developing countries and provides grant support for epidemiology and field testing.
In 1992, AID initiated a set of specific responses to the international Children's Vaccine Initiative (CVI) (U.S. Agency for International Development, 1992). These included a grant program to support research on CVI-related topics conducted jointly by scientists from the United States and less-developed countries. AID also has provided funding for the Vaccine Independence Initiative, sponsored by the United Nations Children's Fund (see International Resources, below).
The Center for Biologics Evaluation and Research at FDA is responsible for the scientific review of license applications for new biologics, including vaccines. CBER examines new biologics submitted by vaccine manufacturers for safety and efficacy, as well as process consistency and regulatory compliance. In addition to its role in licensing vaccines and facilities that manufacture vaccines, CBER has active laboratory research and postmarketing surveillance programs that complement and support its regulatory activities. CBER also works closely with scientific committees at the World Health Organization (WHO) and is working toward greater international harmonization of vaccine standards.
In fiscal year 1992, CBER had a total of 641.3 full-time equivalent positions (FTEs) (Center for Biologics Evaluation and Research, Office of Management, 1993). The operating budget was $24,365,000, and the payroll, including salaries and benefits, was $36 million (Center for Biologics Evaluation and Research, Office of Management, 1993). The number of FDA FTEs engaged in vaccine activities was 223, and FDA allocated over $27 million to CBER's vaccine work (Center for Biologics and Evaluation Research, Office of Management, 1993), $14.9 million of which was directed toward research and development for children's vaccines (World Health Organization/Children's Vaccine Initiative, 1993). CBER has also received support from the National Vaccine Program Office (NVPO) (U.S. Department of Health and Human Services, 1992). In fiscal year 1991, the NVPO provided eight FTEs and almost $1.9 million to FDA, permitting the agency to enhance the development of a safer pertussis vaccine, establish a computer tracking system to analyze the lot-specific relationships of reports of adverse events, and work on projects associated with the CVI (Kessler, 1992; U.S. Department of Health and Human Services, 1992).
FDA representatives actively participate on WHO technical and expert committees, which review and set international technical standards for