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Institute of Medicine (IOM) report on priorities for vaccine development, vaccines can now be envisioned for the treatment and prevention of diseases not previously considered to be potential vaccine targets: for example, therapeutic vaccines for noninfectious diseases such as multiple sclerosis and melanoma were absent from consideration in the 1985 exercise, and in the future, preventive vaccines for these diseases will also likely be studied. The role of hepatitis B virus in liver cancer was recognized in 1985, but the current report includes many more examples of vaccine-preventable infections as causes of chronic conditions; for example, hepatitis C virus infection and liver damage, including cancer; Helicobacter pylori infection and gastric ulcers and cancers; and human papillomavirus infection and cervical cancer. Furthermore, scientific studies are emerging indicating a role for infectious agents in the pathogenesis of coronary artery disease and in a predisposition to asthma.

Stable and sufficient funding of basic research by the federal government, the use of creative funding mechanisms, and the creation of alliances between the public and private sectors are crucial to ensuring that effective, safe, and needed vaccines will be carried through the development stage into licensure. Funding of basic research in fields such as immunology, virology, and micro-biology can also lead young investigators into more applied research on vaccines. In addition to basic research in molecular and cellular biology, progress in vaccine development and program implementation depends on research in fields such as epidemiology, health services research, health economics, human behavior, and even ecology. The lack of data and research in these fields, information that would have been useful to the committee in assessing disease burden, was surprising. In some cases, no significant new data had been published since that referenced in the 1985 IOM report on vaccine priorities, particularly national data on disease characteristics such as morbidity states and patterns of care.

R&D is an expensive enterprise currently supported through a natural and fluid mix of public and private funding. The federal funds used to support intramural research within government laboratories or dispensed by the extramural programs to researchers, most of whom are in academic institutions, have traditionally supported the vast majority of basic science research. New knowledge resulting from basic research is the essential first step that allows applied R&D to move forward into the private sector. Chapter 3 discusses how the lack of fundamental understanding of immune responses to Treponema pallidum, for example, led the committee to not consider the development of a vaccine against this agent, which is the cause of a very important public health problem, syphilis. Although it is sometimes difficult to demonstrate the benefits of investment in basic research with a direct link to a health intervention, the reader is referred to a classic paper for examples (Comroe and Dripps, 1976).

The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) provides the majority of the approximately $250 million of public money spent annually on vaccine research (Mercer Management Consulting, 1995). Much of this is investigator-initiated basic research.

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