Seasonal flu vaccine (mFLUSIVA, mRNA-1010)
FDA approved for adults 50 and older in August 2026; retail availability is expected in the coming weeks.
What it is
mFLUSIVA is Moderna's mRNA seasonal influenza vaccine. The FDA approved it for all adults 50 and older. Adults 50 to 64 received standard approval, and adults 65 and older received accelerated approval that requires a confirmatory study. Coverage decisions depend on a CDC advisory committee recommendation, which has not met this year because of litigation.
Why it matters to the stock. It is the first mRNA flu vaccine approved in the US. Its launch is the company's main near-term product test for the 2026-2027 respiratory season, and the 2026 revenue target depends in part on it.
News
FDA approves Moderna's mFLUSIVA, the first US mRNA flu vaccine, for adults 50 and older
The FDA approved mFLUSIVA (mRNA-1010), Moderna's seasonal flu vaccine, for adults 50 and older.
FDA advisory committee votes 9-0 for Moderna's mRNA flu vaccine in both age groups
The FDA's vaccine advisory committee voted 9-0 that the benefits of mRNA-1010 outweigh its risks for adults 50 to 64, and also voted 9-0 for adults 65 and older.
FDA reverses course and accepts Moderna's mRNA flu vaccine filing with an August 5 decision date
After a Type A meeting, Moderna proposed splitting the request by age: full approval for adults 50 to 64 and accelerated approval for adults 65 and older, with a post-marketing study.
FDA refuses to file Moderna's mRNA flu vaccine application over its comparator choice
The FDA's vaccine center issued a refusal-to-file letter for mRNA-1010, Moderna's seasonal flu vaccine, even though Moderna had used a priority review voucher.