Document Detail

Bovine sera used in the manufacture of biologicals: current concerns and policies of the U.S. Food and Drug Administration regarding the transmissible spongiform encephalopathies.
MedLine Citation:
PMID:  10404874     Owner:  NLM     Status:  MEDLINE    
Since 1993, consistent with its statutory responsibility to ensure that regulated products are safe, pure, and free of << extraneous organisms, >> the United States Food and Drug Administration (FDA) has requested that, with certain exceptions, bovine-derived materials from animals born in or residing in countries where bovine spongiform encephalopathy has occurred, should not be used to manufacture products intended for humans. FDA's Center for Biologics Evaluation and Research (CBER) has specifically recommended that serum used to produce biologicals be obtained from sources << certified to be free from contaminants and adventitious agents, such as the agent responsible for the production of Bovine Spongiform Encephalopathy. >> The United States Department of Agriculture (USDA) has prohibited importation of such serum for use in products. FDA staff are aware that bovine blood, including foetal blood, and placental tissues and fluids that might contaminate foetal serum have not been found to contain the infectious agent of BSE, and that those tissues are considered by most authorities to have little risk for transmitting disease to humans or animals. However, studies of BSE have been limited in size and sensitivity, and several experimental studies of scrapie and CJD in rodents found their blood to be infectious. In addition, a recent unpublished study of BSE (requiring confirmation) reported finding infectivity in the bone marrow of cattle. Possible transmission of BSE from cows to calves, although unlikely to constitute a major mode for maintaining the BSE outbreak, has also not been rigorously ruled out. Considering the special nature of biological products, especially of vaccines intended for widespread use in children, it seems prudent for U.S. regulatory authorities to continue current conservative policies that discourage or prohibit the use of bovine serum from countries with BSE.
D M Asher
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Developments in biological standardization     Volume:  99     ISSN:  0301-5149     ISO Abbreviation:  Dev. Biol. Stand.     Publication Date:  1999  
Date Detail:
Created Date:  1999-08-31     Completed Date:  1999-08-31     Revised Date:  2005-11-16    
Medline Journal Info:
Nlm Unique ID:  0427140     Medline TA:  Dev Biol Stand     Country:  SWITZERLAND    
Other Details:
Languages:  eng     Pagination:  41-4     Citation Subset:  IM    
Laboratory of Method Development, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852-1448, USA.
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MeSH Terms
Biological Products / standards*
Cattle Diseases / transmission*
Creutzfeldt-Jakob Syndrome / prevention & control
Encephalopathy, Bovine Spongiform / transmission*
Risk Assessment
United States
United States Food and Drug Administration*
Zoonoses / transmission
Reg. No./Substance:
0/Biological Products

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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