significant returns on investment, and companies are reluctant to invest in developing such high-risk and commercially unattractive products (see Chapter 5).

The committee believes that priority setting and characterization of desired vaccine products is a critical stage of vaccine development, particularly for vaccines of low commercial interest but acute public health need. In this regard, the committee urges all groups involved in vaccine R&D for international public health applications to focus on a common and complementary set of vaccine priorities.

BASIC AND APPLIED RESEARCH

The fundamental scientific advances that make vaccine development possible arise from basic research. The full implications and ultimate applications of discoveries made in the basic research laboratory may be unanticipated, even by the investigators involved. Basic research relevant to vaccine development includes such things as the identification and isolation of the protective antigens of a specific pathogen, methods for DNA cloning, the creation of new vector systems, and the development and immunologic evaluation of new adjuvant systems.

Basic research is conducted primarily by federally funded academic and government scientists. Once a basic scientific finding is thought to have significant and practical applications, the research moves on to applied R&D (the exploratory development phase). Much applied research and almost all product-development activity are conducted by private industry. Both biotechnology firms and vaccine manufacturers invest in developing new technologies to deliver and enhance the quality and efficacy of vaccines. Unfortunately, some CVI-specific vaccine technologies (e.g., heat stabilization of viral vaccines) are unlikely to be pursued by U.S. firms, because such technologies would have little comparative advantage in the domestic market. The committee believes that additional incentives can be provided to university-based researchers, commercial vaccine manufacturers, and biotechnology companies to stimulate the development of such technologies and their subsequent handoff from basic research to the product-development stages. Possible incentives are discussed in Chapter 7.

CLINICAL EVALUATION

Good vaccines must meet basic criteria of safety, purity, potency, and efficacy. When a product has completed preclinical studies (usually



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