Preparing for RSV Immunisation and Surveillance in Europe

RSV causes severe disease in the very young and elderly and results in substantial healthcare costs.

In the last 4-years, substantial progress has been made in development of products for active and passive immunization against RSV, with 19 products currently in clinical development.

In 2017, we were funded by IMI to set up RESCEU project (Grant Agreement number 116019), which is the single largest consortium currently working on RSV and has addressed several of the key evidence gaps to inform the introduction of an RSV vaccine.

However, new gaps in evidence have emerged and many key requirements for the introduction of a novel RSV vaccine into national immunisation programmes (not addressed within RESCEU) remain unmet.

PROMISE’s vision is to seamlessly build on, exploit, and add value to the significant achievements of RESCEU to prepare for the imminent introduction of an RSV vaccine.

Expanding the existing RESCEU network to include 5 new partners, PROMISE comprises of 5 distinct but inter-connected work packages (WPs).

WP 1 will conduct epidemiological and cost-effectiveness analyses marshalling data from systematic reviews; national and regional disease registries; surveillance programmes and linked routine healthcare datasets.

WP2 will foster a consensus and develop an operational plan for expanded coordinated RSV surveillance and reporting activities; post-licensure monitoring and evaluation of products for RSV immunization across Europe.

WP3 will initiate new prospective studies to address key gaps in existing knowledge (RSV disease severity scores, asthma in school age children) and assemble biobanks for biomarker validation.

WP4 will validate temporally and at mucosal level biomarkers that were identified in RESCEU adopting state of the art technologies.

WPs 1-4 will develop high-quality, sustainable, robust data collection systems that link closely with public health/regulatory bodies/health care providers for informing policy and regulatory processes.