title: Regulatory considerations for Campylobacter vaccine development.
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.
authors.affiliation: Division of Bacterial Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland 20892, USA.
authors.forename: D J
authors.initials: DJ
authors.lastname: Kopecko
mesh_terms: D001428:Bacterial Vaccines / Q000009:adverse effects; D002169:Campylobacter Infections / Q000517:prevention & control*; D016123:Campylobacter jejuni / Q000276:immunology*; D002986:Clinical Trials as Topic; D017277:Drug Approval; D006801:Humans; D011129:Polyradiculoneuropathy / Q000209:etiology / Q000517:prevention & control; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000592:standards
chemical_list: D001428:Bacterial Vaccines