title: Biosafety evaluation of recombinant live oral bacterial vaccines in the context of European regulation.
abstract: Live bacterial vaccines represent a highly valid preventive strategy in the fight against infectious disease. However, the road from research to market is peppered with hurdles, one of which is the requirement for high biosafety characteristics, which the candidate vaccine has to display. In Europe, the European Agency for the evaluation of medicinal products (EMEA) is the relevant authority regulating the licensure of genetically engineered vaccines. For this purpose, the agency may rely on several directives and guidelines defined in the past 15 years. As for live vaccines containing genetically modified organisms (GMOs) susceptible to be released into the environment, Directive 2001/18/EC determines the framework and principles of an environmental risk assessment (ERA) process, the results of which constitute an important section of the vaccine registration package submitted to registration authorities. In this article, we address the implications of current European regulations for the approval of live oral bacterial vaccines with emphasis on the assessment of potential risks associated with environmental release. Biosafety aspects of already registered and some promising live bacterial vaccine strains will be briefly discussed.
authors.affiliation: Berna Biotech Ltd., Research Rehhagstrasse 79, 3018 Berne, Switzerland.
authors.forename: Didier
authors.initials: D
authors.lastname: Favre
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Viret
mesh_terms: D001428:Bacterial Vaccines / Q000009:adverse effects / Q000235:genetics / Q000276:immunology; D022121:Cholera Vaccines / Q000009:adverse effects / Q000235:genetics / Q000276:immunology; D017277:Drug Approval; D004335:Drug and Narcotic Control; D064420:Drug-Related Side Effects and Adverse Reactions; D005060:Europe; D006801:Humans; D030781:Organisms, Genetically Modified; D018570:Risk Assessment; D022281:Shigella Vaccines / Q000009:adverse effects / Q000235:genetics / Q000276:immunology; D012763:Shigella flexneri / Q000235:genetics / Q000276:immunology; D014436:Typhoid-Paratyphoid Vaccines / Q000009:adverse effects / Q000235:genetics / Q000276:immunology; D014613:Vaccines, Attenuated / Q000009:adverse effects / Q000235:genetics / Q000276:immunology; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000235:genetics / Q000276:immunology
chemical_list: D001428:Bacterial Vaccines; D022121:Cholera Vaccines; D022281:Shigella Vaccines; D014436:Typhoid-Paratyphoid Vaccines; D014613:Vaccines, Attenuated; D014614:Vaccines, Synthetic