GSK gets positive EMA panel opinion for Respiratory syncytial virus older adult vaccine

There are no RSV vaccines or specific treatments currently available for older adults. RSV causes over 270,000 hospitalisations and approximately 20,000 in-hospital deaths in adults aged 60 years and older each year in Europe.

GSK’s marketing authorisation application has been reviewed under accelerated assessment. This applies to products determined by the CHMP to be of major interest for public health and therapeutic innovation. The European Commission’s final decision is expected by July 2023.

The positive opinion is supported by data from the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase III vaccine efficacy trial. In the trial, the vaccine candidate showed 82.6% (96.95% CI, 57.9–94.1, 7 of 12,466 vs. 40 of 12,494) overall vaccine efficacy against RSV-LRTD in adults aged 60 years and older, meeting the primary endpoint. Efficacy was 94.6% (95% CI, 65.9–99.9, 1 of 4,937 vs. 18 of 4,861) in older adults with at least one underlying medical condition of interest such as certain cardiorespiratory and endocrino-metabolic conditions. The vaccine was generally well tolerated with an acceptable safety profile.

GSK’s RSV older adult vaccine candidate is also under regulatory review by the US Food and Drug Administration, Japan’s Ministry of Health, Labour and Welfare, and several other regulatory agencies, with decisions expected in 2023. Additional regulatory submissions will continue throughout this year.

GSK’s RSV older adult vaccine candidate contains a recombinant subunit RSV prefusion F glycoprotein antigen (RSVPreF3) combined with the Company’s proprietary AS01E adjuvant.