The children's vaccine initiative

4 World Health • 46th Year, No. 2, Morch-Aprill993 The Children's Vaccine Initiative Frank Hartvelt Beyond the immediate objectives of the CV/ is the ultimate goal of a single oral immunization shortly after birth that will protect the world's infants against all major childhood diseases. I n September 1990, two historic events took place which represented a quantum leap for- ward for child survival and develop- ment. At the World Summit for Children, presidents, prime ministers and other representatives of 159 countries agreed to step up efforts and set. specific targets to improve the condition of the world's children in vital areas affecting their develop- ment: health, education, and chil- dren's rights. The targets to be reached by the year 2000 were consid- ered to be feasible and financially affordable. The overall goal for health, set globally, was to reduce child The need for better and new vaccines Despite the dramatic rise in child- hood immunization over the past 15 years - up to 80% in many countries - avoidable illness and deaths among children are still high. Improvement and development of existing and newvacci nes against bacterial and viral diseases could save the lives of an estimated 8 million children and prevent 900 mi llion severe illnesses among children annually . mortality among under five-year-olds by one-third, by the year 2000. A less publicized event occurred a few weeks before the World Summit, when an international group of experts in the field of vaccine research and application reviewed the contribution which improved and new vaccines can make during the current decade to the "Vaccines offer the greatest pros- pects for achieving rapid improve- ments in health. " Or 0 Ransome·Kuti, former Minister of Health , Nigeria. health of the world ' s children. The resulting "Declaration of New York" provided the scientific and industrial underpinning for the goal of childhood mortality reduction set by the world leaders. It stated specifically that the application of current science can lead to vaccines which can be given earlier in life, require one or two rather than multiple doses, keep their potency in tropical temperatures, can be given in the form of cocktails of several vaccines, and are affordable. In 1991 the Rockefeller Founda- tion, the United Nations Development Programme (UNDP), UNICEF, the World Bank and WHO launched the Children ' s Vaccine Initiative (CVI), joining their forces with vaccine research and development institutes, pharmaceutical companies, and na- tional and international development agencies. The resulting international coalition is unique in the goals set, its broad mandate, and the synergy of the activities of its national and interna- tional partners. Set against the ulti- mate goal of a single oral immunization shortly after birth that will protect the world 's infants against all major childhood diseases, the immediate objectives of the CVI are: • to facilitate provision of an ad- equate supply of affordable, safe and effective vaccines against important infectious diseases; • to accelerate the development and production of improved and new vaccines; • to simplify the complex logistics of vaccine delivery. Management structure What has happened since the incep- Universal immunization will make a major contribution towards good health for the world's children. World Heolth • 46th Year, No. 2, March-Aprill993 Developing countries ore making progress towards producing high quality vaccines. tion of the CVI? Its partners have moved ahead on three accounts: establishing an organizational struc- ture to guide and manage the CVI activities, initiating a strategic plan- ning process, and developing a heat- stable poliomyelitis vaccine and a single-dose tetanus toxoid vaccine. Today the CVI organization in- cludes: a Consultative Group which provides an international forum for consultation and review; a Manage- ment Advisory Committee to review strategies and programmes (a micro- cosm of the much larger consultative group); a Standing Committee com- posed of the five founding agencies, which takes its cue from the other bodies in approving the CVI strategy, work programme and budget; and, at the operational level, Product Devel- opment Groups designed to promote, facilitate and manage projects leading to the development of vaccines and related products. A secretariat, based in WHO, Geneva, supports the CVI bodies as outlined. Over the past year, two Product "A new relationship is needed between the public sector and industry to combat poverty. " Mr J P. Prank, Minister of Development Cooperation, the Netherlands. Development Groups have already made substantial progress in develop- ing a heat-stable poliovaccine (linked to the poliomyelitis eradication goal) and a single-dose tetanus toxoid vaccine, the latter with the potential to prevent 600 000 deaths per year. According to WHO senior officials and scientists familiar with interna- tional health programmes, the take-off phase of the CVI has been remarkably smooth. In fact, hundreds of highly motivated specialists are already working worldwide to push frontiers ahead in strategic planning, biotechnology, immunology, epidemi- ology, vaccine supply, quality control, regulatory matters, licensing, patents, and financial and legal issues. All these areas are interlocking parts of a complex mosaic. The CVI relies heavily on "up- stream" vaccine research carried out by the WHO/UNDP Programme for Vaccine Development, and on the "downstream" operations and experi- ence of the global Expanded Pro- gramme on Immunization (EPI) spearheaded by UNICEF and WHO which, by the end of 1990, reached 80% of the world's children with a protective course against the six major childhood diseases: poliomyelitis, measles, tuberculosis, diphtheria, pertussis, and tetanus. To make the EPI more effective the CVI aims to improve the heat stability of vaccines (e.g., poliomyelitis) and to reduce the CVI: For the sake of children The Children 's Vaccination Initia- tive (CVI) is on informal association of public and private groups dedi- cated to helping the world commu- nity to focus, accelerate and apply advances in the science, develop- ment, manufacture and efficient delivery of new and bettervoccines for the world's children. lt was launched in response to the Declaration of New Y ark, mode shortly before the World Summit for Children in 1990, which ca lled for a global commitment to the produc- tion and delivery of "ideal chil- dren 's voccines" that provide last- ing protection against a wide range of diseases, ore simple to adminis- ter and ore affordable. The CVI was established by the United Notions Children's Fund (UNICEF), the United Notions Development Programme (UNDP), the Rockefeller Foundation , the World Bank and the World Health Organization (WHO) , and has its secretariat at WHO's headquarters. A news bulletin ca lled CV/ Forum is published three times a year and is available on request from Dr Lindsoy Mortinez, CVI Secretariat, WHO, 1211 Geneva 27, Switzerland . Contributors to the CVI To dote, the following agencies and countries hove mode specific financial contributions : the found- ers - the Rockefeller Foundation, the United Notions Development Programme (UNDP), UNICEF, the World Bank, WHO -theAssocio- tion for Cooperation in International Health Uopon), Canada, the Euro- pean Commun ity, japan, the Neth- erlands, Rotary International and the USA In addition on increasing number of countries, agencies and companies ore undertaking activi- ties under the CVI umbrella . s 6 number of doses through the adminis- tration of vaccine cocktails. The implications are not only that more infants are reached but also that the cost of logistics, especially the cold chain, will decline, thereby potentially freeing funds for vaccine development and production and higher immuniza- tion levels. Among the constraints faced by the CVI are the soaring costs of vac- cine development and production, due to the high cost of industrial research and development through increasingly sophisticated technologies (e.g. , CVItarget diseases EPI vaccines Tetanus toxoid Heat-stable pol iomyelitis Measles Pertussis (w hooping coug h) Hepatitis B Licensed non-EPI vaccines Haemophilus influenzae type B Meningococcus Pneumococcus Typhoid genetic engineering), and the high insurance premiums that companies must pay against lawsuits stemming from possible side-effects. Another factor is the increased concentration of vaccine development and production in a few conglomerates which could lead to cartel price-setting. On the positive side, as suggested by large international vaccine manufacturers, a two-tier price structure is needed with a market price for developed countries and an affordable price for developing countries. In the scientific arena, exciting Unlicensed vaccines likely to be available within the next five years Dengue Enterotoxigenic E. coli Rotavirus Under consideration Malaria Shigella Tuberculosis In the foreseeable future, children under five will be vaccinated against a whole range of other diseases. World Health • 46th Year, No. 2, Morch-April l993 developments are anticipated in mi- cro-encapsulation whereby a vaccine contained in microcapsules is injected and - since the capsules are biode- gradable - is released over time, mimicking repeated injections. The live-vaccine-carrier approach is a second path towards a one-shot vac- cine; unrelated live viral or bacterial components will be used as carriers to deliver the required vaccines more efficiently. A third approach is to use micro-encapsulation and live-vaccine carriers for oral administration, thereby obviating the complex logis- tics of injections. Although private sector companies have shown much interest in the CVI, their concrete participation has yet to materialize. The dilemma to be over- come is to match corporate profits with public health goals; so national "Every day thousands of children die because they are not immu- nized . Conventional approaches must change to respond to the explosive demand for vaccines. " Or A. Merieux, President and Director- General, Pasteur Merieux Serums and Vaccines of France. and international agencies may need to guarantee large vaccine purchases over a period of years in order to induce companies to develop and produce them. More attention needs to be directed to building the capacity of developing countries to produce high quality vaccines and establish quality control mechanisms. From a wider development per- spective, immunization must go hand in hand with not only improvements in health services, water supply and sanitation, nutrition, family planning and education, but also economic development which- in the industrial- ized countries - virtually eliminated infectious diseases in recent history. Visionary initiatives like the CVI can have an enormous impact on human development within this larger picture. • Mr Frank Hartvelt is Deputy Director of the Division for Global and lnterregional Pro- grammes, United Nations Development Programme (UNDP), One United Nations Plaza, New York, NY 10017, USA.