Department of Pediatrics, Renmin Hospital of Wuhan University, Wuhan 430060, China.
Zhongguo Dang Dai Er Ke Za Zhi. 2021 Mar;23(3):221-228. doi: 10.7499/j.issn.1008-8830.2101133.
To evaluate systematically the efficacy and safety of COVID-19 vaccines.
PubMed, Embase, Cochrane Library, Clinicaltrial.gov, CNKI, Wanfang Data, China Biomedical Literature Service System, and China Clinical Trial Registry were searched for randomized controlled trials of COVID-19 vaccines published up to December 31, 2020. The Cochrane bias risk assessment tool was used to assess the quality of studies. A qualitative analysis was performed on the results of clinical trials.
Thirteen randomized, blinded, controlled trials, which involved the safety and efficacy of 11 COVID-19 vaccines, were included. In 10 studies, the 28-day seroconversion rate of subjects exceeded 80%. In two 10 000-scale clinical trials, the vaccines were effective in 95% and 70.4% of the subjects, respectively. The seroconversion rate was lower than 60% in only one study. In six studies, the proportion of subjects who had an adverse reaction within 28 days after vaccination was lower than 30%. This proportion was 30%-50% in two studies and > 50% in the other two studies. Most of the adverse reactions were mild to moderate and resolved within 24 hours after vaccination. The most common local adverse reaction was pain or tenderness at the injection site, and the most common systemic adverse reaction was fatigue, fever, or bodily pain. The immune response and incidence of adverse reactions to the vaccines were positively correlated with the dose given to the subjects. The immune response to the vaccines was worse in the elderly than in the younger population. In 6 studies that compared single-dose and double-dose vaccination, 4 studies showed that double-dose vaccination produced a stronger immune response than single-dose vaccination.
Most of the COVID-19 vaccines appear to be effective and safe. Double-dose vaccination is recommended. However, more research is needed to investigate the long-term efficacy and safety of the vaccines and the influence of dose, age, and production process on the protective efficacy.
系统评价 COVID-19 疫苗的有效性和安全性。
检索 2020 年 12 月 31 日前发表的 COVID-19 疫苗随机对照试验，数据库包括 PubMed、Embase、Cochrane Library、Clinicaltrial.gov、CNKI、万方数据、中国生物医学文献服务系统、中国临床试验注册中心。使用 Cochrane 偏倚风险评估工具评估研究质量。对临床试验结果进行定性分析。
共纳入 13 项随机、双盲、对照试验，涉及 11 种 COVID-19 疫苗的安全性和有效性。在 10 项研究中，接种者 28 天血清转化率超过 80%。在两项 10000 例规模的临床试验中，疫苗在 95%和 70.4%的接种者中有效。仅有 1 项研究的血清转化率低于 60%。在 6 项研究中，接种后 28 天内不良反应发生率低于 30%。2 项研究的这一比例为 30%~50%，另外 2 项研究则高于 50%。大多数不良反应为轻度至中度，接种后 24 小时内缓解。最常见的局部不良反应是注射部位疼痛或压痛，最常见的全身不良反应是疲劳、发热或身体疼痛。疫苗的免疫反应和不良反应发生率与接种者接受的剂量呈正相关。疫苗对老年人的免疫反应不如年轻人。在比较单剂和双剂接种的 6 项研究中，4 项研究表明双剂接种产生的免疫反应强于单剂接种。
大多数 COVID-19 疫苗似乎有效且安全。建议接种双剂疫苗。但是，需要更多研究来调查疫苗的长期疗效和安全性，以及剂量、年龄和生产工艺对保护效果的影响。
