Elsevier

The Lancet

Volume 378, Issue 9789, 30 July–5 August 2011, Pages 439-448
The Lancet

Series
The future of immunisation policy, implementation, and financing

https://doi.org/10.1016/S0140-6736(11)60406-6Get rights and content

Summary

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, 2, 3, 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, some issues discussed by us here are also relevant to high-income countries.

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

Recently developed vaccines, and some of those likely to arrive soon, share many characteristics. In general, they are substantially more complex and expensive than vaccines that preceded them. The new pneumococcal conjugate vaccines, for example, are combinations of ten or 13 individual vaccines and nearly a year is needed to manufacture one batch. Finding ways to ensure that these new vaccines are available and accessible to populations that most need them is a major challenge to the international community.

Section snippets

Origin and evolution of EPI

The foundations of the current global immunisation system can be found in a series of World Health Assembly resolutions starting in 1974. The success of the global smallpox eradication programme, recognition of the enormous potential for vaccination to control communicable diseases, and the fact that in many regions and countries of the world children did not have access to vaccines, led the Assembly to establish the EPI in 1974 (resolution WHA27.57). The first diseases targeted by this

Global framework for evidence-based immunisation policy

Countries, in particular developing countries, look to WHO for policy recommendations about use of vaccines in their national programmes. To meet this need, WHO solicits recommendations from independent advisory committees, which consist of experts with diverse backgrounds.

The main advisory group to WHO on vaccine policy and strategy is the strategic advisory group of experts (SAGE). Established in 1999 through the merging of two previous committees, SAGE was restructured in 2005. Its

Introduction of vaccines into national programmes

Historically, in wealthy countries with low mortality, new vaccines were incorporated rapidly into programmes, whereas in countries with the highest burden of disease, uptake was delayed by 15–20 years.14 The inequity represented by this paradoxical situation has led to enhanced efforts to better understand the drivers of new vaccine adoption in national programmes and to accelerate the process.

Research and past experience show that national policy makers need a set of key data and information

Capturing the full benefits of vaccination

Health decision makers have an opportunity to make important strides to increase child survival. Estimates suggest that vaccines avert more than 2·5 million child deaths a year and, if vaccine coverage was increased, prevention of up to 2 million additional deaths per year might be possible (figure 1). In addition to political factors, decision makers consider costs and benefits when setting health-system priorities. The traditional view of benefits includes forestalled costs of medical care

Financing vaccines now and in the future

Financing new vaccines represents a major challenge for all global and national programmes. Prices for new vaccines—such as those against rotavirus and pneumococcal disease—are high compared with those for traditional vaccines, and health ministries in many countries are struggling to accommodate the costs (table 2). The same is true for new adolescent and adult vaccines, such as the human papillomavirus vaccine, which can cost upwards of US$130 for each of the recommended three doses in some

The role of research

Development of new vaccines requires research in many disciplines, as reviewed in the first paper in this Series.41 Successful licensure of a new vaccine signals the beginning of a phase of research, not the end. Operational research that supports optimum deployment of vaccines is not always scientifically glamourous but is essential to maximise returns after application of time and funds needed to develop and license a new vaccine. Operational research can help identify either the best

Conclusions

Nearly 40 years after inception of EPI, the global immunisation system must prepare for a new decade of vaccines with unique challenges in terms of expanding surveillance for new diseases, financing development of more expensive vaccines, and increasing coverage of existing and new vaccines (panel 2). Several improvements at global level provide new capacity to support timely development of evidence-based global policies and to disseminate these to a growing number of capable local and regional

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