1. be able to provide the leadership in conducting U.S. malaria vaccine development efforts and in coordinating these with international academic researchers, corporations, and relevant organizations such as the World Health Organization, the World Bank, the United Nations Development Programme, and the Commission of the European Communities.

While there are historical precedents for aspects of the proposed Malaria Vaccine Development Board, none completely covers all of the facets described above. Some examples of precedents that may be examined for relevance to specific elements of the board's charge include the 1941 Commission on Influenza of the Armed Forces Epidemiology Board, the National Task Force on AIDS Drug Development, and the National Foundation for Infantile Paralysis.

The board's development strategy should incorporate the action steps required for accelerated, cost-effective production, evaluation, and field application of the two malaria vaccines. The estimated costs of such a program and the optimal mix of governmental, academic, industrial, and foundation participation and support required should also be determined. In these determinations the board must clearly document the scientific foundation for any recommendations. In addition, because a major incentive for industrial investment in vaccine development is the size of the potential market for the vaccine, it is recommended that the board immediately commission independent market analyses for each of the proposed vaccine types, and that this information be made widely available to the global vaccine industry.

As a first step, it is recommended that the board consider convening a meeting of members to develop an agreement to ensure access to reagents in both the public and the private sector that could be useful in developing and conducting assays required to assess vaccine candidates in animals and humans. Such reagents should include, but not be limited to, purified recombinant proteins, synthetic peptides, live recombinant viruses and bacteria, DNA plasmids, and monoclonal antibodies. Having established strategies for sharing reagents equitably and consistently, the board could then address the more difficult goal of establishing productive, consensual alliances among government, academia, the nongovernmental sector, and industry for the purpose of rapid malaria vaccine development.

PREREQUISITES FOR SUCCESS

In order for the proposed Malaria Vaccine Development Board to be successful, effective leadership is necessary, and each participating entity must agree on the accepted strategy for vaccine development. This requires that each party identify areas of interest within the overall process, as well as areas of comparative advantage. Each entity should have a vested interest in sharing information and resources, and must find an economical method of doing so.



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