Draft for public consultation - Blueprint of a framework to rapidly provide scientific evidence on post-marketing vaccination benefits and risk for informed decisions

public consultation

ECDC launches public consultation on the “Blueprint of a framework to rapidly provide scientific evidence on post-marketing vaccination benefits and risk for informed decisions”. The Blueprint is a result of work of the IMI ADVANCE project and 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.

Executive summary

ECDC has been part of IMI ADVANCE, which is a five-year project that brings together a range of organisations from the public and private 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 (Accelerated development of vaccine benefit-risk collaboration in Europe) project has 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. 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.

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.

In order to receive comments from the scientific community and other stakeholders, the Blueprint is open for public consultation. The deadline for submission of comments is 27 July, 2018. 

After commenting on the Blueprint, could you please take part in the short survey on interactive platform linked to the Blueprint: https://ec.europa.eu/eusurvey/runner/Survey_on_interactive_platform.

How to submit comments

Comments should be submitted using a specific template and sent to ADVANCE.WP7@ecdc.europa.eu.

Please note that the comments must clearly state the identity of the contributor (i.e. country, first name and surname, and affiliation in the case of contributions from individuals; or name of organisation in the case of contributions on behalf of an organisation). Contributors are kindly asked to mention the respective line and page numbers of the document to which their comment(s) refer.

Please read the detailed guidelines for submission of contributions and kindly note that only contributions following ECDC guidelines will be considered.

For more information on the processing of your personal data in the context of this consultation, please read the privacy statement.

The deadline for submission of comments is 27 July, 2018.