如何加强中国新型冠状病毒疫苗上市后的安全性警戒

How to Strengthen China's Pharmacovigilance for SARS-CoV-2 Vaccines in Post-marketing Phase

目的探讨新型冠状病毒(简称“新冠病毒”)疫苗获得上市许可并在大规模人群接种时,如何及时发现接种后的安全性事件并全面评估疫苗安全性,以保障受种者安全。方法基于世界卫生组织对新冠病毒疫苗接种前加强警戒准备的建议,借鉴布莱顿协作组的应急疫苗安全平台开发的标准和工具,分析我国疫苗警戒的现状,提出加强新冠病毒疫苗上市后安全警戒的建议。结果鉴于新冠病毒肺炎的病理生理临床表现,加速研发新冠病毒疫苗的技术平台创新性强,疫苗临床试验期间暴露感染的试验人群数量有限,研究人群的多样性和观察时间有限,因此在疫苗大规模使用初期,密切监测疫苗的安全性变得非常关键。结论建议我国制订新冠病毒疫苗上市后的警戒预案,布局资源开展主动监测和加强被动监测疫苗接种后不良事件及特别关注的安全性事件,加强各级权威部门信息的沟通,以增强公众对疫苗接种的信心。

Objective To explore how timely find out the adverse events of specific interest following immunization,comprehensively evaluate the safety profile of vaccines and ensure the safety to recipients when SARS-CoV-2 vaccines are approved for marketing and inoculation to populations in the future.Methods Suggestions on strengthening pharmacovigilance are provided by review of World Health Organization’s recommendations for pharmacovigilance preparedness for the launch of the COVID-19 vaccines,the standards and tools developed by the Brighton Collaboration through Safety Platform for Emergency vACcines and the analysis of China’s pharmacovigilance surveillance systems.Results In view of unusual pathophysiology of COVID-19,innovative technology platform to accelerate development of SARS-CoV-2 vaccine candidates,and limited number of subject exposed,heterogeneity of population studies,and limited period of follow up during pre-licensure trials,it is critical to continue monitoring the safety of vaccine at the time of deployment to further characterize and quantify clinically relevant risks and to identify new reactions.Conclusions It is suggested that China urgently needs to develop a post-marketing monitoring plan for SARS-CoV-2 vaccines,layout resource to carry out active surveillance for vaccine safety and enhance passive surveillance for adverse events following immunization and adverse events of specific interests,strengthen authorities’information communication at all levels to reduce public hesitancy to vaccine.