FDA approves mRESVIA, Moderna's mRNA RSV vaccine for adults 60 and older

Moderna/Respiratory vaccines

The FDA approved mRESVIA (mRNA-1345), Moderna's mRNA vaccine against respiratory syncytial virus, for adults 60 and older. It was Moderna's second approved product and demonstrated that the mRNA platform could deliver vaccines beyond COVID-19.

• mRESVIA targets RSV lower respiratory tract disease; Phase 3 showed 83.7% efficacy against RSV LRTD with ≥2 symptoms.
• Study enrolled 35,541 adults ≥60; efficacy was 82.4% against disease with ≥3 symptoms.
• Approval after Phase 3 publication in NEJM; safety profile included mild to moderate local/systemic reactions.
• Moderna's first non-COVID mRNA product on market, validating platform for other respiratory viruses.