Li Xiaoming, Yang Xia, Ning Zong
Department of General Practice, School of Graduate Studies, Guangxi Medical University, Nanning, China.
Department of General Practice, The First Affiliated Hospital of Guangxi Medical University, Guangxi Medical University, Nanning, China.
Front Med (Lausanne). 2022 Nov 7;9:1015184. doi: 10.3389/fmed.2022.1015184. eCollection 2022.
Inactivated vaccine is one of the primary technology types of Coronavirus Disease 2019 (COVID-19) vaccines, which has wide application in many countries, including mainland China. However, systematic evaluation of the efficacy and safety of COVID-19 inactivated vaccines remains limited. And trust in the vaccine is the key to solving vaccine hesitancy.
Various academic databases were searched comprehensively for randomized controlled trials (RCTs) related to COVID-19 inactivated vaccines. The deadline for retrieval was December 2021. Study screening and data extraction were according to inclusive and exclusive criteria. Statistical analyses were performed using RevMan software 5.3 version and STATA software 16.0 version.
Eight studies with 79,334 subjects were included of which 48,123 had received two doses of COVID-19 inactivated vaccines, and 31,211 had received two doses of placebo. The results of the meta-analysis showed that: in terms of effectiveness evaluation, two doses of COVID-19 inactivated vaccines decreased the symptomatic infection [relative risk (RR) = 0.23, 95% confidence interval (CI) (0.18,0.30), < 0.00001], asymptomatic infection [RR = 0.48, 95%CI (0.32, 0.74), = 0.0008], total infection [RR = 0.32, 95%CI (0.24, 0.41), < 0.00001] and hospitalization [RR = 0.06, 95%CI (0.01, 0.27), = 0.0002] for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) significantly. In terms of safety assessment, two doses of COVID-19 inactivated vaccines also caused more adverse events. After two inoculations, total adverse events and systemic adverse events increased significantly [total adverse events RR = 1.14, 95%CI (1.08, 1.21), < 0.00001; systemic adverse events RR = 1.22, 95%CI (1.09, 1.35), = 0.0002]. The most common adverse event was pain at the injection site. Almost all local adverse reactions consisted of these events. The incidence of pain at the injection site was related to adjuvants. Using aluminum hydroxide as an adjuvant increased local pain significantly [RR = 1.97, 95%CI (1.52, 2.55), < 0.00001]. Two doses COVID-19 inactivated vaccines did not increase serious adverse events [RR = 0.71, 95%CI (0.57, 0.90), = 0.004].
Two doses of inactivated COVID-19 vaccines in people over 18 years of age effectively prevented SARS-CoV-2 infection and its associated hospitalizations. Short-term, mild to moderate adverse reactions had occurred, but serious adverse events were rare. No placebo or vaccine-related deaths had been reported.
https://www.crd.york.ac.uk/prospero/, identifier: 42021291250.
灭活疫苗是2019冠状病毒病（COVID-19）疫苗的主要技术类型之一，在包括中国大陆在内的许多国家广泛应用。然而，对COVID-19灭活疫苗的有效性和安全性的系统评价仍然有限。而对疫苗的信任是解决疫苗犹豫问题的关键。
全面检索各种学术数据库，查找与COVID-19灭活疫苗相关的随机对照试验（RCT）。检索截止日期为2021年12月。研究筛选和数据提取依据纳入和排除标准进行。使用RevMan软件5.3版本和STATA软件16.0版本进行统计分析。
纳入8项研究，共79334名受试者，其中48123人接种了两剂COVID-19灭活疫苗，31211人接种了两剂安慰剂。荟萃分析结果显示：在有效性评估方面，两剂COVID-19灭活疫苗显著降低了严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的有症状感染[相对危险度（RR）=0.23，95%置信区间（CI）（0.18，0.30），P<0.00001]、无症状感染[RR = 0.48，95%CI（0.32，0.74），P = 0.0008]、总感染[RR = 0.32，95%CI（0.24，0.41），P<0.00001]以及住院率[RR = 0.06，95%CI（0.01，0.27），P = 0.0002]。在安全性评估方面，两剂COVID-19灭活疫苗也导致了更多不良事件。两次接种后，总不良事件和全身不良事件显著增加[总不良事件RR = 1.14，95%CI（1.08，1.21），P<0.00001；全身不良事件RR = 1.22，95%CI（1.09，1.35），P = 0.0002]。最常见的不良事件是注射部位疼痛。几乎所有局部不良反应均由这些事件组成。注射部位疼痛的发生率与佐剂有关。使用氢氧化铝作为佐剂会显著增加局部疼痛[RR = 1.97，95%CI（1.52，2.55），P<0.00001]。两剂COVID-19灭活疫苗并未增加严重不良事件[RR = 0.71，95%CI（0.57，0.90），P = 0.004]。
18岁以上人群接种两剂COVID-19灭活疫苗可有效预防SARS-CoV-2感染及其相关住院。发生了短期的轻至中度不良反应，但严重不良事件罕见。未报告与安慰剂或疫苗相关的死亡病例。
