1. Anne Schuchat, MD Director, National Center for Immunization and Respiratory Diseases, CDC Assistant Surgeon General, US Public Health Service CVEP Symposium on Global Vaccine 202X : Building Access, Equity, Impact Philadelphia, PA May 2, 2011 Value of Evidence in Immunization National Center for Immunization & Respiratory Diseases Atlanta, Georgia, USA

2. What if… 97% reduction vs. baseline Vax X introduction

4. What if… “Postmarketing surveillance indicates the possibility of an increased risk of intussusception shortly after the first dose of rotavirus vaccine in some populations ”

5. AdmissionsDeaths Rotavirus events averted by vaccination -12,000-700 Intussusception events caused by vaccination* +43+2 Benefit to Risk comparison 300 to 1 Mexico: Rotavirus Vaccination Benefit versus Risk 5 *background IS rates: Patel et al. Exp Rev Vacc; 2009; 8(11) Assumes IS risk for wk 1 after vaccination; with assumption of 5% case-fatality Risk estimates from Mexico/CDC/PAHO, funded by PATH and GAVI Slide: Courtesy M Patel and U Parashar, CDC; Derived from Mexico MOH/CDC/PAHO study

6. Risk-Benefit Estimates for Developing Countries in Africa and Asia ~ 2500 intussusception cases caused Risks Benefits 250,000 rotavirus deaths prevented

7. What if… introduction

8. Predicted relative incidence rotavirus gastroenteritis following vaccine introduction Source: C Atchison, J Edmunds, M Patel, U Parashar, D Payne, B Lopman. Natural dynamics of mass rotavirus vaccination. 9 th Int Rotavirus Symposium. Johannesburg, 2010 introduction

9. 200820092010 Genetic Clusters of Poliovirus 1 Virologic Progress in Africa 2008 2009 2010 Slide courtesy Mark Pallansch, CDC

10. Who Needs What When  Local  National  Regional  Global  Disease burden  Program impact  Lab characterization  Cost-effectiveness  Adverse events  Vaccine efficacy  Vaccine uptake  Pre-licensure  Multi-year planning  Post-introduction  Pre “graduation”

12. Ongoing Evidence Needs People Vaccine-preventable diseases Adverse events Acceptance Product Effectiveness, duration Supply chain management Stock-outs Predictability Program Efficiency Self-correcting Equity

13. Evidence and Danger  Danger of not looking  Danger of looking without adequate tools  Danger of ignoring adverse event considerations  Danger of failing to self-correct Evidence = insurance policy on vaccine investments