FDA approves Moderna’s mRNA flu vaccine Mflusiva for adults 50+
The U.S. Food and Drug Administration granted approval on Aug. 5, 2026 to Moderna’s mRNA‑based influenza vaccine, Mflusiva, for people aged 50 and older. In a trial of about 40,800 participants the shot cut the risk of lab‑confirmed flu by roughly 27 % compared with a standard‑dose vaccine, but about three‑quarters of recipients reported short‑term reactions versus less than half with the traditional shot. Medicare Part B will cover a single dose each season, and the product is under review by Health Canada for future Canadian rollout.
Why it matters
The approval adds a new revenue stream for Moderna and may drive sales growth as Medicare coverage removes cost barriers for seniors. Health‑Canada review could open a second market later this year, expanding the vaccine’s commercial potential.
Key facts
- 1The FDA approved Mflusiva on Aug. 5, 2026 for adults 50 years and older. cronista.com
- 2In a trial of about 40,800 adults 50 and older, the vaccine lowered lab‑confirmed flu risk by 26.6 % versus a standard‑dose shot. cronista.com
- 3Within a week of vaccination, 76 % of Mflusiva recipients reported reactions, compared with 47 % of those receiving the standard vaccine. cronista.com
- 4Medicare Part B will cover one flu shot each season at no cost to beneficiaries when the provider accepts assignment. cronista.com
- 5Health Canada is reviewing the vaccine, with a decision expected sometime in 2026. barrietoday.com
- 6A May 2026 trial of more than 40,000 participants aged 50 and older showed a 27 % higher effectiveness for the mRNA vaccine versus the traditional flu vaccine. barrietoday.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.