Yunnan Center for Disease Control and Prevention, China.
Medical Affairs Department, Sinovac Life Sciences Co., Ltd, China.
Vaccine. 2023 Feb 10;41(7):1354-1361. doi: 10.1016/j.vaccine.2023.01.020. Epub 2023 Jan 13.
To evaluate the safety of primary immunization using CoronaVac® among population aged 3 years and above in a large-scale use.
A multi-center open-label study was carried out in 11 provinces of China. Individuals aged 3 years and older who had no history of COVID-19 vaccination or had received only one dose of CoronaVac® were enrolled in this study. Adults and elderly with or without underlying medical conditions(UMCs) were also recruited. Eligible participants received one or two doses of CoronaVac® with an interval of 28 days. Demographic information, vaccination and the occurrence of adverse events were recorded by participants or guardians using data collection system designed for this study. All adverse events occurred within 6 months after the second dose of vaccination were collected. The incidence of adverse events that cannot be ruled out as being caused by the vaccine were calculated to assess the safety of CoronaVac®. This study is registered with ClinicalTrials. Gov (NCT04911790 and NCT04992208).
A total of 162,691 participants have been included in this study and 89.50 % had finished primary immunization. Among adults and elderly, people with UMCs accounted for 25.85 %, with the top five disease being hypertension, diabetes, chronic gastritis, coronary heart disease(CHD) and kidney stone. The overall incidence of adverse reactions (ARs) within 6 months after the second vaccination was 2.70 %, with incidence for children and adolescents, adults, and elderly being 2.03 %, 3.46 %, and 1.90 %, respectively. Most ARs were mild (grade 1). Pain at the injection sites, fatigue, induration/swelling, and headache were the most common symptoms, occurring in 1.64 %, 0.46 %, 0.31 % and 0.24 %, respectively. No serious adverse events related to vaccines were reported. No adverse events of special interest (AESIs) were identified. For children and adolescents, children aged 3-5 years had the highest incidence of ARs of 3.29 %. The incidence of ARs among those aged 18 years and older with and without UMCs were 2.81 % and 2.99 %, respectively, with no statistical significance between two groups(P = 0.089). And people with coronary heart disease had higher AR incidence compared to those with other UMCs, but the most common symptoms was pain at the injection site.
CoronaVac® is safe in a large-scale use and shows well-tolerance for children and adolescents and people with underlying medical conditions. Further studies need to be conducted to explore the relation of ARs incidence to age or different kinds of UMCs.
评估 CoronaVac®在大规模使用中对 3 岁及以上人群进行基础免疫的安全性。
在中国 11 个省进行了一项多中心、开放性标签研究。既往无新冠病毒疫苗接种史或仅接种过 1 剂 CoronaVac®的 3 岁及以上人群纳入本研究。同时招募有或无基础疾病（UMC）的成人和老年人。符合条件的参与者间隔 28 天接受 1 或 2 剂 CoronaVac®。参与者或监护人使用为本研究设计的数据采集系统记录人口统计学信息、接种情况和不良反应（AE）发生情况。收集所有第二次接种后 6 个月内不能排除疫苗引起的不良反应的发生情况。计算不能排除疫苗引起的不良反应的发生率，以评估 CoronaVac®的安全性。本研究在 ClinicalTrials.gov 注册（NCT04911790 和 NCT04992208）。
本研究共纳入 162691 名参与者，89.50%完成了基础免疫。在成人和老年人中，有 UMC 的占 25.85%，前 5 位疾病为高血压、糖尿病、慢性胃炎、冠心病（CHD）和肾结石。第二次接种后 6 个月内总体不良反应（AR）发生率为 2.70%，儿童和青少年、成年人和老年人的发生率分别为 2.03%、3.46%和 1.90%。大多数不良反应为轻度（1 级）。注射部位疼痛、疲劳、硬结/肿胀和头痛最常见，发生率分别为 1.64%、0.46%、0.31%和 0.24%。未报告与疫苗相关的严重不良事件。未发现特殊关注的不良事件（AESI）。对于儿童和青少年，3-5 岁儿童的 AR 发生率最高，为 3.29%。有和无 UMC 的 18 岁及以上人群的 AR 发生率分别为 2.81%和 2.99%，两组间无统计学差异（P=0.089）。冠心病患者的 AR 发生率高于其他 UMC 患者，但最常见的症状是注射部位疼痛。
CoronaVac®在大规模使用中是安全的，对儿童和青少年以及有基础疾病的人群具有良好的耐受性。需要进一步研究以探讨 AR 发生率与年龄或不同类型 UMC 之间的关系。
