Japan’s Ministry of Health, Labour and Welfare approves GSK’s Arexvy, the country’s first respiratory syncytial virus (RSV) vaccine for older adults

GSK plc announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) for the prevention of RSV (respiratory syncytial virus) disease for adults 60 years of age and above. This is the first time an RSV vaccine for older adults has been approved in Japan.

Tony Wood, Chief Scientific Officer at GSK, said: “Arexvy is Japan’s first approved RSV older adult vaccine, and is a major advance for public health with the potential to help protect around 43.5 million Japanese people aged 60 and older. Following key approvals in the US, EU, UK and Canada earlier this year, today’s authorisation reinforces GSK’s industry-leading vaccine portfolio”.

RSV is a common, contagious respiratory virus that causes an estimated 470,000 hospitalisations and 33,000 deaths each year in adults 60 years of age and older in industrialised countries, including approximately 63,000 hospitalisations and 4,500 deaths in Japan. Its impact on healthcare systems may further increase as the population ages. Those with underlying medical conditions, such as chronic heart disease, chronic lung disease or diabetes, account for the majority of RSV hospitalisations.

The approval has been granted based on data from the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase III vaccine efficacy trial, published in the New England Journal of Medicine. In the trial, the vaccine showed statistically significant and clinically meaningful overall efficacy of 82.6% (96.95% CI, 57.9–94.1, 7 of 12,466 in the Arexvy arm vs 40 of 12,494 in the placebo arm) against RSV-LRTD in adults aged 60 years and older, meeting the primary endpoint. In addition, secondary descriptive endpoints show that efficacy was 94.6% (95% CI, 65.9–99.9, 1 of 4,937 in the Arexvy arm vs 18 of 4,861 in the placebo arm) in older adults with at least one underlying medical condition of interest, such as certain cardiorespiratory and endocrine-metabolic conditions.

The vaccine was generally well tolerated. The most frequently observed solicited adverse events were injection site pain, fatigue, myalgia, headache and arthralgia. These were generally mild to moderate and transient.

This is the fifth major regulatory approval for Arexvy, building on approvals from the US Food and Drug Administration, the European Commission, and the regulatory authorities in the UK and Canada.