FDA Approves Moderna's RSV Vaccine mRESVIA for Seniors

May 31, 2024, 03:34 PM

The U.S. Food and Drug Administration (FDA) has approved Moderna's respiratory syncytial virus (RSV) vaccine, mRESVIA, for adults aged 60 and older. This approval marks Moderna's second licensed product and the first mRNA-based vaccine for a disease other than Covid-19. The vaccine, which is available in single-dose prefilled syringes, aims to protect older adults against RSV, a significant respiratory threat that causes between 6,000 and 10,000 deaths among seniors annually. The approval is expected to provide Moderna with much-needed new revenue. The Centers for Disease Control and Prevention (CDC) will meet next month to make formal vaccine recommendations for the 2024-25 RSV season. Moderna's mRESVIA joins RSV vaccines from GSK and Pfizer, which were approved last year. The vaccine's label includes lower-than-expected efficacy.