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.
CBER assessed the risk for vCJD from vaccines manufactured with processes that use bovine materials potentially contaminated with the BSE agent. On July 27, 2000, CBER convened a joint meeting of the Transmissible Spongiform Encephalopathy Advisory Committee and the Vaccines and Related Biological Products Advisory Committee to review the results of these assessments and make recommendations about the use and manufacture of these vaccines. The committees concluded that the risk for vCJD posed by vaccines in the scenarios presented was theoretical and remote. This conclusion was based on the inherent low risk of the bovine materials involved (e.g., type and amount of tissue[s] used, specific time and country, or herd of origin) and/or the dilutions of materials during manufacture. The committees concluded that the benefits of vaccination outweigh any remote risks for vCJD.
As a precautionary measure, the committees recommended that vaccines manufactured with bovine-derived materials from countries on the USDA list be replaced with bovine-derived materials from other countries. This recommendation, which is consistent with existing FDA guidance first issued in 1993 on the sourcing of bovine-derived materials, is intended to reduce even the remote risk for vCJD from vaccines. The committees also recommended that FDA provide information to the public about the safety of vaccines made with materials from countries in which BSE or BSE risk exists.
FDA has requested that manufacturers replace bovine-derived materials obtained from countries on the USDA list with materials obtained from countries not on the USDA list. All of the affected manufacturers have agreed to implement these changes or have already done so. FDA anticipates that most of these changes will be completed in 2001.
The Public Health Service (PHS) recommends that all persons continue to be vaccinated according to current schedules. PHS has no preference for using one licensed vaccine product over another based on the source of bovine-derived materials used in vaccine production. Failure to obtain the recommended vaccinations with licensed vaccines poses a risk for serious disease.
Additional information about BSE or vaccines manufactured with bovine-derived materials from countries on the USDA list can be obtained from the FDA World-Wide Web site, http://www.fda.gov/cber/BSE/BSE.htm , or from CBER's Office of Communications, Training and Manufacturers Assistance, telephone (800) 835-4709.
* 9 CFR, part 94.
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