On May 31, 2024, Moderna announced that the U.S. Food and Drug Administration (FDA) had 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 FDA’s approval of mRESVIA was 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.

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.