Vaccines undergo rigorous testing prior to licensing for use, however it is important that the safety of vaccines is monitored on an ongoing basis. The ADVANCE project, managed by Synapse and sponsored by the Innovative Medicines Initiative Joint Undertaking (IMI JU) and the EFPIA companies, is aimed 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. This framework will make it easier for regulators and public health authorities to make fast, more informed decisions regarding vaccination strategies. Moreover, it will help to maintain public confidence in immunisation, particularly when questions are raised about the safety of specific vaccines.
ECDC is leading one of the work packages within the project which focuses on developing a Blueprint for a framework for an integrated EU level vaccine benefit-risk system. The Blueprint includes a description of components, dependencies, workflows, stakeholder involvement and roles, access to the platform/tools developed and tested as part of the project, the entity (entities) in charge of running the platform/tools, and options for financing to ensure sustainability of the proposed solution.
The Blueprint is open for public consultation, we encourage members of the scientific community and other stakeholders to provide their feedback. The deadline for submission of comments is 27 July, 2018. There will be an interactive user-friendly version of the Blueprint, for this purpose a survey was created to gather ideas and user requirements. It will take few minutes only, your input is valuable to us and will be helpful for building a better interactive platform for the Blueprint.