Moderna Receives FDA Approval for RSV Vaccine

Moderna has announced that the FDA has approved mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. The approval was granted under a breakthrough therapy designation and marks the second approved mRNA product from Moderna which has filed for mRNA-1345 approval with regulators in multiple markets around the world. Moderna expects to have mRESVIA available for eligible populations in the U.S. by the 2024/2025 respiratory virus season.

“The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform,” said Stéphane Bancel, Moderna CEO. “mRESVIA protects older adults from the severe outcomes of RSV infection, and it is the…first time an mRNA vaccine has been approved for a disease other than COVID-19.”

RSV is a highly contagious seasonal respiratory virus and a leading cause of lower respiratory tract infections and pneumonia that causes a particularly large burden of disease in infants and older adults. Each year in the U.S., approximately 60,000-160,000 older adults are hospitalized and 6,000-10,000 die due to RSV infection.

The FDA’s approval of mRESVIA is based on positive data from the Phase 3 clinical trial ConquerRSV, a global study conducted in approximately 37,000 adults ages 60 years or older in 22 countries. The primary analysis with 3.7 months of median follow-up found a vaccine efficacy against RSV lower respiratory tract disease of 83.7% . An additional longer-term analysis showed continued protection against RSV LRTD over 8.6 months median follow-up. (Source: Moderna Website, 31 May, 2024)