预防用mRNA疫苗非临床安全性研究一般原则及关注点

Non-clinical safety evaluation of prophylactic mRNA vaccine:general principles and concerns

信使RNA(mRNA)疫苗是指将编码抗原的mRNA通过载体递送进入机体细胞后表达相应抗原,引发特异性免疫反应的一类新型核酸疫苗。在防控新型冠状病毒(SARS-CoV-2)导致的新型冠状病毒肺炎(COVID-19)疫情中,mRNA疫苗展现了良好的人群保护力和安全性。2021年世界卫生组织颁布了专门针对预防用mRNA疫苗的指导原则,为mRNA疫苗非临床研究提供了重要的指导意义。同时,在mRNA疫苗临床试验及应用过程中,也发现了部分非常见不良反应,如脑血管疾病、栓塞性卒中、短暂脑缺血、深静脉血栓、心肌炎(心包炎)和过敏反应,应在非临床研究中引起关注。

Messenger RNA(mRNA)vaccine,with antigen-encoded mRNA packaged in delivery vehicles,performs its functions via antigen translation and specific immune response.mRNA vaccines have proven their protective effects and safety in the ongoing COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2(SARS-CoV-2).The World Health Organization issued guidelines specifically for prophylactic mRNA vaccines in 2021,which provide important guidance for non-clinical research on mRNA vaccines.Furthermore,some unusual adverse reactions,such as cere⁃brovascular disease,embolic stroke,transient cerebral ischemia,deep vein thrombosis,myocarditis(pericarditis)and allergic reactions,have been also found in clinical trials and applications of mRNA vaccines,which deserves attention in non-clinical studies.