Priority Reviews are granted by the FDA in response to applications for vaccines that, if approved, have the potential to offer significant improvements in the safety or effectiveness of the treatment or prevention of critical conditions when compared to standard applications. The FDA’s action date for its regulatory decision is scheduled for 3 May 2023.
With the FDA’s approval, GSK’s RSV older adult vaccine candidate could have the potential to be a first-of-its-kind vaccine available for the protection of adults aged 60 years and older from lower respiratory tract disease (LRTD) as a result of RSV.
