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Benefit-Risk decision-making in vaccinology

July 15, 2014 | Les Pensières, Annecy (France)

Fondation Mérieux convened a multi-disciplinary group of experts for the meeting, Perspective on Benefit-Risk decision-making in vaccinology, at Les Pensières conference center in Annecy, France June 23-25.

Benefit-Risk decision-making in vaccinology

The Benefit/Risk (B/R) evaluation of vaccines has been a key part of the regulatory approval process for the past 50 years. Although the U.S. Food and Drug Administration 2007 Amendment Act formally introduced the concept of B/R assessment as part of vaccine life-cycle management, systematic methodologies for B/R appraisal are still recent and there are few well-accepted models.

The panel of experts from academia, industry, international organizations and national public health institutes, worked together to:

  • Explore the specificities of Benefit/Risk evaluation of vaccines, looking at vaccination programs in different parts of the world,

  • Discuss the data needed and methodologies for analysis of B/R in vaccine development and post-marketing surveillance, including a presentation of the quantitative method, Multi-Criterion-Decision-Analysis (MCDA) and work done in the ADVANCE (Accelerated Development of Vaccine benefit-risk Collaboration in Europe) project,

  • Draw recommendations to optimize B/R assessment of vaccines and vaccination programs, with a particular focus on effective communication.

This conference was made possible thanks to an unrestricted grant from Sanofi Pasteur.

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