Accelerating Availability of New Vaccines: The Role of the International Community
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0092-8615/98 Copyright 0 1998 Drug Information Association Inc.
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ACCELERATING AVAILABILITY OF NEW VACCINES: THE ROLE OF THE INTERNATIONAL COMMUNITY* JULIE B. MILSTIEN,PHD Scientist
AMIE BATSON,MBA Technical Officer Vaccine Supply and Quality Unit, Global Programme for Vaccines and Immunization, World Health Organization, Geneva, Switzerland
Most vaccines available to national immunization programs rely on old technologies, are produced by a wide range of laboratories, and meet a variety of staandards. The world, however, is facing an explosion of new vaccine products and technologies. The challenge facing the international community is tofacilitate global access to high quality, affordable vaccines against priority diseases. Strategies developed to address this challenge are targeting assistance to the neediest countries, tiering of prices for new vaccines according to a segmented market, and assuring access to new technologies for viable local producers. The international community may intervene in three major areas: vaccine development, introduction, and self-sufficiency. Necessary activities include prioritization of vaccine options based on epidemiological disease burden, coordinating research and development, minimizing risks and costs of clinical trials, and strengthening infrastructure so that countries can take responsibilityfor their own vaccine supply needs. The indication that these activities are being effectively managed is the degree to which new vaccines against important diseases are available in all countries for the majority of the population at risk. Key Words: Vaccine development; Immunization; Harmonization; Vaccine markets; Vaccine financing
INTRODUCTION: PREVENTING DISEASE THROUGH IMMUNIZATION SINCE ITS BEGINNING IN 1974, the Expanded Programme on Immunization (EPI)
has aimed to assure protection against six core vaccine-preventable diseases. National immunization programs now reach more than 80% of the world’s children. Poliomyelitis is being eradicated, measles is being controlled, and the incidence of pertussis, tetanus, and diphtheria has fallen. But much more can be *Many of the ideas and recommendations in this article done. Figure 1 shows the number of deaths were discussed and debated at a meeting, “The Global prevented by vaccination and gaps which can Supply of New Vaccines,” co-sponsored by the Children’s Vaccine Initiative, and the Rockefeller Founda- be filled by better use of existing vaccines and development of new vaccines. tion, February 3-7, 1997, Bellago, Italy. Presented at the DIA 33rd Annual Meeting “OptiThe left side of the figure represents mizing Pharmaceutical Development: The Global Ex- smallpox, the eradication of which prevents perience,” June 22-26, 1997, Montreal, Canada. millions of deaths every year. In the middle Reprint address: Julie B. Milstien, PhD, Scientist. Vaccine Supply and Quality Unit, Global Programme for section are the diseases now targeted in the Vaccines and Immunization, World Health Organization,
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