应对流感流行的疫苗准备:全球流感疫苗株更新机制和监管体系  

Vaccine preparedness for influenza pandemic:global influenza vaccine strain updates and regulatory system

作　　者：潘阳 鲁爽 Pan Yang;Lu Shuang(Office of Clinical Evaluation of Biological Products,Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)

机构地区：[1]国家药品监督管理局药品审评中心生物制品临床部,北京100076

出　　处：《中华微生物学和免疫学杂志》2024年第11期978-984,共7页Chinese Journal of Microbiology and Immunology

基　　金：药品监管科学全国重点实验室(2023SKLDRS0146)。

摘　　要：流行性感冒(简称流感)是全球最常见的呼吸道传染病之一,接种流感疫苗是最有效的防控手段。由于流感病毒的抗原漂移,世界卫生组织(WHO)每个流行季前均基于全球流感病毒监测情况,推荐下一流行季的流感疫苗株,指导业界开展疫苗生产。针对WHO的疫苗推荐意见,包括我国在内的各国监管机构都制定了相应的监管要求,从而保证疫苗的安全性、有效性和质量可控性。本文系统总结了全球季节性流感定期疫苗推荐机制、部分国家监管机构监管要求和通常路径,同时涉及流感大流行中疫苗的选定和监管机构应对经验,对面临挑战和未来发展方向进行了探讨,旨在为今后流感疫苗和其他类似疫苗的研发和监管提供参考。Influenza is one of the most common respiratory infectious diseases worldwide,and vaccination against influenza is the most effective means of prevention and control.Due to the antigenic drift of influenza viruses,the World Health Organization(WHO)recommends the vaccine strains for the next influenza season based on global surveillance data.This guidance informs the industry′s vaccine production efforts.Based on the vaccine recommendation issued by the WHO,regulatory authorities in various countries,including China,have formulated corresponding regulatory requirements to ensure the safety,effectiveness,and quality of vaccines.This review summarizes the regular vaccine recommendation mechanisms for seasonal influenza,the regulatory requirements and typical pathways of some national regulatory authorities,the selection of vaccines during influenza pandemics,and the regulatory authorities′response experiences.Besides,the current challenges and the future of development are discussed in this article,aiming to provide reference for the research,development,and regulation of influenza vaccines and other similar vaccines in the future.

关 键 词：流感病毒 流感疫苗 疫苗株 监管 

分 类 号：R392-33[医药卫生—免疫学]