BioVacSafe will safely and efficiently conduct clinical studies of vaccine immunosafety for biomarker discovery from small intensive trials to large-scale studies of adult, paediatric and other populations, enrol clinical cohorts (with globalization capability, autoimmune, chronic, inflammatory and infectious disease groups), conduct large-scale genotyping and sequencing, and develop safely accessible central databases for online analyses of large datasets. It will synthesize outputs to generate and disseminate classifications, guidelines, reference standards for vaccine development, and inform EFPIA activities.