National Institute of Biological Standards and Control, Potters Bar, England, UK.
Vaccine. 2010 Dec 6;28(52):8236-45. doi: 10.1016/j.vaccine.2010.10.070. Epub 2010 Nov 4.
In May 2009, WHO convened a meeting of Working Group on Technical Specifications for Manufacturing and Evaluating Yellow Fever (YF) Vaccines, Geneva, Switzerland to initiate revision of the WHO Recommendations (formerly, Requirements) for YF vaccine published in WHO Technical Report Series number 872 (1998). The Working Group, consisting of experts from academia, industry, national regulatory authorities and national control laboratories, reviewed the latest issues of safety, efficacy and quality of YF vaccines and agreed that (i) the revision should focus on live attenuated YF vaccine virus 17D lineage; and that (ii) nonclinical and clinical guidelines for new vaccines prepared from 17D lineage be developed.
2009 年 5 月,世卫组织在瑞士日内瓦召集了一个制造和评估黄热病(YF)疫苗技术规格工作组会议,以启动对世卫组织技术报告系列第 872 号(1998 年)中发布的 YF 疫苗世卫组织建议(原要求)的修订。该工作组由来自学术界、工业界、国家监管机构和国家控制实验室的专家组成,审查了 YF 疫苗的最新安全性、效力和质量问题,并同意(i)修订应集中在减毒活黄热病毒 17D 系上;以及(ii)应制定来自 17D 系的新型疫苗的非临床和临床指南。