The FDA changed its mind and agreed to review Moderna's application for the new flu vaccine mRNA-1010 for adults 50 and older.[1][2] Earlier this month, the agency rejected the application due to a dispute over the design of a clinical trial where the comparator vaccine did not reflect the best available standard of care.[1][3] Moderna proposed an age-based regulatory pathway: full approval for adults 50–64 through a standard procedure and accelerated approval for adults over 65 with a requirement to conduct a post-approval study.[1][2] The FDA accepted the amended Biologics License Application (BLA) and set a target review date of August 5, 2026.[2] The vaccine was tested in two phase 3 studies with 43,808 participants who met all pre-defined primary endpoints.[4] Once approved, mRNA-1010 could be available for adults 50 and older for the 2026/2027 flu season.[2] The application has also been accepted for review in the US, EU, Canada and Australia, with planned filings in additional countries in 2026.[2][5]