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The Children's Vaccine Initiative: Achieving the Vision
months or even years in commercial facilities, while the small number of public-sector facilities remain oversubscribed.
In the committee's judgment, the optimal way to maximize U.S. public-and private-sector participation in the global CVI and ensure that needed vaccines are developed and manufactured for developing countries is to empower an entity to organize and manage an integrated process of CVI vaccine development, manufacture, and procurement that capitalizes on the skills and expertise in both sectors. At this time, no federal entity, with the possible exception of the U.S. Department of Defense, has the capability of undertaking the breadth and range of activities required to ensure the integrated development, production, and procurement of CVI vaccines. In the committee's view, the development of new and improved CVI vaccines is unlikely to occur unless there is an entity that has the mandate to manage and oversee the process from beginning to end. Because the private sector alone cannot sustain the costs and risks associated with the development of most CVI vaccines, and because the successful development of vaccines requires an integrated process, the committee recommends that an entity, tentatively called the National Vaccine Authority (NVA), be organized to advance the development, production, and procurement of new and improved vaccines of limited commercial potential but of global public health need.
As envisioned by the committee, the overall mission of the NVA would be to foster the development of new and improved vaccines of limited commercial potential but global public health need through the maximal use of U.S. public- and private-sector expertise and resources. It would do this both by reducing the risks and costs to industry associated with vaccine development and by offering a variety of incentives to companies willing to undertake CVI vaccine development. The NVA would achieve its goals through a dynamic partnership with the public and private sectors, in which each contributes what it is best able and most willing to provide. The new entity would take advantage of the traditions of discipline and attention to the bottom line that are common to private industry and the accountability to societal needs embodied in the public sector.
To accomplish its mission, the NVA would operate as a product development unit. In conjunction with the global CVI, it would be involved in setting the priorities for and generating the desired characteristics of candidate CVI vaccines. The NVA would issue requests for proposals to