title: Risk analysis for plant-made vaccines.
abstract: The production of vaccines in transgenic plants was first proposed in 1990 however no product has yet reached commercialization. There are several risks during the production and delivery stages of this technology, with potential impact on the environment and on human health. Risks to the environment include gene transfer and exposure to antigens or selectable marker proteins. Risks to human health include oral tolerance, allergenicity, inconsistent dosage, worker exposure and unintended exposure to antigens or selectable marker proteins in the food chain. These risks are controllable through appropriate regulatory measures at all stages of production and distribution of a potential plant-made vaccine. Successful use of this technology is highly dependant on stewardship and active risk management by the developers of this technology, and through quality standards for production, which will be set by regulatory agencies. Regulatory agencies can also negatively affect the future viability of this technology by requiring that all risks must be controlled, or by applying conventional regulations which are overly cumbersome for a plant production and oral delivery system. The value of new or replacement vaccines produced in plant cells and delivered orally must be considered alongside the probability and severity of potential risks in their production and use, and the cost of not deploying this technology--the risk of continuing with the status quo alternative.
authors.affiliation: The Biodesign Institute and School of Life Sciences, Arizona State University, Tempe, AZ 85287, USA. dwayne.kirk@asu.edu
authors.forename: Dwayne D
authors.initials: DD
authors.lastname: Kirk
authors.forename: Kim
authors.initials: K
authors.lastname: McIntosh
authors.forename: Amanda M
authors.initials: AM
authors.lastname: Walmsley
authors.forename: Robert K D
authors.initials: RK
authors.lastname: Peterson
mesh_terms: D000818:Animals; D001709:Biotechnology; D046508:Culture Techniques; D004304:Dosage Forms; D004784:Environmental Monitoring; D015386:Hazardous Substances / Q000592:standards*; D006801:Humans; D030821:Plants, Genetically Modified / Q000378:metabolism; D018570:Risk Assessment; D019076:Transgenes; D014481:United States; D016885:United States Department of Agriculture; D022462:Vaccines, Edible / Q000009:adverse effects* / Q000096:biosynthesis / Q000592:standards
chemical_list: D004304:Dosage Forms; D015386:Hazardous Substances; D022462:Vaccines, Edible