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.