FDA advisers back Moderna flu shot for adults 50 and older
What's next: The FDA is expected to decide by Aug. 5 on what could become the first mRNA-based seasonal flu vaccine.
FDA vaccine advisers voted unanimously on June 18 to support approval of Moderna’s seasonal flu shot for adults 50 and older, boosting the company’s bid to launch the first mRNA-based influenza vaccine in the United States. The panel backed use of mFlusiva for adults 50 to 64 and for those 65 and older, even as the older group had faced extra regulatory scrutiny. Moderna told advisers its shot beat standard-dose flu vaccines in adults 50 to 64, while a smaller study found a strong immune response against a high-dose comparator in older adults. The decision also serves as an early test of FDA vaccine review practices after leadership turnover and recent clashes over vaccine approvals.