Author: Anna Beltrami

RESCEU Work Package 2 representatives met with the EMA Vaccine Working Party (VWP) on June 7^th 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.

An EMA ITF Briefing Meeting with RESCEU representatives took place on March 16^th at the EMA headquarters, as part of the RESCEU efforts for establishing continuous communication and collaboration with Regulatory Bodies.

The purpose of this collaboration is to allow RESCEU to receive fundamental regulatory input but also provide, thanks to its experts and the data generated within the project, a useful and valid scientific support to EMA for all those matters related to the development of medicinal products intended for the treatment and prophylaxis of RSV infection. The meeting started with the presentation of RESCEU, its structure and objectives for the next 4 years, and was followed by a discussion where RESCEU Leads sought advice on ways for communicating with EMA and clinically related topics, such as information that should be captured by the clinical studies in view of future regulatory discussion.

RESCEU’s clinical studies have started, with the aim of gathering data and addressing knowledge gaps on the impact of RSV infections. The investigation is building on the knowledge of a varied team of partners from universities and public health institutions, and includes 3 cohort studies on vulnerable populations (infants, older adults, COPD subjects) and one case-control study on infants after RSV infection.

The first symptomatic participants were tested and visited for Respiratory Syncytial Virus in the 3 mentioned clinical cohort studies. As the RSV season had not yet started, all tested patients were still RSV negative: we can expect that first RSV diagnosis and therefore more exhaustive results will be available only with the beginning of RSV season.