GSK’s respiratory syncytial virus older adult vaccine candidate gains positive CHMP opinion.

This is the first time an RSV vaccine candidate for adults has gained a positive opinion, one of the final steps in the marketing authorisation procedure prior to approval by the European Commission.

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. If approved, GSK’s candidate has the potential to be the first vaccine available to help protect older adults from RSV disease.

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. The most frequently observed solicited adverse events were injection site pain, fatigue, myalgia, headache, and arthralgia. These were generally mild to moderate and transient.