The FDA has approved Moderna’s mRNA seasonal flu vaccine, mFlusiva, marking the first U.S.-licensed flu shot built on mRNA technology. The clearance covers adults aged 50–65 and adults 65 and older, with additional evidence required for the older group under an accelerated pathway. Earlier in the year, the review process became contentious after the FDA declined to move forward with Moderna’s initial application before reversing course shortly afterward. Moderna’s underlying data, according to trial disclosures, showed mFlusiva reduced the likelihood of influenza-like illness by about 27% versus standard-dose flu vaccination in adults 50 and older. Moderna’s win extends a regulatory and commercial push for rapid-response vaccine platforms, while also adding a new product pathway as the company continues to look for growth beyond COVID-19 as sales have declined since the pandemic peak.