Vaccines: EU approves anti-RSV indication also for 50-59 year olds at higher risk

The European Commission (EC) has authorized Arexvy – a recombinant adjuvanted vaccine against respiratory syncytial virus (RSV) – for active immunization in the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults at increased risk, aged 50 to 59 years. This expands the indication of the GSK anti-RSV vaccine which – explains a note – was approved in Europe in June 2023 for adults aged 60 years and over, again for the prevention of RSV-LRTD.

Adults with underlying medical conditions such as chronic obstructive pulmonary disease (COPD), asthma, heart failure and diabetes are at increased risk of serious consequences from RSV infection. The virus can exacerbate these conditions and lead to pneumonia, hospitalisation or death. An estimated 65 million adults aged 50 to 59 in the EU and the European Economic Area (EEA) live in the EU and EEA. Of these, around 20 million (one third) have at least one underlying medical condition that puts them at increased risk of RSV disease. “Today’s approval reflects the importance of extending the benefits of RSV immunisation to adults aged 50 to 59 years who are at greatest risk,” said Tony Wood, Chief Scientific Officer, GSK. “RSV infection can have a significant impact on the health of older people and particularly those with certain pre-existing medical conditions, which can place increased pressure on healthcare systems. As we enter the RSV season, we are delighted to be the first to provide a vaccine to help protect more people in Europe from RSV-LRTD.”

The application was supported by positive results from a Phase III study evaluating the immune response and safety of GSK’s RSV vaccine in adults aged 50 to 59 years, including those at increased risk of RSV-LRTD due to certain underlying medical conditions.

“There are many patients in the 50-59 age group living with certain underlying medical conditions and at increased risk of severe RSV infection,” notes Tino F. Schwarz, Professor, Klinikum Würzburg Mitte, Würzburg, Germany. “These patients will likely benefit from the extension of the RSV vaccine age indication, helping to reduce the disease burden of associated LRTDs. I hope that the NITAGs (National Immunization Technical Advisory Groups, ed.) in Europe will quickly adapt the RSV vaccination indication to include these patients.”

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Following approvals in the United States and Europe, GSK expects, by the end of the year, authorization to extend the use of this vaccine to adults aged 50 to 59 years at increased risk of disease, including from regulatory agencies in Japan and other geographic areas. Also by December 2024, the publication of ongoing studies evaluating the immunogenicity and safety of the vaccine in adults aged 18 to 49 years at increased risk and in immunocompromised adults aged 18 years and older is expected.