The rapid process of research and development and lack of follow-up time post-vaccination aroused great public concern about the safety profile of COVID-19 vaccine candidates. To provide comprehensive overview of the safety profile of COVID-19 vaccines by using meta-analysis technique. English-language articles and results posted on PubMed, Embase, Web of Science, PMC, official regulatory websites, and post-authorization safety surveillance data were searched through June 12, 2021. Publications disclosing safety data of COVID-19 candidate vaccines in humans were included. A meta-analysis of proportions was performed to estimate the pooled incidence and the pooled rate ratio (RR) of safety outcomes of COVID-19 vaccines using different platforms. A total of 87 publications with safety data from clinical trials and post-authorization studies of 19 COVID-19 vaccines on 6 different platforms were included. The pooled rates of local and systemic reactions were significantly lower among inactivated vaccines (23.7%, 21.0%), protein subunit vaccines (33.0%, 22.3%), and DNA vaccines (39.5%, 29.3%), compared to RNA vaccines (89.4%, 83.3%), non-replicating vector vaccines (55.9%, 66.3%), and virus-like particle vaccines (100.0%, 78.9%). Solicited injection-site pain was the most common local reactions, and fatigue and headache were the most common systemic reactions. The frequency of vaccine-related serious adverse events was low (< 0.1%) and balanced between treatment groups. Vaccine platforms and age groups of vaccine recipients accounted for much of the heterogeneity in safety profiles between COVID-19 vaccines. Reporting rates of adverse events from post-authorization observational studies were similar to results from clinical trials. Crude reporting rates of adverse events from post-authorization safety monitoring (passive surveillance) were lower than in clinical trials and varied between countries. Available evidence indicates that eligible COVID-19 vaccines have an acceptable short-term safety profile. Additional studies and long-term population-level surveillance are strongly encouraged to further define the safety profile of COVID-19 vaccines.

中文翻译：

---

COVID-19 疫苗的安全性评估：快速审查


快速的研发过程和疫苗接种后缺乏随访时间引起了公众对 COVID-19 候选疫苗安全性的极大关注。使用荟萃分析技术全面概述 COVID-19 疫苗的安全性。截至 2021 年 6 月 12 日，检索了 PubMed、Embase、Web of Science、PMC、官方监管网站上发布的英文文章和结果以及授权后安全监测数据。公开了 COVID-19 候选疫苗在人类中的安全数据的出版物包括。对比例进行荟萃分析，以估计使用不同平台的 COVID-19 疫苗安全性结果的汇总发生率和汇总率比 (RR)。共纳入 87 篇出版物，其中包含 6 个不同平台上 19 种 COVID-19 疫苗的临床试验和授权后研究的安全数据。与 RNA 疫苗（89.4%）相比，灭活疫苗（23.7%、21.0%）、蛋白质亚单位疫苗（33.0%、22.3%）和 DNA 疫苗（39.5%、29.3%）的局部和全身反应汇总率显着较低。 %、83.3%）、非复制载体疫苗（55.9%、66.3%）和病毒样颗粒疫苗（100.0%、78.9%）。注射部位疼痛是最常见的局部反应，疲劳和头痛是最常见的全身反应。与疫苗相关的严重不良事件的发生率较低（< 0.1%），并且在治疗组之间保持平衡。疫苗平台和疫苗接种者的年龄组是造成 COVID-19 疫苗安全性差异的主要原因。授权后观察性研究的不良事件报告率与临床试验的结果相似。 授权后安全监测（被动监测）不良事件的粗略报告率低于临床试验，并且各国之间存在差异。现有证据表明，符合条件的 COVID-19 疫苗具有可接受的短期安全性。强烈鼓励进行更多研究和长期人群监测，以进一步确定 COVID-19 疫苗的安全性。