able in several states because of the sole source manufacturer’s inability to meet demand. Only one source is currently available for meningococcal varicella and measles-mumps-rubella vaccines.

There are just four major vaccine manufacturers in the world today, and only two in the United States [3]. There were four times that number only 20 years ago. There are many small new research and development companies backed by venture capital and devoted to vaccine development. Many are working on anticancer vaccines for which market forces may be enough to keep them in production. However, good products developed by these startups to combat infectious diseases often do not come to market because of the very large costs of testing in pilot studies and in manufacturing. Currently, the United States has a single licensed anthrax vaccine product, manufactured by a single plant. Because the Food and Drug Administration (FDA) had identified problems in the manufacturing process during regular inspections, the plant was closed for renovations in 1998, and to date, no new lots of anthrax vaccine have yet been cleared for release.

Prior to the events of September 11, the delays and problems faced by both the Department of Health and Human Services and Department of Defense in developing and procuring a cell-culture smallpox vaccine provide convincing evidence that major changes are needed at the national level. With the government guaranteeing payment in this time of national need, several potential manufacturers have come forward. This is an ad hoc example of a larger national need for mechanisms to obtain other public-good vaccines on an ongoing basis, and not just under extenuating circumstances when there is a great deal of public awareness of the need for vaccines.

The Children’s Vaccine Initiative committee listed the functions of a National Vaccine Authority as shown in Appendix 1. While these activities focused on the Children’s Vaccine Initiative, they now have a broader importance to America, as the potential need for vaccines required to meet biological threats increases. The IOM Council believes the Authority should focus its attention upon vaccines that will not be adequately produced by existing public or private entities. Important functions of the Authority would include: conducting inhouse vaccine-related research and development, assisting companies in the production of pilot lots of vaccines; and arranging and contributing to the procurement of National Vaccine Authority vaccines. An especially important function would be to provide opportunities for the production of pilot lots of vaccines developed by small biotechnology firms, and to produce vaccines when market forces are not sufficient to facilitate large-scale production.

The IOM Council further believes the Authority should facilitate communications among relevant contributors to vaccine research and development, including academic research efforts, manufacturers, regulatory agencies, and the public. The Authority should not interfere in any way with public or private research or development efforts to create new vaccines. It should be available to



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