FDA Grants Priority Review to GSK’s Older Adult RSV Vaccine

The FDA has granted a priority review to GSK’s Biologics License Application (BLA) for its respiratory syncytial virus (RSV) vaccine candidate for older adults.

If approved, the vaccine could be the first available to protect adults age 60 and older from the lower respiratory tract disease which often involves mild cold-like symptoms but can be dangerous for older adults. Currently, there are no approved RSV vaccines for older adults.

The BLA is supported by phase 3 trial data that demonstrated high overall vaccine efficacy against RSV lower respiratory tract disease in adults age 60 years and older.

The FDA action date for this application is May 3, 2023.