ADVANCE – Accelerated development of vaccine benefit-risk collaboration in Europe

ADVANCE is a unique project which aims to review, develop and test methods, data sources and procedures which should feed into a blueprint of an efficient and sustainable pan-European framework that can rapidly deliver robust quantitative data for the assessment of the benefits and risks of vaccines that are on the market. Such a framework would allow regulators and public health authorities to make fast, informed decisions regarding vaccination strategies, and help to maintain public confidence in vaccines, particularly when questions are raised in the media about the safety of specific vaccines.

Data on vaccine-preventable diseases, vaccination coverage and adverse reactions to vaccines exist in many places and diverse formats, such as electronic health records, disease surveillance systems, and other healthcare databases. The ADVANCE team will have to identify and profile data sources capable of yielding rapid access to information on the burden of disease, vaccine coverage, and the benefits and risks of vaccines.

The project will run a number-of-proof of concept studies to ensure the platform meets the needs of its users. In order to cover the most common situations, these studies should ideally cover different age groups (e.g. infants / children, adolescents and adults / the elderly), different risk groups (e.g. pregnant women, people with other underlying health problems), and different vaccination scenarios (e.g. vaccinations given annually such as the flu jab, or vaccines introduced into the routine immunisation programme).

ADVANCE will also set out the framework’s core values, covering issues such as scientific best practice, a code of conduct, and rules for interactions between the different stakeholders.

In all aspects of its work, ADVANCE will build on the results of, and exploit synergies with, related projects. For example, the team will work closely with IMI’s EMIF project on data frameworks, and draw on the PROTECT project’s expertise in analysing and visualising the benefits and risks of medicines.