Moderna Shares Up 9.5% After FDA Staff Review
On Tuesday, 16 June 2026, Moderna Inc shares rose 9.5%, trading above $57 in afternoon trading after U.S. Food and Drug Administration (FDA) staff released positive assessments of the company’s influenza vaccine candidate, mFlusiva. The FDA staff briefing documents highlighted that data show a strong immune response to the flu shot in adults aged 65 years and older, suggesting potential effectiveness in this high‑risk group.
The documents also indicated that mFlusiva demonstrated superior relative vaccine efficacy compared with a standard‑dose influenza vaccine in adults aged 50 to 64 years. The FDA’s advisory committee is scheduled to convene on 18 June 2026 to vote on whether the benefits of mFlusiva outweigh its risks for adults 50 years and older, and to specifically evaluate the benefit‑risk profile for older adults.
FDA staff noted that Moderna’s application for the 65‑plus population relies primarily on immunogenicity data against a standard‑dose vaccine rather than the Centers for Disease Control and Prevention‑preferred high‑dose shots for older adults.
This article was generated with AI assistance and reviewed by an editor.