World Health Organization, Geneva, Switzerland.
Kingston upon Thames, United Kingdom.
Vaccine. 2020 Jul 6;38(32):4917-4923. doi: 10.1016/j.vaccine.2020.05.001. Epub 2020 May 4.
Enterovirus A71 (EV71) is one of the major causative agents of hand, foot and mouth disease (HFMD), and is sometimes associated with severe central nervous system syndromes. Vaccines against EV71 infection have been developed or are in development in several countries and few have been licensed in China. In response to requests from some of these countries, WHO convened a working group meeting in Shanghai China from 11 to 12 September 2019 to develop WHO Recommendations to assure the quality, safety and efficacy of EV71 vaccines. Meeting participants included members of the drafting group, experts from vaccine developers, manufacturers, regulators and academia. The epidemiology of EV71, as well as the development, regulation and standardization of EV71 vaccines were reviewed in the meeting. Information on R&D, manufacturing, quality control and standardization of EV71 vaccines was presented by vaccine developers, manufacturers and regulators. Based on their experience, the working group discussed the main principles that would determine WHO's position on quality, safety and efficacy of EV71 vaccines. The working group agreed to develop WHO Recommendations to assure the quality, safety and efficacy of inactivated EV71 vaccines with a scope covering only whole virus inactivated vaccines. Other type of vaccines, such as EV71 virus-like particles (VLPs) will not be covered as they are still at the developmental stage. The outline of the document was agreed and will follow the usual style of WHO recommendations. It was also agreed to submit the draft Recommendations for review and adoption to the WHO ECBS in 2020 following discussion at a WHO informal consultation, which will include NRAs and vaccine manufacturers.
肠道病毒 A71（EV71）是手足口病（HFMD）的主要病原体之一，有时与严重的中枢神经系统综合征有关。一些国家已经开发或正在开发针对 EV71 感染的疫苗，其中少数在中国获得许可。为响应其中一些国家的请求，世卫组织于 2019 年 9 月 11 日至 12 日在中国上海召开了一次工作组会议，制定世卫组织建议，以确保 EV71 疫苗的质量、安全性和效力。会议参与者包括起草组成员、疫苗开发商、制造商、监管机构和学术界的专家。会议审查了 EV71 的流行病学以及 EV71 疫苗的开发、监管和标准化。疫苗开发商、制造商和监管机构介绍了关于 EV71 疫苗的研发、制造、质量控制和标准化的信息。根据他们的经验，工作组讨论了确定世卫组织对 EV71 疫苗质量、安全性和效力立场的主要原则。工作组同意制定世卫组织建议，以确保仅涵盖全病毒灭活疫苗的灭活 EV71 疫苗的质量、安全性和效力。其他类型的疫苗，如 EV71 病毒样颗粒（VLPs），由于仍处于开发阶段，不在涵盖范围内。文件大纲已达成一致，并将遵循世卫组织建议的通常风格。还同意在世卫组织非正式磋商中进行讨论后，于 2020 年向世卫组织执委会生物标准部提交建议草案供审查和通过，磋商将包括国家监管机构和疫苗制造商。
