MRNA · News · 20260805N

Regulatory Approval Milestones

Moderna, Inc. · 2026-08-05 · Importance 44 · Surprise 60 · In source text

The U.S. Food and Drug Administration approved Moderna’s mFLUSIVA (mRNA-1010), the first mRNA-based seasonal influenza vaccine. It is authorized for adults aged 50 and older, with traditional approval for ages 50–64 and accelerated approval for those aged 65 and above. Moderna expects initial supply at select retailers for the 2026–2027 respiratory virus season. The approval follows an FDA refusal-to-file letter in February 2026 that was later rescinded, highlighting regulatory execution risk but creating a potential commercial growth platform beyond COVID-19 vaccines.

Key facts

• mFLUSIVA (mRNA-1010) has been approved by the U.S. Food and Drug Administration for use in all adults 50 years and older. source
• Moderna expects supply of mFLUSIVA to be available in select retailers in the coming weeks. source
• The shot is approved with traditional approval for ages 50-64 and accelerated approval for those 65 and older. source
• mFLUSIVA becomes Moderna's fifth approved product globally and fourth FDA-approved product. source
• The FDA approval follows unanimous recommendations from the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) supporting mFLUSIVA for adults 50 years of age and older. source

Impact estimates