Series www.thelancet.com Published online June 9, 2011 DOI:10.1016/S0140-6736(11)60406-6 1 New Decade of Vaccines 4 The future of immunisation policy, implementation, and financing Orin S Levine, David E Bloom, Thomas Cherian, Ciro de Quadros, Samba Sow, John Wecker, Philippe Duclos, Brian Greenwood Vaccines have already saved many lives and they have the potential to save many more as increasingly elaborate technologies deliver new and effective vaccines against both infectious diseases—for which there are currently no effective licensed vaccines—such as malaria, tuberculosis, and HIV and non-infectious diseases such as hypertension and diabetes. However, these new vaccines are likely to be more complex and expensive than those that have been used so effectively in the past, and they could have a multifaceted effect on the disease that they are designed to prevent, as has already been seen with pneumococcal conjugate vaccines. Deciding which new vaccines a country should invest in requires not only sound advice from international organisations such as WHO but also a well informed national immunisation advisory committee with access to appropriate data for local disease burden. Introduction of vaccines might need modification of immunisation schedules and delivery procedures. Novel methods are needed to finance the increasing number of new vaccines that have the potential to save lives in countries that are too poor to afford them. Here, we discuss some options. Introduction Since Edward Jenner’s breakthrough in 1796, vaccination has probably saved as many lives as any other public health innovation, with the exception perhaps of improvements to sanitation and water safety. Without vaccines, global eradication of smallpox and elimination of poliomyelitis and measles from large parts of the world would have been impossible. These achievements have been accomplished largely with vaccines delivered through a global system, the Expanded Programme on Immunization (EPI), which has received sustained support for more than 30 years from national governments, donor organisations, and international agencies such as UNICEF and WHO. However, diseases such as pneumonia, diarrhoea, meningitis, and measles, which are currently preventable by vaccination, still account for about a quarter of child deaths in low-income countries (figure 1). 1–4 In adults, tuberculosis and cancers of the cervix, liver, and some other sites are also potentially preventable by vaccination and, yet, continue to cause much suffering and many deaths. With these past successes, rapid advances in biomedical sciences, and a delivery system that reaches nearly all children at least once in the first year of life, we have high expectations that new vaccines will further improve global health. Three major challenges exist to enhancement of current success in prevention of infectious disease by vaccination. First, we need to further expand coverage of existing vaccines, such as those against diphtheria, tetanus, and measles. Second, effective new vaccines need to be implemented widely, such as those against Haemophilus influenzae type b and pneumococcal, meningococcal, rotavirus, and human papillomavirus infections. Third, we need to develop new vaccines against important pathogens, such as malaria parasites and HIV, for which no effective licensed vaccine yet exists. Here, in the fourth paper of this Series, we focus mainly on the first and second challenges with respect to low-income and middle-income countries, because these areas are where the main challenges to introduction of new vaccines are found and where characterisation of policies, programmes, and financing necessary for further progress is most urgent. However, Published Online June 9, 2011 DOI:10.1016/S0140- 6736(11)60406-6 See Online/Comment DOI:10.1016/S0140- 6736(11)60765-4, DOI:10.1016/S0140- 6736(11)60766-6, and DOI:10.1016/S0140- 6736(11)60710-1 This is the fourth in a Series of five papers about the new decade of vaccines Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA (O S Levine PhD); Harvard School of Public Health, Harvard University, Cambridge, MA, USA (D E Bloom PhD); Immunizations, Vaccines & Biologicals, WHO Headquarters, Geneva, Switzerland (T Cherian MD, P Duclos PhD); Sabin Institute, Washington, DC, USA (C de Quadros MD); Centre for Vaccine Development, Bamako, Mali (S Sow MD); PATH, Seattle, WA, USA (J Wecker PhD); and London School of Hygiene and Tropical Medicine, London, UK (B Greenwood MD) Correspondence to: Dr Orin S Levine, International Vaccine Access Center, Department of International Health, Johns Hopkins Bloomberg School of Public Health, 855 N Wolfe Street, Suite 600, Baltimore, MD 21205, USA olevine@jhsph.edu Key messages • Access to vaccines for children in developing countries began to expand rapidly in the mid-1970s, with establishment of the Expanded Programme on Immunization, and has subsequently prevented many millions of deaths and illnesses • Immunisation programmes need ongoing review to account for changes in the epidemiology of major infectious diseases and availability of new vaccines • Vaccination policies should be based on solid evidence and rigorous science; efforts are underway to ensure that all countries have an established body that can make evidence-based decisions about vaccine policy • Experiences with new vaccines, such as pneumococcal and rotavirus vaccines, have shown that vaccine access for children in developing countries can be accelerated, but this process needs to be improved further to meet the needs of new vaccines on the horizon • Sustainable predictable financing is likely to be a major ongoing challenge to achievement of universal access to all vaccines; innovative ways are being developed to tackle introduction of pneumococcal and rotavirus vaccines, but financing of other new vaccines, which are likely to be at least as expensive, remains to be established • Continued vaccine research is needed to keep safe, effective vaccines in the pipeline