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caries. The basic and applied science of mucosal immunity will influence vaccine research for many candidate vaccines in the future. The committee did not include candidate vaccine for S. mutans in its analysis, but recognizes the incalculable benefit to basic science of current vaccine research in the area.

Therapeutic Vaccines

The inclusion of therapeutic vaccines directed against autoimmune diseases such as rheumatoid arthritis or multiple sclerosis is a departure from a traditional array of candidate vaccines. Because there are no licensed therapeutic vaccines, understanding of when health benefits could be realized in the course of disease with a vaccine strategy is incomplete. The varied pathophysiology of such diseases also leads to varying expectations regarding when they can be used effectively in the course of disease. It is possible that some therapeutic vaccines would provide effective treatment at later stages of disease, whereas other vaccines would be effective only in early stages. The committee assumed in its analysis that such vaccines are given near to the time of diagnosis; that is, in early disease stages.

Programmatic Considerations

An influential factor in the committee’s deliberations about the qualitative inclusion criteria, and in the analytic model, concerns implementation and utilization issues. The committee expects that the report can be useful to vaccine program implementers and policymakers, as well as for the research and development community. The committee has only included vaccines it believes can be important medical and public health tools. However, the committee is cognizant of the concerns of those who will need to plan for the use of the many vaccines that could be licensed in the next 20 years. The chapter concludes with a discussion of implementation issues for children, adults, and pregnant women.

Delivery of Vaccines to Children

The use of vaccines for infant and childhood immunization in the United States is a complex issue, with multiple factors influencing the success of the implementation of the schedules recommended by the Federal Advisory Committee on Immunization Practices and the Committee on Infectious Diseases (“Redbook Committee”) of the American Academy of Pediatrics (AAP). Many studies have investigated the reasons for poor compliance with these schedules and have provided greatly varying conclusions. Issues that are repeatedly en-



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