MRNA FDA decision: Aug 5, 2026

MFLUSIVA (Influenza Vaccine, mRNA / mRNA-1010) was approved by the FDA on August 5, 2026 for seasonal influenza in U.S. adults 50 years of age and older.

Verified against: FDA action day August 5, 2026 (CBER approval letter) · Announcement August 5, 2026 (sponsor announcement) · Goal date August 5, 2026 (Moderna 8-K).

MFLUSIVA (Influenza Vaccine, mRNA), the first mRNA influenza vaccine licensed in the United States, approved for active immunisation against influenza A and B in people 50 years and older (Aug 5 2026).

Run-up into the decision (T-120 → T+5)

Key facts

Approved on the August 5, 2026 goal date. The approval is split: traditional approval for the 50 and over population, with the indication for people 65 and older granted under accelerated approval, carrying a required post-marketing study comparing relative vaccine efficacy against a high-dose influenza vaccine in US adults 65 and over, due to complete in 2029. This application had previously received a Refusal to File letter on February 3, 2026, which the FDA based solely on the choice of a standard-dose comparator rather than on safety or efficacy; the amended application was accepted two weeks later. An advisory committee voted 9 to 0 in favour for both age groups on June 18, 2026.

Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.

Primary source: FDA CBER product page and approval letter, August 5, 2026

FDA record of the action: the FDA approved on August 5, 2026, per CBER approval letter (MFLUSIVA, BLA 125869) (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.