FDA Approves Breakthrough RSV Vaccine for Adults > 60

On May 3rd, 2023, a U.S. Food and Drug Administration (FDA) press announcement introduced the first FDA-approved respiratory syncytial virus (RSV) vaccine. RSV, a seasonal virus particularly dangerous for adults with preexisting chronic health conditions, is estimated to cause more than 50,000 hospitalizations and 5,000 deaths each year.

The vaccine, called Arexvy, is approved for the prevention of RSV-related lower respiratory tract disease (LRTD) in adults over age 60. Although the vaccine’s side effects are still being researched due to very rare serious adverse events seen in trials, FDA’s Center for Biologics Evaluation and Research calls Arexvy’s approval “an important public health achievement.”

GSK plc., the vaccine’s manufacturer, plans to launch Arexvy ahead of the next RSV season. Arexvy will be the world’s first successful RSV vaccine.

To learn more about RSV, visit: https://www.cdc.gov/rsv/index.html. To learn more about Arexvy, visit: https://www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine and https://www.gsk.com/en-gb/media/press-releases/us-fda-approves-gsk-s-arexvy-the-world-s-first-respiratory-syncytial-virus-rsv-vaccine-for-older-adults/.