FDA panel backs first mRNA flu shot for older adults
An FDA advisory panel unanimously recommended approving Moderna’s mFlusiva, the first influenza vaccine made with mRNA technology, for adults ages 50–64 and 65+ pending final FDA clearance by early August. The shot could enable faster manufacturing and better matching to circulating strains. In trials, it reduced flu cases by about 27% in people 50+ versus a standard vaccine and produced a strong immune response in 65+ compared with a high-dose vaccine, with mostly mild, temporary reactions. If approved, Moderna will run a large follow-up study (about 400,000 people 65+) over two seasons to gather more safety and efficacy data, including in frail or immunocompromised individuals.