Particle.news
Download on the App Store
44 ARTICLES
·
last wk.

FDA Clears Moderna’s mFlusiva as First mRNA Seasonal Flu Vaccine for Adults 50 and Older

The approval creates a faster way to update seasonal and pandemic flu shots pending CDC advisory guidance and vaccine procurement schedules.

Moderna's mRNA-based flu vaccine, mFLUSIVA, is seen in an image provided by the company on Thursday, Aug. 6, 2026. The FDA granted approval a day earlier for the vaccine’s use in all adults 50 and older. (Courtesy of Moderna)
FILE - The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, April 22, 2025. (AP Photo/Jose Luis Magana, File)
gloved hands draw fluid from a vaccine vial into a syringe

Overview

  • The FDA approved Moderna’s mFlusiva on Wednesday, granting full approval for adults 50–64 and accelerated approval for adults 65 and older with a required post‑licensure confirmatory study.
  • Regulators based the decision on Phase 3 data from more than 40,000 adults that showed roughly a 26.6–27% improvement in preventing lab‑confirmed flu versus a standard‑dose comparator.
  • Trial participants receiving mFlusiva reported higher rates of short‑lived side effects such as injection‑site pain, fatigue and headache, and investigators recorded a small number of serious events judged related to the vaccine.
  • The review was unusually contentious: the FDA initially refused to file the application over the comparator choice, reversed that decision after public pushback, saw leadership changes, and then received a unanimous advisory‑panel endorsement in June.
  • The mRNA platform’s faster design and manufacturing could improve strain matching and speed pandemic response, but near‑term uptake may be limited because the CDC advisory panel cannot meet under its current membership and Moderna missed the primary 2026 contracting cycle.