Perspectives on benefit-risk decision-making in vaccinology: Conference report.

Benefit/risk (B/R) assessment methods are increasingly being used by regulators and companies as an important decision-making tool and their outputs as the basis of communication. B/R appraisal of vaccines, as compared with drugs, is different due to their attributes and their use. For example, vaccines are typically given to healthy people, and, for some vaccines, benefits exist both at the population and individual level. For vaccines in particular, factors such as the benefit afforded through herd effects as a function of vaccine coverage and consequently impact the B/R ratio, should also be taken into consideration and parameterized in B/R assessment models. Currently, there is no single agreed methodology for vaccine B/R assessment that can fully capture all these aspects. The conference "Perspectives on Benefit-Risk Decision-making in Vaccinology," held in Annecy (France), addressed these issues and provided recommendations on how to advance the science and practice of B/R assessment of vaccines and vaccination programs.