Moderna RSV Vaccine Approved by FDA

FDA has approved a Moderna BLA for mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine for adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.

Approval was based on data from the Phase 3 clinical trial ConquerRSV, a global study conducted in about 37,000 adults aged 60 years and older. “The primary analysis with 3.7 months of median follow-up found a vaccine efficacy against RSV lower respiratory tract disease (LRTD) of 83.7% (95.88% CI 66.0%, 92.2%),” Moderna says.

Regarding safety, the company says no serious safety concerns were identified in the trial. The most commonly reported adverse reactions were injection site pain, fatigue, headache, myalgia and arthralgia.

The vaccine is expected to be available for eligible populations in the U.S. by the 2024/2025 respiratory virus season.