The FDA approved Moderna’s mRNA influenza vaccine mFLUSIVA (mRNA-1010), making it the first mRNA-based seasonal flu shot cleared in the U.S. Regulators previously declined to review the submission before reversing course after additional data. The label covers adults in two age brackets, including an accelerated approval framework for adults 65 and older that depends on results from a required postmarketing study. Moderna positioned the decision as a validation of its broader mRNA platform for faster updates to circulating viral strains. The approval follows the same regulatory pattern that helped Moderna’s COVID-19 vaccines reach market earlier, but it also came amid public and policy controversy around mRNA research support and FDA review timing.