PROMISE is a project that aims to address current gaps in respiratory syncytial virus (RSV) epidemiology, which causes severe disease in the very young and elderly. Estimates have shown that RSV is associated with 33.1 million cases of acute lower respiratory tract infection (ALRI), 3.2 million ALRI hospitalisations and 118,200 deaths in children younger than 5, each year.
Building on the achievements, established networks, governance processes and resources from the RESCEU project, PROMISE’s vision is to prepare EU countries for the introduction of an RSV vaccine.
What is PROMISE?
Preparing for RSV Immunisation and Surveillance in Europe
PROMISE is a project that brings together translational scientists, clinicians, public health agencies, the pharmaceutical industry, patient groups and clinical societies from 22 world class organisations to make a breakthrough in RSV research.
Specifically, this initiative focuses on advancing scientific knowledge on RSV to inform public health strategies and bolster the development and introduction of novel immunisations tools and therapeutics in Europe. Since the development of preventative measures such as a vaccine and monoclonal antibodies are well under way, PROMISE aims to prepare for the introduction of such treatments and prophylactic interventions.
Why is PROMISE needed?
Over the last few years, substantial progress has been made in development of products for active and passive immunisation against RSV. However, new gaps in evidence have emerged and many key requirements for the introduction of a novel RSV vaccine into national immunisation programmes remain unmet.
What is Penta’s role in the project?
As a Partner within the PROMISE Consortium, Penta coordinates the Ethics oversight and leads the interactions with the European and national medicines institutions. Specifically, Penta liaises with the EMA on regulatory guidance and policy guidance on post licensure requirements. Furthermore, Penta also conducts patient engagement activities and Citizen Science to optimise the development of RSV immunisation and therapeutics and to facilitate the introduction of approved vaccines and drugs in society.
Visit the PROMISE webpage.
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No. 101034339. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.