RESCEU Work Package 2 representatives met with the EMA Vaccine Working Party (VWP) on June 7th at the EMA in London, as part of the RESCEU efforts for establishing continuous communication and collaboration with Regulatory Bodies.
The meeting began with a presentation of RESCEU, including an overview of the project and a detailed explanation of the outputs of Work Package 2. This was followed by discussions on how the Work Package 2 estimates of RSV disease burden in Europe will be of benefit to the EMA.
RESCEU representatives and EMA VWP members agreed that Work Package 2 outputs will be of importance to the EMA as they will: highlight target groups for interventions, inform research investment prioritisation, inform the design of clinical trials (such as by aiding in the selection of appropriate outcomes and case/severity definitions), and produce “baseline” burden data that will help assess the impact of future interventions. RESCEU Work Package 2 will continue to engage with the EMA VWP, including sharing the results of the RSV burden estimates.