Kirk Dwayne D, McIntosh Kim, Walmsley Amanda M, Peterson Robert K D
The Biodesign Institute and School of Life Sciences, Arizona State University, Tempe, AZ 85287, USA.
Transgenic Res. 2005 Aug;14(4):449-62. doi: 10.1007/s11248-005-5697-3.
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.
1990年首次提出在转基因植物中生产疫苗，但至今尚无产品实现商业化。在该技术的生产和交付阶段存在若干风险，可能对环境和人类健康产生影响。对环境的风险包括基因转移以及接触抗原或选择标记蛋白。对人类健康的风险包括口服耐受性、致敏性、剂量不一致、工人接触以及食物链中意外接触抗原或选择标记蛋白。通过在潜在植物源疫苗生产和分发的各个阶段采取适当的监管措施，这些风险是可控的。这项技术的成功应用高度依赖于该技术开发者的管理和积极的风险管理，以及监管机构将制定的生产质量标准。监管机构也可能对该技术的未来可行性产生负面影响，比如要求控制所有风险，或者采用对植物生产和口服给药系统来说过于繁琐的传统法规。在考虑植物细胞生产并口服的新型或替代疫苗的价值时，必须兼顾其生产和使用中潜在风险的可能性和严重性，以及不采用这项技术的代价——维持现状的风险。
