MRNA · News · 20260819N

Regulatory Approval Milestones

Moderna, Inc. · 2026-08-19 · Importance 71 · Surprise 60

The FDA approved Moderna’s mFlusiva, the first mRNA flu vaccine in the United States for adults aged 50 and older. The approval opens a new seasonal influenza market and expands Moderna’s commercial portfolio beyond COVID-19 vaccines. Analysts expect limited near-term revenue because the vaccine missed annual contracting cycles, but project potential annual sales of approximately $1.1 billion by 2027. Commercial adoption may be challenged by skepticism toward mRNA technology, annual strain-selection timing, and the need for broader international regulatory acceptance.

Key facts

• Moderna and Merck plan to present the full Phase 3 melanoma trial data and engage with regulators for potential approval filings. source