Abstract

The Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA) learned earlier this year that some vaccines were manufactured with bovine-derived materials obtained from countries in which bovine spongiform encephalopathy (BSE) or a substantial risk for BSE exists. A list of these countries is published by the U.S. Department of Agriculture (USDA). This information was of concern because cases of variant Creutzfeldt-Jakob disease (vCJD) have been attributed to, among other possibilities, eating beef products from cattle infected with the agent of BSE. No evidence exists that cases of vCJD are related to the use of vaccines, and no cases of vCJD have been reported in the United States.

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