The Center for Biologics Evaluation and Research (CBER), FDA regulates biological products including vaccines. For several years CBER has recommended that bovine derived components from countries which have or may have BSE (bovine spongiform encephalopathy, the so called "mad cow disease") not be used for the manufacture of US-licensed biological products including vaccines. The consumption of food contaminated with the BSE agent has been linked to a fatal disease in people called new variant or variant CJD (vCJD). There is no evidence that any case of vCJD has resulted from use of a vaccine, and there is no evidence that any vaccines harbor the BSE agent. In 2000, CBER determined that some vaccines were manufactured using bovine components from countries which the USDA has determined have or may have BSE. CBER believed that the chance of getting vCJD through vaccines is remote and theoretical. However, CBER has responsibility to ensure that vaccines used in the US are safe and asked for this special joint meeting to ask vaccine and TSE experts to formally discuss the risk of transmitting vCJD from vaccines. | 
