Recommendations for the Use of Vaccines Manufactured with Bovine-Derived Materia

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From

Morbidity & Mortality Weekly Report (MMWR)

Notice to Readers: Public Health Service Recommendations for the Use of

Vaccines Manufactured with Bovine-Derived Materials

[MMWR 49(50):1137-1138, 2000. Centers for Disease Control]

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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 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.

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* 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.