Shots:
- The US FDA has approved Arexvy RSV vaccine for adults (18-49yrs.) at increased risk for lower respiratory tract disease, expanding its use beyond those aged ≥50yrs.
- Approval was based on P-IIIb trial (n=1458) assessing immune response & safety of Arexvy RSV vaccine in individuals (18-49yrs.; n=426) compared to adults (≥60yrs.; n=429); an additional cohort (18-49yrs.; n=603) was followed for AEs separate to safety follow-up of the initial cohort
- Trial showed non-inferior immune response in individuals (18-49yrs.) who are at increased risk of RSV-LRTD compared to adults (≥60yrs.). Vaccine efficacy was demonstrated in the earlier P-III study
Ref: GSK | Image: GSK | Press Release
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