FDA has approved Moderna’s mRNA influenza vaccine for older adults, marking the first licensed flu shot built using the technology. The decision follows a February “refusal-to-file” that halted review of the initial data package and an eventual reversal after the company disclosed the dispute. The approval comes after the temporary policy friction involved Vinay Prasad, then head of the FDA’s biologics office, who issued the refusal-to-file notice and later stepped down at the end of April. Moderna framed the turnaround as a reversal of the agency’s position, and the latest action clears the product for a defined older-adult population. From an industry standpoint, the regulator’s decision underscores how mRNA platform approvals are continuing to broaden beyond COVID-19. It also sets a reference point for future season-by-season mRNA vaccine filing strategies and evidentiary expectations at FDA.