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New Vaccine Development: Establishing Priorities, Volume II, Diseases of Importance in Developing Countries Appendix J Preface to Volume I Resource constraints in both the public and the private sector limit investment in vaccine research and development. The choice of options is complicated by large variations in the severity and duration of disease-related conditions, the existing knowledge base for new vaccine development, the time and resources required to bring the vaccine to licensure and the expected utilization. This report presents a comprehensive model designed to help government decision makers set priorities for vaccine development. It can be used to assess new vaccine candidates or to reassess current contenders as additional information becomes available. The history of this study extends back to the fall of 1980, when the Secretary of the Department of Health and Human Services (DHHS) accepted a recommendation by the DHHS Steering Committee for Development of a Health Research Strategy to establish a program of accelerated development for new vaccines. The purpose of the initiative, proposed by the National Institute of Allergy and Infectious Diseases (NIAID), was to develop within DHHS a coordinated approach to the further conquest of vaccine-preventable diseases. The first step toward implementation of the program was a three-day meeting in the fall of 1981 of the staff of NIAID’s Microbiology and Infectious Diseases Program. Participants reviewed the status of NIAID’s vaccine development effort, which included studies on more than 50 vaccine antigens for more than 30 bacterial, viral, fungal, and parasitic diseases. A tentative list of priorities was developed. One year later, NIAID contracted with the National Academy of Sciences for assistance in developing a more comprehensive approach to setting priorities for accelerated vaccine development. The Committee on Issues and Priorities for New Vaccine Development was established in the Institute of Medicine’s Division of Health Promotion and Disease Prevention. Careful selection of members produced a committee with the collective expertise necessary to conduct a study of this scope; research virologists, bacteriologists, physicians, economists, epidemiologists, sociologists, public health experts, and industry leaders all have made significant contributions to the final product. The committee was asked to develop a decision-making framework for selecting among vaccine candidates of importance to the U.S. population, and to use it to rank such candidates. it also was charged with
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New Vaccine Development: Establishing Priorities, Volume II, Diseases of Importance in Developing Countries evaluating the usefulness of the model in setting priorities for vaccines needed by technologically less developed nations, and with modifying the model as necessary to rank potential vaccines for international use. (The committee’s findings relative to the international aspects of vaccine development will appear in a second volume of this report.) Among the factors that NIAID requested be considered in developing the priority setting approach were: scientific and technical readiness opportunities for safety and efficacy testing socioeconomic impact, including the incidence, prevalence, severity, and cost of the target condition; and where feasible, the cost-effectiveness of potential vaccines social impact, including legal and ethical problems, patient and provider acceptance, special problems with certain populations (e.g., immunization of pregnant females or young infants), policy considerations (e.g., whether a program should be comprehensive and mandatory or selective and voluntary), and the respective roles of government and industry. The importance of industry-government relations in assuring a stable supply of existing vaccines and continued development of new ones has become increasingly clear over the past decade. There has been a decrease in the willingness of pharmaceutical companies to become involved in vaccine research, development, and manufacturing. There is, therefore, cause for concern that the supply of existing vaccines may be endangered and that technically feasible vaccines will not be manufactured and made available to the public. The reasons for these problems are complex and include economic, legal liability, and sociopolitical factors. An analysis of impediments and disincentives to vaccine innovation is being undertaken by the Institute of Medicine’s Committee on Public-Private Sector Relations in Vaccine Innovation. The current report touches on these issues only briefly as they relate to the controversy surrounding the existing pertussis vaccine (Chapter 8). The Committee on Issues and Priorities for New Vaccine Development would like to take particular note of the excellent support provided by the Institute of Medicine staff headed by Roy Widdus. The assistance of NIAID project officer C.David Wise is also gratefully acknowledged. Samuel L.Katz Chairman
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