Vaccinomics: social and science systems in transition Farah Huzair Innogen, The Open University

1. Vaccinomics: social and science systems in transition Farah Huzair Innogen, The Open University

2. Vaccinomics • Changing paradigm of vaccines • What is vaccinomics? • What do personalised vaccines aim to do? • Vaccinomics innovation systems • Innovation and the regulatory framework • Issues and problems • The problem of exclusion for developing countries

3. Changing paradigm of vaccines • Assumptions underlying the current approach: • Everyone will react in the same way immunologically • Everyone is at approximately the same level of risk • Vaccine dose number and dose amount needed to • develop immunity are the same for everyone • Successful widespread, low cost, public health tool

4. What is vaccinomics? “Vaccinomics examines the influence of immune response gene polymorphisms on the heterogeneity of humoral, cell mediated and innate immune responses to vaccines both at the individual and population level” (Poland et al., 2008). Poland, G.A. et al. Identification of an association between HLA class II alleles and low antibody levels after measles immunizations. Vaccine 2001;20(34):430-8 Wang, C. et al. HLA and cytokine gene polymorphisms are independently associated with responses to hepatitis B vaccination. Hepatology 2004; 39(4): 978-88

5. What do personalised vaccines aim to do? • Different Target Levels • The individual level • The gender level • The racial/ethnic level • The sub population level • Aims • Reduce risk of AEFIs • Maximise dose effectiveness • Reduce clinical trial sizes • Reduce costs

6. Vaccine innovation systems Vaccinomics?

7. UK Biobank and the Human Variome Project Biological samples and patient history from 500,000 people aged between 40-69 years in 2006-2010 Established by the Wellcome Trust, Medical Research Council, Department of Health, Scottish Government and the Northwest Regional Development Agency. Non-profit charity, initial funding of £62 million The collection of mutations in all genes from all countries and work in: Ethics, Data Collection From Clinics & Laboratories, Data Transfer & Databasing (Gene Specific/LSDB), Integration and Access, Assessment of Pathogenicity, Developing and Emerging Countries and Worldwide collection, Nomenclature and Standards

8. Issues and problems • Vaccinating is cheaper than testing • Marginal benefit problem? • Change of paradigm compromising public benefits? • Ethics and public trust for use of genetic/genomic data • Subsets of population left without treatment?

9. The problem of exclusion • Strong regulatory framework with capability for enforcing • Skills base in regulatory science and CT’s • Adequate knowledge translation between the stakeholders involved • Physical infrastructure for storage and analysis of genomic data and samples • Public health system capable of integrating vaccinomics technologies and complimentary diagnostic tests • IT and information systems for phase IV and post market surveillance • Sufficient macro economic stability and capacity to engage with research and collaborate with international partners • Huzair, F. and Papaioannou, T. (2012) UK Biobank: Consequences for Commons and Innovation. Science and Public Policy 39 (4) 500-501. • Huzair, F and Borda-Rodriguez, A. (2012) Challenges for the application and development of OMICs health technologies in developing countries. Drug Dev Res (73: In press, doi: 10.1002/ddr.21036) • Huzair, F., Borda-Rodriguez, A and Upton, M. (2011) Twenty-First Century Vaccinomics Innovation Systems: Capacity Building in the Global South and the Role of Product Development Partnerships (PDPs). OMICS Vol 15, No 9, pp1-5. DOI: 10.1089/omi.2011.0036