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U.S. public health burden was less compelling than inclusion of other candidate vaccines, and might fall into Level IV. An analysis of international disease burden for these candidate vaccines would likely lead to results that fall into more favorable levels.

OBSERVATIONS

In the course of developing and illustrating this model, the committee discussed general issues relating to the funding of research, neglected opportunities for vaccine research and development, the qualitative judgments integral to this modeling exercise, and vaccine program concerns. The committee closes the report with a series of observations that it hopes are as seriously considered as the analytic model that was the focus of this project.

Stable and sufficient funding of basic research by the federal government (which has an added benefit of recruiting young investigators from all fields of biomedical science into vaccinology), as well as creative funding mechanisms and research alliances, are crucial to assure that effective, safe, and needed vaccines will be carried through the development stage into licensure. Research and development is an expensive enterprise currently supported through a natural and fluid mix of public and private funding. New knowledge resulting from basic research funded by the federal government and private foundations is the integral first step that allows applied research and development to move forward into the private sector. Although private industry supports basic research, the most important role it plays is to assume the costs of applied research and development.

The committee can envision situations, however, where the need for a vaccine is compelling but for which the return on investment cannot be guaranteed. Examples of impediments to making a profit include possible litigation, a small target population, lack of acceptance of a vaccine strategy for a specific condition, and high costs expected of newer vaccines. Sometimes the market fails, and without subsidization candidate vaccines become neglected.

The committee discussed other barriers to achieving the maximum health benefit from the candidate vaccines. Vaccine delivery poses significant barriers to effective prevention and control of infectious disease. Children in the United States can receive up to 6 different vaccines (adding up to a maximum of 32 antigens, 6 visits to a health care provider, and 16 injections) before 2 years of age. Compliance with recommended immunizations by 2 years of age is still below that achieved by 5 years of age, primarily because of mandatory immunization for school entry. Combination vaccines promise to reduce some of the barriers to compliance but will not be a panacea. The combinations will help increase acceptance and utilization of vaccines, but clinical trial design issues are not trivial. The committee hopes that government, the medical community, the public, and vaccine manufacturers carefully think about rational approaches to combination vaccines and vaccine schedules. Furthermore, noninjection



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