General
26 Nov 2013

Key organisations unite to improve benefit and risk assessment of vaccines

Leading organisations have joined forces to launch a unique project that will pave 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 five-year, €10.7 million ADVANCE (‘Accelerated development of vaccine benefit-risk collaboration in Europe’) project is supported by the Innovative Medicines Initiative (IMI) and brings together the European Centre for Disease Prevention and Control (ECDC), 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-coordinated by the Erasmus University Medical Center in the Netherlands, the University of Basel / University Children’s Hospital Basel in Switzerland, GSK Vaccines (coordinating the vaccine manufacturers in the project) in Belgium, and Synapse Research Management Partners (Project Management) in Spain.

Vaccines undergo rigorous safety testing before regulatory approval. However, efforts to monitor the coverage, benefits and risks of vaccines after approval are rather fragmented. The goal of ADVANCE is 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.

The key to the project’s success lies in the fact that it brings together representatives of all stakeholders, including public health bodies, regulatory agencies, health ministries, vaccine manufacturers, healthcare providers, and of course the general public.

Michel Goldman, IMI Executive Director explained: ‘Collaboration between these diverse groups is very sensitive. By bringing them together around the neutral platform offered by IMI, ADVANCE is in a unique position to pave the way for a framework that will make it easier to rapidly assess the benefits and risks of vaccines. This would help maintain public confidence in immunisation as a successful and effective public health tool to control infectious diseases.’

The Open University will contribute expertise on methodology for monitoring vaccine efficacy and safety. Professor Paddy Farrington and his team in the Faculty of Maths, Computing and Technology have developed new statistical methods to investigate the safety of vaccines, which can help to identify rapidly a problem with a vaccine if there is one, or to provide accumulating evidence of its safety if not.

Commenting on ADVANCE, Professor Farrington said: “This ambitious multidisciplinary project will provide new opportunities for collaboration between different teams in Europe, and will thus further enhance the public health benefits of vaccination programmes.”

Watch a video about Professor Farrington's work on vaccine safety assessment

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