Xu Li, Li Min, He Wu
Center for Drug Evaluation National Medical Products Administration Beijing China.
MedComm (2020). 2024 Jul 5;5(7):e646. doi: 10.1002/mco2.646. eCollection 2024 Jul.
Nowadays, although severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) epidemic has been handled with long-term management globally, the virus strains keep continuous evolution in an uncertain direction. The newly emerged JN.1 dominated the globally circulating variants in a short time and resulted in increasing hospitalizations. Up to 2024, variant vaccines with the composition of XBB sub-lineage were available due to the coordinated efforts of developers and regulatory agencies. The development of updated vaccines is still needed and the regular availability of coronavirus disease 2019 (COVID-19) vaccines should be timely guaranteed. The current landscape of COVID-19 vaccines and the strategies for accelerating vaccine development and approval are reviewed. Proposals to enhance variants monitoring and the establishment of the strain recommendation mechanism are made. This review provides suggestions about platform technology designation and application, real-world data leveraging and modification to regulatory pathways both for the post-pandemic era of SARS-CoV-2 and for the future unknown pathogen pandemic.
如今,尽管全球已通过长期管理应对严重急性呼吸综合征冠状病毒2(SARS-CoV-2)疫情,但病毒株仍在朝着不确定的方向持续进化。新出现的JN.1在短时间内成为全球传播的主要变异株,并导致住院人数增加。截至2024年,由于研发人员和监管机构的共同努力,已出现了含XBB亚谱系成分的变异株疫苗。仍需要研发更新的疫苗,应及时确保2019冠状病毒病(COVID-19)疫苗的常规供应。本文综述了COVID-19疫苗的现状以及加速疫苗研发和审批的策略。提出了加强变异株监测和建立毒株推荐机制的建议。本综述针对SARS-CoV-2大流行后的时代以及未来未知病原体大流行,就平台技术的设计与应用、利用真实世界数据以及调整监管途径提供了建议。