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.