By IDSE News Staff
The FDA granted a new indication for GSK’s Arexvy adjuvanted respiratory syncytial virus vaccine to prevent RSV-related lower respiratory tract disease (LRTD) in adults 50 through 59 years of age who are at increased risk for RSV.
The RSV vaccine contains recombinant RSV glycoprotein F stabilized in the pre-fusion conformation (RSVPreF3).
The agency reviewed positive results from a phase 3 trial (ClinicalTrials.gov Identifier: NCT05590403) evaluating the immune