Business
EU authorisation of GSK’s RSV vaccine Arexvy
EU authorisation of GSK’s RSV vaccine Arexvy.
About this update from Gsk Plc
[{"type":"text","content":"\n\nIssued: 7 June 2023, London UK\n \nEuropean Commission authorises GSK's Arexvy, the first respiratory syncytial virus (RSV) vaccine for older adults\n \n· Authorisation will help protect adults 60 years of age and older in 30 European countries* from RSV disease for the first time\n· In Europe, RSV leads to over 270,000 hospitalisations and approximately 20,000 in-hospital deaths in adults 60 years of age and older each year\n· The authorisation is based on phase III efficacy data in older adults\n \nGSK plc (LSE/NYSE: GSK) today announced that the European Commission has authorised Arexvy (respiratory syncytial virus vaccine, adjuvanted) for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. This is the first time an RSV vaccine for older adults has been granted European Marketing Authorisation. The first launches are planned ahead of the 2023/2024 RSV season which typically starts in the autumn.\n \nTony Wood, Chief Scientific Officer, GSK, said: \"Thousands of older adults across Europe suffer serious respiratory illness due to RSV each year. This authorisation for Arexvy means eligible adults can be vaccinated against RSV disease for the first time, reinforcing GSK's long history of vaccine innovation. Our strong manufacturing capability and scale, including from our vaccine manufacturing site in Belgium, means we are ready to deliver the vaccine as countries begin to launch.\"\n \nRSV is a common, contagious respiratory virus that leads to over 270,000 hospitalisations and approximately 20,000 in-hospital deaths each year in adults aged 60 years and over in Europe1. An estimated 3 million cases of RSV acute respiratory infection (ARI) are reported in this population each year, and the impact on healthcare systems is expected to increase as the population ages1. Those with underlying medical conditions, such as diabetes and chronic heart and lung disease, drive the majority of RSV hospitalisations.2,3\n \nDr Alberto Papi, Full Professor of Respiratory Medicine and Head at the University of Ferrara, said: \"For most, RSV causes cold-like symptoms. For older adults and those with underlying medical conditions however, it can lead to severe disease a...