RSV Vaccine Coming to Younger Adults

When the U.S. government approved the first two respiratory syncytial virus (RSV) vaccines in 2023, the indication was for people 60 years and older to prevent lower respiratory tract disease (LRTD) caused by RSV.

Based on recent filings, it appears adults 50 years and older may have access to these important vaccines in time for the next RSV season.

Increasing access to RSV vaccines is viewed as a global public health goal. As of early February 2024, the percentage of U.S. adults age 60+ who report receiving an RSV vaccine this season is 20.8%.

GSK plc announced on February 6, 2024, that the U.S. Food and Drug Administration (FDA) has accepted under Priority Review an application to extend the indication of AREXVY™ adjuvanted RSV vaccine to adults aged 50-59 who are at increased risk for RSV disease.

The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is June 7, 2024.

Previously, on December 12, 2023, Japan's Ministry of Health, Labour, and Welfare accepted a similar application for AREXVY.

If approved, AREXVY would be the first RSV vaccine available to help protect this population during the 2024-2025 RSV season.

As of February 2024, RSV activity was stable or decreased in North America, and most European reporting countries reported the World Health Organization Influenza Update N° 462.

In the U.S., the Centers for Disease Control and Prevention's RSV detection graphs display the 5-week moving average, recently indicating decreased cases in certain states.