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scribed in this report, it would be prudent to at least qualitatively consider the nature of the international burden of disease potentially averted by use of the vaccine outside the United States.

Small Target Populations

Some infections threaten the health of only a small group of people, but that threat is nevertheless quite serious for that population. Chapter 6 discusses ethical considerations and provides some insight into how this situation can be considered. These groups can be identified by geography, age, or chronic health conditions. The committee felt that a Pseudomonas aeruginosa vaccine was not necessarily compelling for the general population, but that the threat to the health of people with cystic fibrosis was severe. Although the committee did not analyze the cost-effectiveness of a candidate vaccine for P. aeruginosa, it recognizes the benefit to be gained from a vaccine for that targeted group of people. The committee did analyze the cost-effectiveness of a candidate vaccine against two conditions of relatively low incidence but serious morbidity. These are the geographically-confined infections of Histoplasma capsulatum and Coccidioides immitis. As the results demonstrate (Chapter 4), these candidate vaccines fall into Level IV, despite the very serious morbidity associated with these infections. One significant difference in the consideration of a candidate vaccine for P. aeruginosa compared to one for H. capsulatum or C. immitis is that the health status of the target populations is very different. The impaired baseline health status of the P. aeruginosa target population would affect the cost-effectiveness ratio in ways that are unfavorable. Equity considerations, such as those discussed in Chapter 6, might have an important qualitative influence on policy-making regarding development or use of a P. aeruginosa vaccine.

Liability Concerns

As described in other sections of the report, concerns about liability have influenced vaccine R&D over the past two decades. The creation of the Vaccine Injury Compensation Program (VICP) successfully stabilized and encouraged the development of vaccines primarily intended for use in children. However, many existing vaccines are not covered by that program. The lack of compensation or indemnity against liability is perceived as a serious impediment to the development of some new vaccines; in particular, vaccines that would be beneficial if given to pregnant women. Vaccine manufacturers and other researchers interested in the use of vaccines directed against group B streptococcus and other infectious agents believe that some form of legal protection from lawsuits is imperative before these vaccines can be developed and licensed. The rationale for the immunization of pregnant women as a crucial strategy for reducing the rates of morbidity and mortality from group B streptococcus in both mothers and

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