FDA Approval

FDA Approves mFLUSIVA for Influenza Prevention in Adults Aged 50 Years and Older

Edited by:
Anthony Calabro, MA

Key Highlights

  • The FDA approved mFLUSIVA (mRNA-1010) for active immunization for the prevention of influenza disease caused by influenza A subtypes and influenza B types represented in the vaccine in adults aged 50 years and older.
  • Approval for adults aged 50 through 64 years was supported by a randomized, observer-blind, active-controlled phase 3 trial enrolling 40,805 adults aged 50 years and older across 11 countries.
  • The indication for adults aged 65 years and older received accelerated approval based on immune responses from an active-controlled trial of 2,992 adults, with clinical benefit to be evaluated in a postmarketing confirmatory trial.
  • Reported clinical trial side effects included injection-site reactions, fatigue, headache, muscle pain, joint pain, chills, nausea or vomiting, and fever.

On August 5, 2026, the FDA approved mRNA-1010 (mFLUSIVA, Moderna Inc.) for use in adults aged 50 years and older. The mRNA-based influenza vaccine is indicated for active immunization to prevent influenza disease caused by influenza A subtypes and influenza B types represented in the vaccine. For adults aged 65 years and older, the indication was granted under the accelerated approval pathway based on immune responses. Continued approval in this population may be contingent on verification and description of clinical benefit in a confirmatory trial.

Approval in adults aged 50 through 64 years was based on a randomized, observer-blind, active-controlled phase 3 trial (NCT06602024) that enrolled 40,805 adults aged 50 years and older across 11 countries. The study evaluated safety and reactogenicity and relative vaccine efficacy compared with a standard-dose active comparator against reverse transcription polymerase chain reaction–confirmed, protocol-defined influenza-like illness caused by influenza A or B strains.

Accelerated approval in adults aged 65 years and older was based on a randomized, observer-blind, active-controlled trial (NCT05827978) involving 2,992 US adults aged 65 years and older. The primary objective was to assess immunogenicity compared with a high-dose inactivated influenza vaccine. Effectiveness in this population was also supported by a descriptive analysis of relative vaccine efficacy from NCT06602024. Confirmation of clinical benefit will be assessed in a postmarketing clinical trial.

Reported clinical trial side effects included injection-site pain, tenderness, swelling or hardness, redness, and swelling of lymph nodes in the same arm as the injection, as well as fatigue, headache, muscle pain, joint pain, chills, nausea or vomiting, and fever. Severe allergic reactions are rare but can occur after vaccination and, if they occur, usually develop within minutes to 1 hour after a dose.

Reference
Moderna, Inc. Moderna receives U.S. FDA approval for influenza vaccine mFLUSIVA. Published August 5, 2026. Accessed August 7, 2026. https://feeds.issuerdirect.com/news-release.html?newsid=4801915282452025&symbol=MRNA