Japan’s Ministry of Health, Labour and Welfare accepts Arexvy (RSV vaccine) regulatory application to prevent RSV disease in adults aged 50-59 at increased risk

GSK

12 December 2023 - Submission supported by positive results of a Phase 3 study showing immune response and safety in adults aged 50-59.

GSK today announced that Japan’s Ministry of Health, Labour and Welfare has accepted for review a regulatory application to extend the indication of GSK’s respiratory syncytial virus vaccine (recombinant adjuvanted) for the prevention of RSV disease in adults aged 50-59 at increased risk.

Read GSK press release

Michael Wonder

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Michael Wonder

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Vaccine , Dossier , Japan