GSK gets Japan’s approval for RSV vaccine for older adults

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

Arexvy’s approval will help protect adults 60 years of age and older in Japan from RSV disease for the first time, including those living with underlying medical conditions who are most at risk of severe RSV disease.

RSV causes an estimated 63,000 hospitalisations and 4,500 in-hospital deaths in adults 60 years of age and older in Japan each year. The approval – the first in Asia – is based on a comprehensive phase III programme, which enrolled over 1,000 Japanese participants.

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.

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”.

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.

About AReSVi-006

This is a randomised, placebo-controlled, observer-blind, multi-country phase III trial to demonstrate the efficacy of a single dose of GSK’s adjuvanted RSVPreF3 vaccine in adults aged 60 years and above. Approximately 25,000 participants were enrolled from 17 countries. Initial results were published in the New England Journal of Medicine in February 2023.

About respiratory syncytial virus (RSV) in adults

 RSV is a common contagious virus affecting the lungs and breathing passages. Older adults are at high risk for severe disease. RSV can exacerbate conditions, including chronic obstructive pulmonary disease (COPD), asthma and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalisation, and death. Each year, RSV causes over 470,000 hospitalisations and 33,000 in-hospital deaths in adults 60 years of age and older in industrialised countries, including approximately 63,000 hospitalisations and 4,500 deaths in Japan. Adults with underlying conditions are more likely to seek medical advice and have higher hospitalisation rates than adults without these conditions.