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J Infect Dis. 1997 Dec;176 Suppl 2:S189-91.

Regulatory considerations for Campylobacter vaccine development.

Author information

1
Division of Bacterial Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland 20892, USA.

Abstract

The high, worldwide incidence of Campylobacter jejuni-associated diarrheal disease has recently prompted the development of anti-Campylobacter vaccines. However, the association of C. jejuni infections with subsequent development of Guillain-Barré syndrome has increased concerns from a pathogenesis standpoint and from a vaccine development and regulation standpoint. This brief overview describes the purpose and process of Food and Drug Administration review of vaccine products and highlights some important considerations pertinent to Campylobacter vaccine development.

PMID:
9396709
DOI:
10.1086/513797
[Indexed for MEDLINE]

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