Moderna (NASDAQ:MRNA) officially moved to challenge the multi-billion-dollar seasonal influenza market today, submitting marketing authorization applications for its investigational vaccine, mRNA-1010, to regulators in the U.S., Europe, Canada, and Australia.
The filings target adults aged 50 and older, a demographic that bore the brunt of a 15-year high in flu-related hospitalizations during the previous season.
The regulatory push is anchored by data from the pivotal Phase 3 P304 efficacy study, which demonstrated that mRNA-1010 outperformed licensed standard-dose vaccines.
The trial, involving over 40,000 participants across 11 countries, showed a relative vaccine efficacy (rVE) of 26.6% in adults 50 and older, with protection rising to 27.4% in those aged 65 and above.
Notably, the vaccine met stringent superiority criteria across multiple strains, including A/H1N1 (29.6% rVE) and B/Victoria (29.1% rVE).
The submission also incorporates results from the P303 study, where mRNA-1010 showcased superior seroconversion rates and geometric mean titers (GMTs) compared to both high-dose and standard-dose alternatives.
If authorized, mRNA-1010 would serve as a cornerstone for Moderna’s respiratory portfolio, which also includes its next-generation COVID-19 and combination vaccine candidates.