Biomarkers of Vaccine Immunosafety (BioVacSafe)

BioVacSafe is a consortium of vaccine manufacturers together with academic, public, and SME participants, organized into focused workpackages to generate and disseminate knowledge and tools to benchmark licensed vaccine reactogenicity, and create practical and generalizable guidelines and techniques to enhance immunosafety of novel vaccines from pre- development to post-marketing surveillance. It aims to develop predictive biomarkers, models of inflammation and autoimmunity, and clinical events classification through a series of clinical trials and population-based studies with parallel pre-clinical models. The consortium has capability in transcriptomics, genotyping, proteomics, metabolomics and data mining, with depth and capacity to discover, validate and distribute novel biomarkers. A full range of ex vivo and in vivo small animal models of inflammation and biomarker discovery, with advanced immunology and imaging are available.