Translational Research to Generate Evidence for Rational and Efficient Introduction of New Vaccines in Developing Countries: The Experience of the International Vaccine Institute

Abstract

Introduction of new vaccines into affluent countries has occurred at a breathtaking pace in recent years. By comparison, few new-generation vaccines have been introduced into public health programs for the poor in developing countries, and, for those that have, introduction has been painfully slow. Limited financial resources have retarded the introduction. However, the slow pace also stems from a dearth of evidence needed for rational policy decisions. Inadequate support to conduct phase 1 studies of vaccine candidates targeted against diseases of developing countries is a well-known obstacle. Additionally, other types of translational research are needed to generate the necessary evidence for policy. Many vaccines have been shown to perform less well in impoverished populations in the developing world than in persons residing in more affluent countries. Consequently, phase 2 and phase 3 trials are a second essential type of translational research needed for the introduction of vaccines in developing countries. Moreover, even for vaccines that achieve licensure via clinical trials in developing countries, doubts may remain about whether the burden of disease warrants vaccine introduction, whether the administration of the vaccine in public health programs will be cost-effective, whether vaccine introduction will be programmatically feasible and acceptable, and whether the introduction of the vaccine will be financially sustainable. To address these residual doubts, a third type of translational research is needed. Since its inception in 1987, the International Vaccine Institute, an international, non-profit research and development organization located in Seoul, Korea, has conducted translational research on new vaccine introduction for a variety of diseases in 22 countries in Asia, Africa and Latin America. In this paper, we describe translational research projects undertaken by the International Vaccine Institute and lessons learned about strategies to increase the impact of translational research on vaccine policy for the developing world.