GSK plc (LON/NYSE: GSK) has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has accepted for review a regulatory application to extend the indication of GSK’s respiratory syncytial virus (RSV) vaccine (recombinant adjuvanted) for the prevention of RSV disease in adults aged 50-59 at increased risk.
· Submission supported by positive results of a Phase III study showing immune response and safety in adults aged 50-59
· Adults aged 50 and above with certain underlying medical conditions are at increased risk for RSV disease
· GSK is the first company to seek regulatory approval to extend RSV vaccination to this population
This regulatory submission follows Japan’s approval of GSK’s vaccine for the prevention of RSV disease in adults from the age of 60 years, and the recent announcement of the positive results (https://www.gsk.com/en-gb/media/press-releases/new-data-for-arexvy-show-potential-to-help-protect-adults-aged-50-to-59/) of a phase III trial [NCT05590403 https://clinicaltrials.gov/study/NCT05590403] evaluating the immune response and safety of GSK’s RSV vaccine in adults aged 50-59, including those at increased risk for RSV lower respiratory tract disease (LRTD) due to certain underlying medical conditions.
The burden of RSV disease in adults is likely to be underestimated due to lack of awareness and standardised testing, as well as under-detection within surveillance studies[1], but people with underlying medical conditions – such as chronic obstructive pulmonary disease (COPD), asthma, chronic heart failure[2] and diabetes[3]– are at increased risk for RSV disease. RSV can exacerbate these conditions and lead to pneumonia, hospitalisation, or death.[4] An international systematic review of the prevalence of respiratory viruses in patients with acute exacerbations of COPD, for example, showed that RSV was detected 1 in 10 cases.[5]
GSK is the first company to seek regulatory approval to extend RSV vaccination to help protect adults aged 50 to 59 at increased risk for RSV disease. Further announcements on regulatory progress in the US and EU are expected in early 2024.
[1] Savic M, Penders Y, Shi T, Branche A, Pirçon J-Y. Respiratory syncytial virus disease burden in adults aged 60 years and older in high-income countries: a systematic literature review and meta-analysis, Influenza Other Respir Viruses 2022 2023; 17:e13031
[2] Falsey, AR et al. Respiratory syncytial virus infection in elderly and high-risk adults, in New Engl J Med 2005; 352:1749-59
[3] Richard Osei-Yeboah et al, Respiratory syncytial virus-associated hospitalisation in adults with comorbidities in two European countries, PROMISE investigators, preprint, August 2023
[4] Centers for Disease Control and Prevention (CDC), RSV in Older Adults and Adults with Chronic Medical Conditions, 2023
[5] Zwaans WA et al., The relevance of respiratory viral infections in the exacerbations of chronic obstructive pulmonary disease-A systematic review, in J Clin Virol 2014;61:181-188
