHA, the FDA has approved Moderna’s mFLUSIVA for adults 50 and older, making it the first seasonal mRNA influenza injection authorized in the United States. Adults ages 50–64 received traditional approval, while adults 65 and older received accelerated approval based largely on antibody responses.TheFDA’s own briefing documentreveals that75.3% of senior mRNA-vaccine recipients experienced at least one solicited adverse reaction within seven days, compared with 49.3% of those receiving Fluzone High-Dose.Even more concerning,severe (Grade 3) systemic reactions occurred in 6.7% of mRNA recipients versus 1.7% with the traditional high-dose flu vaccine—nearly four times as frequently.Even worse, the pivotal efficacy trial containedno placebo group. Instead, Moderna compared mFLUSIVA against traditional flu vaccines.A novel mRNA injection produced adverse reactions in three out of four recipients, induced severe systemic reactions nearly four times as often as the traditional high-dose vaccine, lacked a placebo-controlled pivotal efficacy trial, and the FDA approved it anyway.Our regulatory agencies remain CAPTURED.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.