On March 1st 2012 the IMI-JU funded project – Biomarkers for Enhanced Vaccine Safety (BioVacSafe) – initiated its collaborative work to develop new tools that will improve the evaluation and monitoring of vaccine immunosafety.
BioVacSafe is a public private consortium of 19 partners involving three of Europe's leading vaccine producing companies, experts from major academic institutions, small and medium-sized enterprises (SMEs) and non-governmental organization (NGO) actors.
The total budget of the project is 30.2 millions of Euros and it will last for five years.
BioVacSafe aims at establishing tools, methods and guidelines for the evaluation of vaccine reactogenicity and enhancing immunosafety of novel vaccines. In that context, BioVacSafe partners have a unique opportunity to tackle the urgent need to establish new ways of collaboration among industry, academia, biotech companies, regulators and patients' organizations to promote and support R&D for safer vaccines.
A new approach to vaccine safety.....
Vaccines are widely acknowledged to be one of the cheapest and most efficient ways to combat infectious diseases in both developed and developing countries. With billions of doses of vaccines administered globally every year, vaccine safety has always been a top priority for pharmaceutical companies, regulators and the public alike. The need for new approaches, methods and tools, is a priority.
The BioVacSafe project will draw on the latest life science research findings to profile how individuals respond to the different components of vaccines at the cellular, genetic and molecular level. This will allow the Consortium to identify and characterize new biomarkers useful to identify warning signs that a candidate vaccine may be reactogenic. Meanwhile, the Consortium will develop new ways to identify, classify and record adverse reactions to vaccines. Furthermore, the BioVacSafe team will probe how natural illnesses and infections, particularly diseases of the immune system, interact with vaccines.
By coming up with novel ways to identify and better understand the mechanism of adverse reactions to vaccines at all stages of development, BioVacSafe will accelerate the development and introduction of a new generation of safer, more effective vaccines. Moreover, the new, more accurate tools developed by BioVacSafe should help to boost public confidence in vaccine safety.
A compact interlocking structure based on conceptual "Activity Cores" provides efficient and cost-effective goal delivery, while offering the full spectrum of functionality and capacity to match the needs for developing 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 for biomarker discovery 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 globalization 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 synthesize 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 work packages interoperate to maximize discovery - validation - application - re-discovery cycles, to deliver project goals on time, within budget, while enhancing interactions with other closely integrated actors such as FDA, EMA.