The FDA approved Moderna’s mRNA influenza vaccine, mFlusiva (mRNA-1010), marking the first licensed seasonal flu vaccine that uses mRNA technology. Moderna’s approval follows an unusual earlier phase in which the agency refused to review the application before reversing course after a formal reconsideration. The FDA cleared mFlusiva for adults aged 50 to 64 and adults aged 65 and older under conditions that include an accelerated approval framework for the older cohort, tied to postmarketing study requirements. Moderna reported earlier trial results showing improved protection versus standard-dose flu vaccines. Regulators’ decision lands as political and payer conversations around mRNA vaccines remain active, but it provides a concrete regulatory foothold for mRNA manufacturing and rapid strain updates in seasonal immunization.