has been done to integrate these considerations of fairness into cost-benefit or cost-effectiveness measures. To the extent that cost-effectiveness measures sometimes conflict with fairness, such integration of considerations of fairness into the measures could amount to partial abandonment of the cost-effectiveness standard. Second, these issues of fairness remain controversial, and there is no clear consensus with which the committee could have justified building specific positions into our model.

For these reasons, it is common in studies like the committee’s to employ a cost-effectiveness analysis to develop a priority list, and then to remind policymakers who will make use of the list that they must, of course, also consider distributive issues of fairness or justice concerning the distribution of benefits and burdens in the ultimate priorities that they adopt. While the committee was unable, for the two reasons cited above, to integrate these issues of fairness or justice into the formal model, the committee does attempt to advance attention to these issues beyond what they typically receive by discussing briefly the nature of some of the more important considerations and illustrating where they arise in determining priorities for vaccine development.

Before discussing ethical issues in the development and use of the model for prioritization of new vaccine development, the committee wants to underscore one important ethical limitation that was imposed from the outset by the scope of work: the committee was asked to consider only the U.S. health needs of the population. In some cases this resulted in diseases with a very high burden of disease worldwide, such as malaria, cholera, and shistosomiasis, not even appearing on the final list of candidates that the committee included in the analysis. In other cases, vaccines for diseases that were considered might have received a very different ranking if our study had not been restricted to the U.S. population. It would have been a challenge beyond our resources and mandate to include an assessment of international disease burden as an additional quantitative factor in this model, and the committee did not undertake this.

Clearly, U.S. government agencies like National Institute of Allergy and Infectious Diseases and the other components of the National Institutes of Health are justified in giving priority to the needs of U.S. citizens whose tax dollars support their work. However, a wide variety of government-supported programs and activities, from direct foreign aid and overseas disaster relief programs to support for international peacekeeping, human rights, and third-world development efforts, are concerned with the well-being of the population beyond our borders and reflect our recognition of international responsibilities even if they sometimes serve U.S. interests as well. Especially in an area like medical research in general and vaccine development in particular, in which the United States has long been a world leader, the committee believes that ethically justified priorities for new vaccine development cannot ignore health needs beyond our own borders. Both governmental agencies and private organizations that make use of this report are urged not to ignore worldwide needs and opportunities for disease prevention from new vaccine development.