companies are a new force in the pharmaceutical industry, contributing especially to the development of new and improved technologies for constructing vaccines. Few of these companies, however, have the capability to manufacture a vaccine on a pilot scale, and almost none have a full-scale manufacturing facility. To manufacture their products on a commercial scale, most biotechnology companies must form strategic alliances with larger pharmaceutical companies. Ultimately, then, the decision to make a vaccine rests entirely with large, private industry, which bases its activities on the perception of a commercial market.

Assuming no fundamental changes in the current system of vaccine innovation summarized above, the committee identified three possible approaches for enhancing U.S. participation in the CVI: substantial increase in financial support for CVI vaccine research carried out by government agencies, federal purchase of existing vaccines for use in programs such as the EPI, and improvement in the delivery of existing vaccines.

Option 1:
Increased Funding for CVI Vaccine Research

Under this option, substantial new funding would be added to the budgets of the various agencies involved in vaccine-related research. The additional money would supplement the investment in vaccine research at the National Institutes of Health (NIH), the U.S. Department of Defense (DOD), the U.S. Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC).

The main benefit of this option is a continued commitment to vaccine research in the public sector. In addition, increased resources would be directed toward vaccines that are most relevant to the CVI. However, this option does not encourage enhanced participation by private industry, neither biotechnology firms nor established manufacturers, and the superb resources that they could bring to the CVI. In this sense, it does not foster optimal participation in the CVI by the United States. Also, by simply increasing funds for the beginning stages of vaccine development, this option does not effectively overcome any of the obstacles in the current system that might impede the process of vaccine development and manufacture, most particularly the shortage of facilities used to produce pilot lots of vaccine. Finally, injecting additional resources into public-sector vaccine research would do little to increase the commercial viability of CVI vaccines; as a result, production of these vaccines would be unlikely.

For this option to materialize, an estimate of resource requirements would need to be made and the U.S. Congress would have to appropriate the additional funds. No other major changes in the status quo would be



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