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The Children's Vaccine Initiative: Achieving the Vision
funds to existing federal agencies to support CVI-related vaccine research and development and would have made changes in the way that the U.S. government participates in the purchase and delivery of vaccines for developing countries; another would have given the U.S. government a primary role in all stages of vaccine development, including large-scale manufacture and distribution. Although each approach was thought to have some merits, the committee felt that neither would capitalize on the unique skills, expertise, and capabilities in the private sector (both biotechnology firms and commercial vaccine manufacturers). In the committee's view, the success of U.S. participation in the CVI will depend ultimately on effective cooperation and collaboration among government, universities, and most critically, the private sector. The committee's recommended strategy, which is presented below, combines the most desirable characteristics of the two strategies outlined above and includes new elements designed to achieve the vision of the CVI.
A NATIONAL VACCINE AUTHORITY
In the committee's view, the United States, through both the public and private sectors, has the potential to contribute most significantly to the achievement of the goals of the global CVI through the development and production of CVI vaccines (Chapters 3 and 4). However, it has become clear to the committee that the fragmented system of vaccine research, development, and manufacture in the United States, which produces high-quality vaccines for the domestic market, is not likely to produce the vast majority of CVI vaccines (Chapters 3, 4, and 5) (Institute of Medicine, 1992). This is primarily because most CVI vaccines targeted to developing countries lack the market potential of vaccines intended for industrialized-country markets (Chapters 4 and 5). In this regard, the committee concurs with the findings of the Institute of Medicine report, Emerging Infections (1992) that an integrated process is required to ensure that needed vaccines that lack well-paying markets are developed and manufactured. In addition and over the course of this study, the committee identified a number of specific impediments that hinder the ability of the U.S. public and private sectors to pursue the development of vaccines in general, and of CVI vaccines in particular (Chapter 6). In the committee's view, a major bottleneck in the development of low-profit vaccines, such as those envisioned by the CVI, is the lack of pilot production facilities that are capable of meeting the U.S. Food and Drug Administration's standards of current Good Manufacturing Practices (Chapter 6). At present, pilot manufacture of vaccine products of low commercial value is postponed for