• Without a major initiative in research, development, production, and procurement capability, new vaccines and new combinations will be used exclusively in economically advantaged countries, while less advantaged countries will remain dependent on the current Expanded Program on Immunization (EPI) vaccines and on the local production of vaccines.

  • It is insufficient just to develop new and improved vaccines; such vaccines must be manufactured and made available to the CVI and EPI.

  • U.S. pharmaceutical firms are profit-driven; their continued presence in vaccines depends on adequate returns on their investments.

  • The availability of vaccines in the United States depends almost entirely on incentives to commercial firms to develop and produce them.

  • Over 80 percent of the world's children are born in countries producing one or more of the EPI vaccines and almost 60 percent of diphtheria and tetanus toxoids and pertussis vaccine used in the world today is produced in the country that uses it.

  • U.S. inner-city and rural populations face vaccine delivery and coverage problems similar to those being addressed by CVI, and many CVI goals are compatible with national interests.

STRATEGY 1: RETAIN THE CURRENT SYSTEM

It is entirely possible that the current vaccine system, which has many strengths, could be augmented sufficiently to permit full U.S. participation in the CVI. The process of vaccine innovation in the United States, involves numerous organizations in both the public and private sectors. In contrast, the actual production of vaccines depends on a handful of commercial and two state manufacturers.

Under the current system, commercial manufacturers pursue the development of vaccines for which there is perceived to be adequate returns on investment. For the most part, commercial vaccine manufacturers cannot justify their investment either in the development of new vaccines or in the improvement of existing vaccines intended for predominately developing-country markets. Some priority CVI vaccines have limited industrialized-country markets and are therefore perceived to be unprofitable. The two largest buyers of vaccines internationally, the Pan American Health Organization (PAHO) and the United Nations Children's Fund (UNICEF), have procured vaccines for many years at very low prices. Given that no new vaccines have been developed and introduced to the UNICEF/PAHO/EPI market since its inception, it would appear that the prices quoted to UNICEF/PAHO are not sufficient to stimulate vaccine innovation.

Within the current system, small and medium-sized biotechnology



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