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Japan MHLW approves Arexvy for adults 18-49 AIR
GSK plc announced that Japan's Ministry of Health, Labour and Welfare has expanded the approval for its RSV vaccine, Arexvy, to include adults aged 18 to 49 years at increased risk, making it the first RSV vaccine approved for all at-risk adults in Japan. The vaccine was previously approved for adults aged 60 and older, and for adults aged 50-59 at increased risk. The prescribing information has also been updated to explicitly include immunocompromised patients as an increased risk group, supported by data from Phase IIIb and Phase IIb trials demonstrating non-inferior immune response and a consistent safety profile. Disclaimer*
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[{"type":"text","content":"\n\n Issued: 18 May 2026, London UK\n \nGSK's RSV vaccine, Arexvy, receives expanded approval in Japan for adults aged 18-59 at increased risk\n \n· First RSV vaccine approved for adults aged 18-59 years at increased risk and for all adults 60 years and older in Japan\n· In Japan, millions of adults live with certain chronic conditions that increase their risk of severe RSV outcomes[1],[2],[3],[4],[5],[6]\n \n \n\nGSK plc (LSE/NYSE: GSK) today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has expanded the eligible population for Arexvy (Respiratory Syncytial Virus vaccine, [adjuvanted, recombinant]), to include adults aged 18 to 49 years at increased risk (AIR) for RSV disease. GSK's RSV vaccine was previously approved in Japan for the prevention of RSV disease in all adults aged 60 years and older, and for adults aged 50-59 AIR for RSV disease. The prescribing information for Arexvy has also been updated to explicitly include immuno-compromised (IC) patients as an increased risk group - helping clinicians to identify people who may benefit from RSV prevention.\n \nSanjay Gurunathan, GSK Head of Vaccines and Infectious Diseases Research and Development, said:\n\"This expanded approval, the first covering all at-risk adults in Japan, can help reduce potentially severe outcomes of RSV. It recognises the serious impact RSV can have for adults of any age living with chronic conditions such as cardiovascular disease, chronic obstructive pulmonary disease and asthma, and it enables more people to take a proactive approach to disease prevention.\"\n \nRSV is a common and contagious respiratory virus that can cause serious illness in adults, particularly those living with certain chronic conditions.6,[7],[8] RSV infection can cause major adverse cardiovascular events (MACE) including heart attack and stroke,4,[9],[10],[11],[12] trigger flare-ups of chronic obstructive pulmonary disease (COPD) and asthma and may result in severe illness, hospitalisation, and even death.6 More than 42 million adults in Japan are aged 18-491 and, while often considered at low risk of RSV, many in this group live with underlying chronic conditions.2\n \nThe approval was supported by data from a Phase IIIb trial (NCT06389487) demonstrating a non-inferior imm...