Summary by Moomoo AI
Japan's Ministry of Health, Labour and Welfare has approved GSK's Arexvy vaccine for adults aged 50-59 at increased risk of severe RSV disease, expanding its previous approval for those 60 and older. This makes Japan the 35th country to approve the vaccine for this at-risk population group, joining markets including the US.The approval was supported by global phase III trial results demonstrating non-inferior immunogenicity in adults aged 50-59 at increased risk compared to those 60 and older. The safety profile remained consistent with earlier findings in older adults. RSV affects an estimated 64 million people globally annually and can lead to severe outcomes like pneumonia and hospitalization, particularly in those with underlying conditions.The vaccine contains recombinant RSV glycoprotein F with GSK's AS01E adjuvant system. This expansion reflects GSK's commitment to protecting vulnerable populations from RSV disease, which can exacerbate conditions including COPD, asthma, and chronic heart failure.
