that the development and manufacture of new and improved vaccines are critical to the health and welfare of children in the United States and abroad, it could be argued that the public sector should assume responsibility for public health needs that are not met by the private sector. (The Public Health Service Act of 1944 permits the government to produce vaccines and other products not available from licensed establishments [See Appendix E].)

A public-sector agency could take on every stage of the vaccine life cycle: set priorities, generate requirements for vaccines, conduct basic and applied research, and engage in product development, full-scale manufacture of vaccines, and delivery. A public-sector vaccine developer and manufacturer would be responsive to the public health needs of the U.S. population as well as to those of the developing world.

Vaccines manufactured by the public sector could be sold on a cost-plus basis to public health departments in the developing world, international agencies, and/or commercial distributors in developing countries. To use the vaccines for this purpose without being hindered by the cost of having to obtain licenses, the public sector must have a mechanism to ensure ownership of intellectual property rights of all antigens and technologies contained in the vaccines.

Despite the potential attractiveness of a vaccine manufacturer that would respond to unmet public health needs, the public sector does not have the experience in the large-scale manufacture of vaccines. In addition, efficient vaccine production does not lend itself to government procurement policies and bureaucracy, and this strategy does little to capitalize on the research, development, and manufacturing capabilites that already exist in the private sector. Furthermore, it may be politically untenable to commit such substantial U.S. government resources to products with no demand in the United States. Most importantly, however, this model does not take advantage of the unique skills and capabilities in the private sector, including both biotechnology firms and commercial vaccine manufacturers.

Contribution to the Global CVI

The U.S. government would develop and manufacture CVI vaccines and sell them to UNICEF and developing countries at an affordable price.

* * *

Over the course of the study, the committee considered each of the major strategies and options outlined above—their contribution to the global CVI

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