Kopecko D J
Division of Bacterial Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland 20892, USA.
J Infect Dis. 1997 Dec;176 Suppl 2:S189-91. doi: 10.1086/513797.
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.
空肠弯曲菌相关腹泻病在全球的高发病率最近促使了抗空肠弯曲菌疫苗的研发。然而，空肠弯曲菌感染与随后吉兰-巴雷综合征的发生之间的关联，从发病机制角度以及疫苗研发和监管角度都增加了人们的担忧。本简要概述描述了美国食品药品监督管理局对疫苗产品的审查目的和过程，并强调了与空肠弯曲菌疫苗研发相关的一些重要考量因素。
