The FDA and Moderna appear aligned as the agency heads into its June 18 Vaccines and Related Biological Products Advisory Committee meeting for the seasonal mRNA-1010 shot, now marketed as mFLUSIVA. The development comes after the FDA issued a February refusal-to-file letter, citing shortcomings in the evidence base, including the lack of a high-dose comparator in older adults. Documents for the adcomm now indicate the regulator has softened its stance. Moderna is seeking full approval for adults ages 50–64 and accelerated approval for adults 65 and older, with a post-marketing study required for full approval. FDA documentation also flags residual evidence uncertainties, including that the dataset is drawn from a single flu season. Jefferies framed the shift as an improvement in the regulator’s posture, highlighting that the FDA saw no major safety concerns or imbalances versus placebo. The FDA further stated that mRNA-1010 “met all prespecified sequential success criteria,” while still requesting focused review of certain gaps ahead of the advisory vote.