Project launches to rapidly deliver data on vaccines

A new five-year project will bring together multiple organizations from the private and public sectors to improve benefit and risk assessments of vaccines, the European Centre for Disease Prevention and Control recently announced.

The "accelerated development of vaccine benefit-risk collaboration in Europe" project, also known as the ADVANCE project, will unify monitoring efforts on determining the benefits and risks of vaccines after approval. While vaccines undergo rigorous safety testing prior to regulatory approval, attempts to monitor vaccines after approval are disjointed.

The five-year, $14.5 million project is meant to review, develop and test methods, procedures and data sources to come up with a sustainable and efficient framework to deliver data to assess the benefits and risks of marketed vaccines in Europe. The framework could help regulators and public health officials to make more informed decisions related to vaccination strategies. It could also maintain public confidence in immunization, especially when questions are raised about the safety of certain vaccines.

The ECDC is leading one of the project's work packages which focuses on determining how well solutions coming from other parts of the project can be implemented. The ECDC will also come up with a blueprint for a framework for an integrated European Union level vaccine benefit-risk system.

The project is supported by the Innovative Medicines Initiative and brings together small- and medium-sized enterprises, academic experts, national public health and regulatory bodies, vaccine manufacturers and the European Medicines Agency. The project is being coordinated by the Netherlands-based Erasmus University Medical Center, the Switzerland-based University of Basel/University Children's Hospital Basel, the ECDC and the Spain-based Synapse Research Management Partners.