Xu Wanqian, Ren Weigang, Wu Tongxin, Wang Qin, Luo Mi, Yi Yongxiang, Li Junwei
School of Public Health, The Second Hospital of Nanjing, Nanjing Medical University, Nanjing 211166, China.
The Clinical Infectious Disease Center of Nanjing, Nanjing 210003, China.
Vaccines (Basel). 2023 Jun 19;11(6):1118. doi: 10.3390/vaccines11061118.
With the mass vaccination program for COVID-19 mRNA vaccines, there has been sufficient real-world study (RWS) on the topic to summarize their safety in the total population and in immunocompromised (IC) patients who were excluded from phase 3 clinical trials. We conducted a systematic review and meta-analysis to evaluate the safety of COVID-19 mRNA vaccines, with a total of 5,132,799 subjects from 122 articles. In the case of the total population vaccinated with first, second, and third doses, the pooled incidence of any adverse events (AEs) was 62.20%, 70.39%, and 58.60%; that of any local AEs was 52.03%, 47.99%, and 65.00%; that of any systemic AEs was 29.07%, 47.86%, and 32.71%. Among the immunocompromised patients, the pooled odds ratio of any AEs, any local AEs, and systemic AEs were slightly lower than or similar to those of the healthy controls at 0.60 (95% CI: 0.33-1.11), 0.19 (95% CI: 0.10-0.37), and 0.36 (95% CI: 0.25-0.54), with pooled incidences of 51.95%, 38.82%, and 31.00%, respectively. The spectrum of AEs associated with the vaccines was broad, but most AEs were transient, self-limiting, and mild to moderate. Moreover, younger adults, women, and people with prior SARS-CoV-2 infection were more likely to experience AEs.
随着新冠病毒mRNA疫苗大规模接种计划的开展，关于该主题已有足够的真实世界研究（RWS）来总结其在总人口以及被排除在3期临床试验之外的免疫功能低下（IC）患者中的安全性。我们进行了一项系统评价和荟萃分析，以评估新冠病毒mRNA疫苗的安全性，共纳入了122篇文章中的5,132,799名受试者。在接种第一剂、第二剂和第三剂疫苗的总人口中，任何不良事件（AE）的合并发生率分别为62.20%、70.39%和58.60%；任何局部AE的合并发生率分别为52.03%、47.99%和65.00%；任何全身AE的合并发生率分别为29.07%、47.86%和32.71%。在免疫功能低下的患者中，任何AE、任何局部AE和全身AE的合并比值比略低于或类似于健康对照组，分别为0.60（95%CI：0.33-1.11）、0.19（95%CI：0.10-0.37）和0.36（95%CI：0.25-0.54），合并发生率分别为51.95%、38.82%和31.00%。与疫苗相关的AE谱很广，但大多数AE是短暂的、自限性的，且为轻至中度。此外，较年轻的成年人、女性以及既往感染过严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的人更有可能出现AE。
