Moderna Receives U.S. FDA Approval for RSV Vaccine mRESVIA

CAMBRIDGE, MA / May 31, 2024 / Moderna Inc. (NASDAQ:MRNA) announced the U.S. FDA approval of mRESVIA (mRNA-1345), an mRNA-based vaccine for respiratory syncytial virus (RSV) aimed at adults 60 years and older. This approval, under breakthrough therapy designation, marks Moderna's second approved mRNA product.

mRESVIA is the first RSV vaccine available in single-dose pre-filled syringes, designed to ease administration and reduce errors. Stéphane Bancel, Moderna's CEO, highlighted the vaccine's role in protecting older adults from severe RSV outcomes, extending the application of mRNA technology beyond COVID-19.

The approval follows positive Phase 3 trial results from around 37,000 participants in 22 countries, where the vaccine showed 83.7% efficacy against RSV lower respiratory tract disease. Moderna plans to have mRESVIA available in the U.S. by the 2024/2025 respiratory virus season and has sought approval in other markets.