ADVANCE: Five-year project launched to improve benefit and risk assessments of vaccines
ECDC is part of a new project – ADVANCE, that brings together a range of organisations and sectors to improve benefit and risk assessments of vaccines.
Vaccines undergo rigorous safety testing before regulatory approval. However, efforts to monitor the vaccination coverage, benefits and risks of vaccines after approval are fragmented. The ADVANCE project (‘Accelerated development of vaccine benefit-risk collaboration in Europe’) aims to review, develop and test methods, data sources and procedures for an efficient and sustainable pan-European framework that can rapidly deliver robust, quantitative data for the assessment of the benefits and risks of marketed vaccines.
ECDC’s role in ADVANCE
ECDC is leading one of the work packages within the project which focuses on assessing the implementability of solutions coming through other parts of the project, by both an internal ECDC expert team and ECDC established Review Panels with external stakeholders. ECDC will also develop a blueprint for a framework for an integrated EU level vaccine benefit-risk system.
The five-year, €10.7 million ADVANCE project paves the way for a pan-European framework for rapidly assessing and communicating the benefits and risks of vaccines. Such a framework would make it easier for regulators and public health authorities to make fast, more informed decisions regarding vaccination strategies, and help to maintain public confidence in immunisation, particularly when questions are raised about the safety of specific vaccines.
The project is supported by the Innovative Medicines Initiative (IMI) and brings together the European Medicines Agency (EMA), as well as vaccine manufacturers, national public health and regulatory bodies, academic experts, and small and medium-sized enterprises (SMEs). ADVANCE is co-ordinated by the Erasmus University Medical Center in the Netherlands, the University of Basel / University Children’s Hospital Basel in Switzerland, GSK Vaccines (co-ordinating the vaccine manufacturers in the project) in Belgium, and Synapse Research Management Partners (Project Management) in Spain and ECDC.