mRESVIA Approved to Prevent Respiratory Syncytial Virus for Older Adults

On May 31, 2024, the U.S. Food and Drug Administration (FDA) approved mRESVIA^® (respiratory syncytial virus vaccine – Moderna). It’s a vaccine to help prevent lower respiratory tract disease (LRTD) in patients at least 60 years old. While highly contagious, respiratory syncytial virus (RSV) usually has only mild-to-moderate symptoms, such as coughing, fatigue, fever, runny nose, and sneezing. If it worsens, a pronounced wheeze may differentiate it from flu and other respiratory infections. RSV can be quite serious and even life-threatening for senior adults and those who have chronic diseases, particularly lung disorders. The Centers for Disease Control and Prevention (CDC) reports that as many as 160,000 U.S. patients aged 65 years or older are hospitalized for RSV each year, and up to 10,000 die. In a clinical trial that included over 37,000 participants, mRESVIA was 83% effective against lower respiratory tract disease caused by RSV, compared to a placebo. The recommended dose is one injection (0.5mL) administered intramuscularly (IM). The launch is expected by the 2024/2025 respiratory virus season, but pricing is not yet known. This is the third RSV vaccine approved for use on the U.S. market. Both GSK’s Arexvy and Pfizer’s Abrysvo^® were approved in May 2023 for the same indication as mRESVIA. Abrysvo also received approval for vaccinating women who are in late pregnancy to help protect newborns from LRTD caused by RSV during the first six months of life. Look here for prescribing information.