GSK plc has announced that the European Commission has authorised Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 50-59 who are at increased risk. Since June 2023, GSK’s RSV vaccine has been approved in Europe for adults aged 60 and over for the prevention of RSV-LRTD4.
· An estimated 20 million adults aged 50-59 in 30 European countries* have a medical condition that increases their risk for RSV disease1-3
· Authorisation helps protect this population for the first time ahead of this RSV season
· This follows approval in US, with other countries anticipated, including Japan later this year
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 conditions5,6. RSV can exacerbate these conditions and lead to pneumonia, hospitalisation or death.6
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.2,3
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.7
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”.
In addition to the US and European approvals, GSK has also filed regulatory submissions to extend the use of this vaccine to adults aged 50-59 at increased risk, including in Japan and other geographies with regulatory decisions undergoing review. Trials evaluating the immunogenicity and safety of the vaccine in adults aged 18-49 at increased risk and immunocompromised adults aged 18 and over are expected to read out in later in 2024.
*estimated from the % of individuals aged 50-59 in France, Italy and Spain with at least one chronic condition3 extrapolated to the EU/EEA population of 50-59 years in 2024.1 The European Commission has the authority to approve medicines for the European Union member states, as well as in the European Economic Area (EEA) countries Iceland, Norway and Liechtenstein.
1. United Nations. World Population Prospects 2024. Available at: https://population.un.org/wpp/ – accessed in August 2024
2. Zimmerman, RK et al., “Prevalence of high-risk indications for influenza vaccine varies by age, race, and income” in Vaccine, 28(39), 6470-6477.3, 2010
3. de Fougerolles, TR. et al, “Public health and economic benefits of seasonal influenza vaccination in risk groups in France, Italy, Spain and the UK: state of play and perspectives” in BMC Public Health, 24(1), 1222, 2024
4. Arexvy | European Medicines Agency (EMA). (n.d.). European Medicines Agency (EMA). Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/arexvy. Accessed August 2024 – accessed in August 2024
5. Branche AR et al., “Incidence of Respiratory Syncytial Virus Infection Among Hospitalized Adults, 2017-2020” in Clinical Infectious Diseases, 74:1004-1011, 2022
6. Centers for Disease Control and Prevention (CDC), RSV in Adults. Available at: https://www.cdc.gov/rsv/older-adults/index.html – accessed in August 2024
7. Ferguson, M. et al., “Noninferior Immunogenicity and Consistent Safety of Respiratory Syncytial Virus Prefusion F Protein Vaccine in Adults 50-59 Years Compared to ≥60 Years of Age” in Clinical Infectious Diseases, ciae364, 2024. Advance online publication. doi.org/10.1093/cid/ciae364
