Acta Tropica 80 (2001) 119–124

Immunization in the 21st century—the way forward

B. Melgaard *World Health Organization, Vaccines and Biologicals, CH-1211 Gene�a 27, Switzerland

Received 29 May 2000; accepted 15 January 2001

Abstract

Major changes will impact the way national immunization programmes and services are planned and implementedover the next decade and beyond. This paper presents the most significant health policy contexts, the relevant featuresof health systems development and new prospects for service delivery. It outlines ways of transforming a dedicateddisease control programme, polio eradication, for a broader health agenda. Progress anticipated in research for newvaccines and technologies is described. Reaching the new targets being established will require strong partnerships andthe recent creation of the Global Alliance for Vaccines and Immunizations is an important step in this direction.© 2001 Elsevier Science B.V. All rights reserved.

Keywords: Immunizations; Health policy; Health systems; Health services

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1. Introduction

The global health agenda of the first decade ofthis new millennium will position health as adeterminant of economic growth thereby placingthe health of people at the centre of developmentstrategies. Central themes to this end will include:(a) reducing the burden of excess mortality anddisability, especially that suffered by poor andmarginalized populations; (b) reducing risk fac-tors associated with major causes of diseases; and(c) developing health systems which are managedin a way which ensures equitable health outcomesand cost-effectiveness.

Vaccines and immunization have an importantrole to play within each of these themes. There

will however be major changes in the way inwhich vaccines are developed and delivered. TheExpanded Programme on Immunization (EPI) aswe know it will become a relic of the past ashealth systems undergo radical changes and tech-nological development transforms our concept ofan efficient and effective health service.

2. Health policy and immunizations

2.1. Children’s rights

The Children’s Rights Convention stipulatesthe right of every child to be protected againstinfectious disease. Access to immunization ser-vices is seen as a core element and must beprovided by every government as a fulfilment ofits endorsement of the Convention.

* Tel.: +41-22-791-4408; fax: +41-22-791-4227.E-mail address: melgaardb@who.int (B. Melgaard).

0001-706X/01/$ - see front matter © 2001 Elsevier Science B.V. All rights reserved.

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B. Melgaard / Acta Tropica 80 (2001) 119–124120

2.2. Po�erty reduction

Poverty alleviation through improvements inhealth is moving towards centre stage of theglobal development agenda. Strengthening theimpact of immunizations will become a centre-piece for health development strategies. This isevident both from the corporate strategic agendacurrently under development within WHO andfrom recent discussions on health and povertybetween bilateral partners and WHO.

2.3. Equity and cost-effecti�eness

Immunization will be seen as the most cost-ef-fective intervention in driving forward the deliv-ery of a health package to the poorest childrenin the world and will therefore be a priorityintervention.

3. Health systems and immunizations

3.1. Health reforms/health systems de�elopment

While health reforms sweep across most devel-oping countries and countries in transition, les-sons are being learned on seizing opportunitiesand mitigating the negative impacts ofdecentralization.

Two essential lessons have been learned fromcountry studies and are enabling the strengthen-ing of the role of immunizations in reformedhealth systems:1. essential immunization functions must remain

at central level. These include policy formula-tion and strategy development, vaccine pro-curement, monitoring and reporting ofnational trends and applied research; and

2. decentralization provides opportunities toreach larger populations than is already thecase through devolution of authority and bud-get allocations to the district level, the estab-lishment of performance contracts that includecoverage targets, the linking of planning andbudgeting, the identification of local needs andthe improved coordination with other sectorsand communities.

3.2. The polio platform

Polio will be eradicated early in the nextdecade, but that is not enough. The huge invest-ment in human and technical resources madeduring the polio eradication effort is a platformupon which immunization and other preventiveservices must build in order to achieve maxi-mum gains. Recognizing the potential of thecurrent polio eradication delivery structure, seiz-ing this opportunity and sustaining the resourcesavailable are major challenges for the partnersof the Global Alliance for Vaccines and Immu-nization (GAVI) and for the broader healthcommunity.

Five health systems elements have been iden-tified as particularly relevant to immunizationsin general and to polio in particular (see Table1).

Work is ongoing to identify subsets of theseelements which are of specific importance to im-munizations. These will be strengthened as partof focused health systems development.

3.3. Financing and financial sustainability

The new Global Fund for Children’s Vaccine(GFCV) set up by GAVI, has received commit-ments of close to 1 billion US dollars and willbecome a major new financing instrument forthe poorest countries.

National budget lines for vaccines are consid-ered an essential element in ensuring that finan-cial sustainability is established in a phasedmanner. The European Union project in WestAfrica is an example of such a mechanism. Thecreation of a new financing facility by the AsianDevelopment Bank is another example.

The new debt relief initiative for the highly-in-debted poor countries (HIPC) is likely to focuson the health sector. It is expected that thestrategy employed will concentrate on a set ofhighly cost-effective interventions targeting high-burden diseases.

President Clinton has initiated a number ofactivities which aim at making new vaccinesavailable to the poorest countries cheaply andquickly.

B. Melgaard / Acta Tropica 80 (2001) 119–124 121

4. Health services

4.1. Disease targets

The eradication of poliomyelitis will beachieved early in this decade but much workremains to be done in order to achieve the certifi-cation of eradication, anticipated for the year2005 (Fig. 1).

Measles remains the biggest vaccine-pre-ventable killer of children in developing countries.It will remain among the highest priorities on thepoverty agenda in the next decade. Three regionsof the world have set elimination targets; accelera-tion strategies are being introduced in other re-gions. The lessons learned from polio eradicationwill greatly influence the long-term strategies formeasles control, but the introduction of newstrategies is needed in order to reduce the unac-ceptable mortality and morbidity caused bymeasles.

The elimination of neonatal (and maternal)tetanus as a public health problem must receivenew impetus since many countries have faileddismally in reaching the mid-decade goals.UNICEF is in the process of launching a majorfundraising effort to mobilize resources for ahigh-risk strategy in selected countries.

Significant progress will be made to acceleratethe introduction of newer vaccines hepatitis B andHaemophilus influenzae type b, in poor countries.Milestones have been set by GAVI to this end.The GFCV will assist in the financing of thesevaccines. It is expected that a pneumococcal vac-cine will be available very soon with the potentialfor a significant reduction of death and diseasecaused by acute respiratory infections.

4.2. Management

A new concept based on the following willprovide the direction for a fundamental change inmanagement and supervision at national and dis-trict levels:1. a reference base will be created and made

accessible at various levels;2. a virtual management network, based on elec-

tronic means, will tie together global, regional,national and sub-national management fociand will provide access to tools and helpdeskssupporting all functions of immunization ser-vices; and

3. national hubs for managers of core interven-tion functions will be established and sup-ported in Ministries of Health.

Table 1A platform for immunization and preventive health services—opportunities provided by the Polio Eradication Initiative

Global outcomes (long-term)Opportunities provided by PEIPlatform elements

Political commitment Political visibility and common goal of PEI Global ‘re-visioning’ of EPI by 2000 fullyis used to improve ownership and supported by new financing mechanisms.sustainability of child health programmes.

International partnerships PEI ‘engine’ of international partnerships is Global alliance of traditional andnon-traditional partners mobilized to supportexpanded to address other child survivalimproved delivery of immunization andissues.preventive child health services.

Equity in access Lessons learned from PEI about ‘reaching Reduced child mortality and morbidity ofthe unreached’ are used to promote access vaccine preventable diseases.to all poor children in all countries.

Surveillance capacity PEI is used to strengthen routine Surveillance system, laboratory infrastructureand diagnostic capacity exists to supportsurveillance systems for priorityother disease control strategies.communicable diseases.Establishment of Preventive HealthIntegration of preventive PEI used as the ‘bridgehead’ for integrated

delivery of other preventive healthservices with EPI Programmes centering on immunization andinterventions with EPI. effective child health inventions.

B. Melgaard / Acta Tropica 80 (2001) 119–124122

Fig. 1. Cost of improving coverage. From current levels to 80% by 2005 in 43 countries with GNP�1000 USD and current DTP3coverage�80%. Incremental cost of 535–713 million USD to reach 35.7 million additional children.

B. Melgaard / Acta Tropica 80 (2001) 119–124 123

The new management network will provide themost important tool for dynamic changes in thepolicies and strategies employed by governmentsfor immunization goals and targets.

4.3. Immunization deli�ery strategies

Children most likely to die as a result of acuterespiratory infection or diarrhoeal illness are thosewho live on the margins of, or beyond the reach ofexisting health services. Major changes will occurin the way in which immunization services areorganized and delivered.

Innovative steps are being taken to improveaccess to immunization services and to reach theunreached, using lessons learned from polio eradi-cation as a basis from which to move forward.Efforts such as these will help improve equity andprovide better health services to the poorest chil-dren of the world (see Table 2).

They will constitute a central strategy in thestrengthening of routine immunization services,which are the cornerstone of EPI.

4.4. Safety of �accines and immunization

This is being addressed as a matter of priority.Promoting injection safety has become a priority

for UNICEF and WHO. The creation of the Safetyof Injection Global Network (SIGN) in late 1999signals a new impetus to broaden the base for workto reduce transmission of disease from unsafeinjections beyond the classical EPI sphere.

Adverse events are having an increasingly impor-tant effect on public confidence in immunizations.A new adverse event surveillance and responsesystem is under development and must receive thenecessary funding to ensure it meets its objectives.

4.5. Assessment, planning and monitoring

New assessment and planning tools are underdevelopment. Three modules are being prepared:core functions of immunizations, financing andintroduction of new vaccines. It is important thatall partners (governments, foundations, multilat-eral agencies and bilateral donors) adopt thesetools. This will ensure consistency and reduce theburden of work on the poor countries with limitedcapacity for planning, budgeting and reporting.

Methods to estimate the burden of disease andsurveillance of priority diseases must receive higherattention. Tools, methods and technical assistanceare being offered to help strengthen national mon-itoring/surveillance systems, and to improve thequality of data collected, in order that they can beused as evidence for decision-making on publichealth issues. A core monitoring system for theglobal targets established by World Health Assem-bly as well as the milestones set by GAVI will beput in place by WHO.

5. Research and development

Research investments must be focused on themost cost-effective health tool—vaccines againstorphan diseases with high disease burden in devel-oping countries but with no vaccine-market po-tential in the industrialized world (see Fig. 2).

New initiatives in this area are moving fast andthe establishment of the GFCV will reassure in-dustry of the existence of markets for orphanvaccines. The proposal for the establishment of aMillennium Fund for orphan vaccine develop-ment may— if it becomes reality—make it possi-

Table 2Strengthening out-reach services

SOS aims to deliver tailor-made immunization services onthe basis of periodic contact with people with limited orno access to health services due to geographic remotenessSOS builds on the experience of various countries and

draws lessons from polio National Immunization Days(NIDs)

SOS combines the delivery of immunizations withadditional interventions, depending on specific needs:– distribution of impregnated bed nets– livestock immunization– micro-nutrient supplementation, etc.

SOS is heavily based on community participation– determination of the basket of services– facilitation of the teams– choice of focal points to gradually receive additionaltraining in basic health services

Fig. 2. Number of childhood vaccines routinely used indeveloping and established market countries.

B. Melgaard / Acta Tropica 80 (2001) 119–124124

ble to open a ‘window’ in GFCV for research anddevelopment. Safe vaccines against pneumococci,shigella, rotavirus, meningitis A, HIV, malaria,HPV and hopefully TB, will exist before the endof the decade.

Technological innovations will move forwardwith heat-stable vaccines delivered by needle-freedevices being the long-term objective.

The following targets are being discussed forthe next decade:1. vaccine delivery systems which do not require

refrigeration;2. a delivery system which is closely integrated

with that of drugs;3. the use of safe, pre-filled injection devices con-

taining heat-stable vaccines; and4. The establishment of waste processing mecha-

nisms to avoid harm to the environment.

6. Partnership

GAVI is the new umbrella that embraces apartnership of all major global and nationalstakeholders. GAVI will unite its partners arounda set of agreed objectives ranging from currentlyestablished goals such as polio eradication and

measles control, to future achievements such asthe development and application of HIV andmalaria vaccines. GAVI will not become an oper-ational entity in itself, but will hold its partnersaccountable for the tasks that each commits itselfto undertake.

The establishment of GAVI has led to a signifi-cant increase in financial and political commit-ment to immunizations such as the verysignificant contributions by the Gates Foundationand bilateral and multilateral agencies.

The strategic objectives that will guide the earlyefforts of GAVI are:1. improving access to sustainable immunization

services;2. expanding the use of all existing safe and

cost-effective vaccines;3. accelerating the development and introduction

of new vaccines;4. accelerating research and development efforts

for vaccines and related products specificallyneeded by developing countries, particularlyvaccines against HIV/AIDS, malaria and tu-berculosis; and

5. making immunization coverage a centrepiecein the design and assessment of internationaldevelopment efforts, including debt relief.