Overview
- FDA staff reviewers released briefing documents on June 16 saying Moderna’s mFlusiva filing had no “major deficiencies” and raised no serious efficacy or safety objections for adults 50 and older.
- The Vaccines and Related Biological Products Advisory Committee will vote on June 18 on whether the vaccine’s benefits outweigh its risks for people 50 and older, and the FDA aims to issue a final decision by August 5.
- Moderna’s trial showed superior vaccine efficacy versus a standard‑dose shot in adults 50–64, while the case for people 65 and older rests on immunogenicity data rather than direct efficacy against the CDC‑preferred high‑dose comparator.
- FDA staff flagged gaps that limit how well results apply to the oldest and most vulnerable patients because trials ran in a single season and excluded immunocompromised and very frail seniors; Moderna has agreed to run confirmatory post‑marketing studies if 65+ is granted accelerated approval.
- Markets reacted to the favorable briefing with about a 9% intraday jump in Moderna shares and the company announced Ester Banque as chief commercial officer as it prepares for possible mRNA flu and combination vaccine launches in 2027–2028.