BIOVACSAFE · Biomarkers For Enhanced Vaccine Safety

BioVacSafe is a concise consortium of selected academic, public, and SME participants used to co-working in industry-led projects, organised into focused Activity Cores to generate 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. A compact interlocking structure provides efficient and cost-effective goal delivery, while offering the full spectrum of functionality and capacity to match the needs for predictive biomarkers and models of inflammation/autoimmunity and clinical events classification. A Technology Core has transcriptomics, genotyping, proteomics, metabolomics and data mining, with depth and capacity to discover, validate and distribute novel biomarkers. A Models Core has a full range of ex vivo/in vivo murine, small animal and non-human primate models of inflammation and biomarker discovery, with advanced immunology and imaging. A Clinical Core has capability to safely and efficiently distribute clinical studies of vaccine immunosafety from small intensive trials to large-scale studies of adult, paediatric and other populations. A Populations Core has population-scale biobank discovery, clinical cohorts (with globalisation capability, autoimmune, chronic, inflammatory and infectious disease groups), large-scale genotyping and sequencing, and a safely accessible central database for online analyses of large datasets. A Regulatory Core with expertise to synthesise outputs to generate and disseminate classifications, guidelines, reference standards for vaccine development, and inform EFPIA activities. A Management Core with track record of successful public-private projects ensures Cores interoperate to maximise discovery - validation - application - re-discovery cycles, to deliver project goals on time, within budget, while maximising interactions with other actors (EFPIA, FDA, EMA).