European Commission approves expanded age indication for Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted), the first respiratory syncytial virus (RSV) vaccine for adults aged 50-59 at increased risk.- GSK

Since June 2023, GSK’s RSV vaccine has been approved in Europe for adults aged 60 and over 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 for severe consequences from an RSV infection compared to those without these conditions. RSV can exacerbate these conditions and lead to pneumonia, hospitalisation or death. It is estimated that there are about 65 million adults aged between 50 and 59 in the European Union/European Economic Area1, with an estimated 20 million of these people (one-third) having at least one underlying medical condition that puts them at increased risk for RSV disease.

Tony Wood, Chief Scientific Officer, GSK, said: “Today's approval reflects the importance of broadening the benefits of RSV immunisation to adults aged 50-59 who are at increased risk. RSV infection can have a significant impact on the health of older adults and particularly those with certain existing medical conditions, which can add pressure onto healthcare systems. As we enter the RSV season, we are pleased to be the first to deliver a vaccine to help protect more people in Europe from RSV-LRTD.”

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

Prof. Dr. Tino F. Schwarz, Klinikum Würzburg Mitte, Würzburg, Germany said: "There are a great number of patients in the age-group 50-59 years living with certain underlying medical conditions with an increased risk for severe RSV infection. These patients are likely to benefit from the extension of the age indication of the RSV vaccine, helping to reduce the burden of disease of RSV associated LRTDs. I hope that the NITAGs in Europe will rapidly adapt the indication of RSV vaccination to include these patients".