Overview
- The Vaccines and Related Biological Products Advisory Committee met June 18 to vote on whether Moderna’s mFlusiva (mRNA-1010) delivers more benefit than risk for people 50 and older.
- FDA staff told the panel they found no major deficiencies in Moderna’s filing and reported superior efficacy versus a standard-dose comparator in adults 50–64.
- For adults 65 and older, the application relies largely on immunogenicity data rather than direct efficacy against a high-dose comparator, and Moderna seeks accelerated approval with a postmarketing study commitment.
- Reviewers flagged safety and evidence limits including higher rates of solicited adverse reactions with the mRNA shot, several serious adverse events noted in trials, exclusion of immunocompromised and very frail participants, and that efficacy data come from a single season.
- Investors reacted positively to the briefing documents, Moderna named Ester Banque as chief commercial officer, and the FDA’s final decision is due by August 5 with wider implications for manufacturing speed and Moderna’s respiratory vaccine pipeline.