Professor of Paediatric Infectious Diseases and Global Health at University of Edinburgh (UEDIN).
“PROMISE will generate new data and resources that will improve our understanding of RSV particularly how this has changed in the context of the ongoing COVID-19 pandemic. We are now within sight of multiple products to immunise against RSV in different population groups and this project will lay the groundwork to facilitate the early introduction and uptake of these products in Europe.”
Professor of Paediatric Infectious Diseases and Immunology at University Medical Centre Utrecht (UMCU).
“In PROMISE, we will generate data allowing to enter a game changing period for Paediatrics, Obstetrics and Internal Medicine. Combining scientific data with patient involvement will ensure informed introduction of novel RSV therapeutics and prevention for one of the most important respiratory diseases.”
Head of Vaccine R&D Partnerships & Stakeholders Engagement Europe at Sanofi.
“Building on the strong collaborations established in RESCEU, PROMISE will further expand our knowledge of RSV and pave the way for the successful rollout of novel RSV immunizations addressing a high Global unmet need. This new consortium continues placing patients at the center and brings international experts together to establish sustainable solutions and support decision making.”
Unmet Medical Needs
Lack of awareness on RSV disease and its risks and complications among parents and caregivers.
Lack of validated biomarkers for severe disease that can have substantial negative impact on the development of a successful product licensed for use (e.g., effective vaccines or therapies).
Need for better monitoring strategies to assess the RSV impact on all infants and other vulnerable groups, as well as on healthcare systems.
Need for licenced RSV immunisation tools, since no products are yet available, despite more than 60 years of attempted vaccine or monoclonal antibodies development.
Barriers to compliance with prophylactic immunotherapies which diminish the benefits of such therapies and potentially increase the risk for serious RSV disease, for example due to the burden of monthly healthcare visits during the season.
Need to unite voices on the RSV burden, often globally unrecognized, and share the challenges (historical and present) to finding solutions and raising awareness, alongside the innovations forthcoming.
Need to prepare for the introduction of a novel immunisation tools into national immunisation programmes across Europe.
Emergence of genotypes resistant to monoclonal antibodies (mAbs) and vaccines as evidenced by the failure of suptavumab.
Enhance the value proposition for RSV immunisation by generating new insights on RSV and addressing current gaps, such as understanding the relationship between RSV infection and school age wheeze and asthma.
Validate biomarkers of RSV susceptibility and other markers supporting clinical development of RSV therapeutic and immunisation solutions.
Develop a robust surveillance network on RSV disease, with the goal of strengthening epidemiological and virological surveillance in Europe, sharing this data among public health institutes, and disclosing surveillance data to the community.
Evaluate the impact of COVID-19 on RSV epidemiology such as disease burden and seasonality with data gathered recently.
Develop methods to evaluate effectiveness and safety of RSV immunisation and therapeutic products post-licensure.
Engage with patient networks and promoting the dissemination of knowledge to a wide range of stakeholders, raising awareness, fostering connectivity, and promoting informed action.
Establish synergies with neighbouring initiatives to join efforts to achieve the project´s mission.
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement 101034339. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
The Innovative Medicines Initiative is a partnership between the European Union and the European pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA). It is working to improve health by speeding up the development of the next generation of medicines, particularly in areas where there is an unmet medical or social need. It works by facilitating collaboration between the key players involved in health research, including universities, research centres, the pharmaceutical and other industries, small and medium-sized enterprises (SMEs), patient organisations, and medicines regulators. IMI is the world’s biggest public-private partnership (PPP) in the life sciences.