FDA expands approval of GSK's RSV vaccine to at-risk adults aged 50-59
- FDA approves GSK's RSV vaccine for high-risk adults ages 50 to 59.
- The approval helps GSK to maintain dominance in the RSV market.
- Expanded accessibility for younger patients.
The FDA approved GSK's RSV vaccine for high-risk adults aged 50 to 59, expanding accessibility to younger patients. Arexvy was initially approved for those 60 and older but is now available for the younger age group. The vaccine showed similar immune responses in both age groups, with mild to moderate side effects. Around 13 million Americans aged 50 to 59 are at risk of severe RSV outcomes. GSK is seeking approval to expand the vaccine's age range globally and is studying its application in high-risk adults aged 18 to 49. The vaccine has shown efficacy in preventing severe RSV illness and is expected to generate significant sales. Further trials are planned to assess long-term protection and expand the vaccine's reach to other patient groups.