Shots:
- The US FDA has accepted application of Arexvy RSV vaccine for adults aged 18-49yrs. at increased risk, expanding its use beyond those aged ≥50yrs.; FDA decision is anticipated H1’26. GSK is also seeking expanded RSV vaccine indications in other regions, incl. the EEA & Japan
- Submission 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 immunogenicity in individuals (18-49yrs.) who are at increased risk of RSV-LRTD. Safety & reactogenicity aligned with P-III study data that supported initial approval
Ref: GSK | Image: GSK | Press Release
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