The FDA has approved mFLUSIVA (mRNA-1010), the first mRNA-based seasonal influenza vaccine, for adults aged 50 years and older. Moderna received traditional approval for adults aged 50–64 years and accelerated approval for those aged 65 years and older, with a postmarketing study planned to confirm effectiveness in the older population. We are grateful to the clinical trial participants, investigators, regulators and Moderna teams whose contributions made this milestone possible." The FDA's approval of mFLUSIVA in adults 50 through 64 years of age is based on results from a randomized, observer-blind, active-controlled, Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT06602024), which enrolled 40,805 adults aged 50 years and older across 11 countries. Confirmation of clinical benefit in this population will be assessed in a postmarketing clinical trial.