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by the influence of media coverage (e.g., pertussis vaccine acceptance in the United Kingdom)

These factors affect each other in ways that are not fully understood or quantifiable. In its report on vaccine priorities for important diseases in the United States, this committee considered the issues of vaccine availability and utilization separately (Institute of Medicine, 1985a). A similar approach has been adopted for this project because factors affecting availability and utilization in the developing world are different. In addition, for some vaccines considered in this assessment, there may not be a need for universal availability or utilization.

VACCINE AVAILABILITY

Availability of a licensed vaccine depends on the willingness of a pharmaceutical company or other entity to manufacture it and on the company’s ability to produce the vaccine in sufficient quantities to meet demand. Factors influencing a pharmaceutical company’s willingness to manufacture a vaccine include:

  • profitability in public or private sale, which is affected by market size and composition (e.g., ability to pay), public health initiatives, patentability or status as sole supplier, and provider and lay acceptance

  • legal concerns, particularly costs associated with vaccine injury compensation liability, which is a major issue in the United States

  • technical difficulty of production and of distribution (in a manner that ensures potency) in target areas

  • humanitarian and public relations issues

Probably some of the vaccine candidates considered in this analysis will not be commercially attractive to manufacturers in the United States or other industrialized countries, and they eventually will be made locally in developing countries. The committee had insufficient information to predict the availability of new vaccines,* so it assumed that any vaccine that met reasonable safety and efficacy standards (e.g., U.S. licensing standards or World Health Organization [WHO] guidelines) would be available in quantities sufficient to meet the demand. Such a scenario would probably require the transfer of vaccine

*  

The Committee on Public-Private Sector Relations in Vaccine Innovation, Institute of Medicine, recently made recommendations designed to encourage public-private sector collaboration in the development and manufacture of vaccines, particularly those of low commercial potential (Institute of Medicine, 1985b).



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