Drug Saf

Introduction Understanding the balance between the benefits and risks of vaccination is essential to ensure informed and adequate public health decision making. Quantitative benefit–risk models (qBRm) represent useful tools to help decision makers with supporting benefit–risk assessment throughout the lifecycle of a medical product. However, few initiatives have been launched to harmonise qBRm approaches, specifically for vaccines. Objectives The aim of this paper was to identify publications about qBRm applied to vaccines through a systematic literature review, and to describe their characteristics. Methods Medline, Scopus and Institute for Scientific Information Web of Knowledge databases were searched to identify articles in English, published from database inceptions up to December 2019. The search strategy included the combination of three key concepts: ‘benefit–risk’, ‘modelling’ and ‘vaccines’. Data extracted included the modelling context and the methodological approaches used. Results Of 3172 publications screened, 48 original publications were included. Most of the selected studies were published over the past decade and focused on rotavirus (15), dengue (10) and influenza (6) vaccines. The majority (30) of studies reported analyses related to high-income countries. The methodology of the studies differed, particularly in modelling techniques, benefit–risk measures, and sensitivity analyses. The present work also pointed out a high level of variability in the quality of reporting across studies, with particular regard to input parameters and methodological approaches. Conclusions This review provides an extensive list of qBRm applied to vaccines. Discrepancies across studies were identified during our review. While the number of published qBRm studies is increasing, no reporting guidance for qBRm applied to vaccines is currently available. This may affect decision makers’ confidence in the results and their benefit–risk assessment(s); therefore, the development of such reporting guidance is highly needed