Europe Processes RSV Vaccine Authorization

GSK plc today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use had adopted a positive opinion by consensus recommending approval of GSK's respiratory syncytial virus (RSV) vaccine candidate for the prevention of lower respiratory tract disease caused by RSV in adults aged 60 years and older.

If approved, AREXVY™ RSV OA candidate has the potential to be the first RSV vaccine available to help protect older adults.

The European Commission's final decision is expected by July 2023.

This is the first time an RSV vaccine candidate for adults has gained a positive opinion, one of the final steps in the marketing authorization procedure before approval by the European Commission.

As of April 27, 2023, no RSV vaccines or specific treatments are currently available for older adults in Europe or the U.S.

RSV is a common contagious virus affecting the lungs and breathing passages. RSV causes over 270,000 hospitalizations and approximately 20,000 in-hospital deaths in adults aged 60 years and older each year in Europe.

However, according to recent information, RSV's intensity may have returned to normal in the U.S.

The U.S. CDC's Morbidity and Mortality Weekly Report, published on April 7, 2023, presented the seasonality of RSV in the U.S. from 2017–2023. 

The CDC reported the 2022–23 RSV season started later than the 2021–22 season but earlier than the prepandemic seasons, suggesting a return toward prepandemic seasonality.

For updated information, the CDC's RSV-NET interactive dashboard displays trends and comparisons of RSV-associated hospitalizations in various demographic groups and seasons.