• Coccidioides immitis vaccine to be given to resident infants born in and immigrants of any age of geographically defined high-risk areas,

• enterotoxigenic Escherichia coli vaccine to be given to infants and travelers,

• Epstein-Barr virus vaccine to be given to 12-year-olds,

• Histoplasma capsulatum vaccine to be given to resident infants born in and immigrants of any age of geographically defined high-risk areas,

• Neisseria meningitidis type b vaccine to be given to infants, and

• Shigella vaccine to be given to infants and travelers or to travelers only.

Several of the Level I candidate vaccines were also discussed in the 1985 IOM report on vaccine prioritization. The disease burden of the four infectious conditions in Level I remains staggering due to many factors: the numbers of infected people, the seriousness of the health states caused by the infection, and the long-term sequelae (death and permanent impairment) and subsequent loss of quality of life (as measured in QALYs). The inclusion of candidate vaccines that are therapeutic suggests that vaccine strategies for noninfectious, chronic conditions holds much promise for improving health.

The inclusion in Levels I and II of candidate vaccines to be administered in puberty should serve as an indication for planning by vaccination program implementers for new approaches to encouraging the use of vaccines. The appropriate use of these candidate vaccines will require acceptance by parents, children, and health care providers that all people entering puberty are potentially sexually active. This also will require a health care milieu that is more capable than it is now of routine vaccination at puberty. Factors such as health beliefs, health care practices, performance measurements for health plans, and school entry laws have contributed to relatively successful childhood immunization efforts. These do not yet exist for the newly emerging “adolescent” or “pubertal” vaccination visits that are now recognized as important for continued protection against measles and rubella, for example.

Another challenge will be immunization of pregnant women against Group B streptococcus. The report discusses the barriers, particularly legal barriers to developing vaccines to be administered during pregnancy. The model assumes that these barrier are overcome and that immunization of pregnant women can become a standard part of prenatal care.

As stated several times in the report, the committee has not recommended which vaccines should be accorded development priority, nor will it recommend which vaccines should not be developed. Research and development of Level IV candidate vaccines can be justified on several levels. Research on these vaccines can lead to fundamental discoveries important to other candidate vaccines in the future or to other areas of basic research. Disease patterns could change and a need for these vaccines could become more compelling. These vaccines could be important due to disease burden in other countries, which is not factored in as part of this analysis. The committee argues in the report that inclusion of a candidate vaccine for malaria or dengue hemorrhagic fever in a report analyzing