Accelerated Development of Vaccine Benefit-Risk Collaboration in Europe [ADVANCE]

Last updated on 1-4-2019 by Bernadette Latour
October 1, 2013
September 30, 2018

Partners

In short

ADVANCE is a European project that aims to assess the benefits and risks of vaccination programs. The objective is to develop a European infrastructure prototype to carry out scientific studies capable of rapidly determining the benefits and risks associated with vaccination programs. ADVANCE also aims to inform the authorities so as to enable them to make rapid decisions about vaccines already on the market and assess the need for revising vaccination programs already in place.

Project summary

The purpose of ADVANCE is to assess the benefits and risks of vaccination programs. It is a public-private partnership that is financed by the IMI (Innovative Medicine initiative — consortium between the European Commission and the EFPIA, the European Federation of Pharmaceutical Industries and Associations).

The objective is to develop a European infrastructure prototype that should allow scientific studies to be carried out to determine more rapidly the benefits and/or risks associated with vaccination programs. ADVANCE also aims to inform the authorities so as to enable them to make rapid decisions on administered vaccines (post-marketing) and assess the need for programs to be implemented.

It is important for the population to be correctly informed about the benefits and risks posed by vaccination programs and to understand better their long-term effects. Such a program should also reassure the segment of the population that is hesitant about vaccines and vaccination programs.

The objectives are:

  • to put in place a European infrastructure to accelerate studies aimed at assessing the benefits and risks of vaccines;
  • to develop and test a prototype of this infrastructure and entrust ECDC with the preparation of the blueprint and the implementation of the ADVANCE infrastructure beyond the funding provided by IMI;
  • to develop a good practice guide, code of conduct and governance model for public-private collaboration by ensuring transparency and maintaining public trust (WP1);
  • to identify the databases in Europe for carrying out these studies, collect the metadata from these databases and describe the procedures for accessing them (WP3);
  • to improve and standardise the vaccine coverage estimation methods, burden of disease/evolution of diseases, benefits, risks and benefit/risk ratio of vaccines (WP4); and
  • to conduct proof-of-concept studies to test the current structure and document the processes to be improved (WP5).

Sciensano participates in WP1, WP3, WP4 and WP5.

RESULTS

ADVANCE achieved the following results:

Environment and governance readiness:

  • Engagement of 47 partners across 19 European countries, including:
    • academic/public research institutions
    • public health organisations
    • national drug regulatory agencies, including the EMA and ECDC
    • vaccine manufacturers,
    • small medium enterprises
    • charities.
  • Development of best practices (code of conduct) and governance for collaborative vaccine studies.

Methods readiness:

  • Overview of existing and novel methods for estimation of vaccine coverage, benefits and risk estimation
  • Development of online tools to support vaccine research.

Data source readiness:

  • Development of an online catalogue of potential data sources for vaccine research
  • Establishment of processes and workflows to assess whether data sources are fit for purpose
  • Characterisation of 19 data sources in 8 countries
  • Development of an Interactive Dashboard to show near real-time monitoring of vaccine coverage, benefits and risks.

Study readiness:

  • Development of a best practices guidance for collaborative studies
  • Double coded R and SAS syntax programs to transfer raw healthcare data into a common data model
  • Operational platform to transfer, share and pool data.

Implementation plan:

  • Development of a blueprint to describe how to use the ADVANCE systems, created by ECDC.

VAC4EU

To sustain the solutions developed under ADVANCE, an international not- profit legal entity, VAC4EU, will be created which will be a multi-stakeholder scientific community and an operational study network.

Acknowledgement

The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under ADVANCE grant agreement n° 115557.

For further information, please visit:

www.advance-vaccines.eu

www.vac4eu.org

QR code

QR code for this page URL