Notice to Readers: Public Health Service Recommendations for the Use
of Vaccines Manufactured with Bovine-Derived Materials
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.
† References to sites of non-CDC organizations on the World-Wide Web are provided as
a service to MMWR readers and do not constitute or imply endorsement of these
organizations or their programs by CDC or the U.S. Department of Health and Human Services. CDC is
not responsible for the content of pages found at these sites.
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