Department of Microbiology, Jahangirnagar University, Dhaka, Bangladesh.
Department of Clinical Laboratories Sciences, College of Applied Medical Sciences, Taif University, Taif, Saudi Arabia.
Front Immunol. 2021 Oct 11;12:714170. doi: 10.3389/fimmu.2021.714170. eCollection 2021.
There is a significant research gap in meta-analysis on the efficacy and safety of coronavirus disease 2019 (COVID-19) vaccines. This study analyzed the efficacy of COVID-19 vaccines. Published phase I, phase II, and phase III trials analyzing safety and immunogenicity and phase III randomized clinical trials evaluating the efficacy of COVID-19 vaccines were included. We searched MEDLINE, Scopus, and The Lancet for published articles evaluating the relative reduction in COVID-19 risk after vaccination. Selected literatures were published between December 15, 2019 and May 15, 2021 on the safety, efficacy, and immunogenicity of COVID-19 vaccines. This meta-analysis included studies that confirmed cases of COVID-19 using reverse transcriptase polymerase chain reaction. This study detected 8,926 eligible research articles published on COVID-19 vaccines. Of these, 25 studies fulfilled the inclusion criteria. Among the selected articles, 19 randomized clinical trials, 2 non-randomized clinical trials, and 3 observational studies were analyzed. Seven (28%) studies were included in the meta-analysis. The efficacy of the adenovirus vector vaccine was 73% (95% CI = 69-77) and that of the messenger RNA (mRNA) vaccine was 85% (95% CI = 82-88) in participants aged ≥18 years. There are no reports of clinical trials in participants aged under 16 years. The production of neutralizing antibodies against receptor-binding domains (RBDs) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in >90% of the vaccinated samples was reported within 0-30 days of the first or the second dose of the vaccine. Pain at the injection site was the most common local symptom in people receiving mRNA vaccines (29%-85% of participants). Fever (0.2%-95%) was the most prevalent in people receiving adenovirus vector vaccines, and fatigue (8.4%-55%) was the most common side effect in people receiving the mRNA vaccines. Studies suggest that mRNA vaccines and adenovirus vector vaccines can provide moderate to high protection against COVID-19 infection in people over 18 years. Evidence of the long-term protection of the vaccines in people aged under 16 years against the multiple variants of COVID-19 are limited. This study will provide an integrated evaluation on the efficacy, safety, and immunogenicity of the COVID-19 vaccines.
关于新型冠状病毒病 2019（COVID-19）疫苗的疗效和安全性，荟萃分析存在重大研究空白。本研究分析了 COVID-19 疫苗的疗效。纳入了分析安全性和免疫原性的 I 期、II 期和 III 期试验，以及评估 COVID-19 疫苗疗效的 III 期随机临床试验。我们检索了 MEDLINE、Scopus 和 The Lancet 上发表的评估接种疫苗后 COVID-19 风险相对降低的文章。选择的文献发表于 2019 年 12 月 15 日至 2021 年 5 月 15 日，内容涉及 COVID-19 疫苗的安全性、有效性和免疫原性。本荟萃分析纳入了使用逆转录酶聚合酶链反应（reverse transcriptase polymerase chain reaction）确诊 COVID-19 病例的研究。这项研究检测到了 8926 篇关于 COVID-19 疫苗的合格研究文章。其中，25 项研究符合纳入标准。在入选的文章中，分析了 19 项随机临床试验、2 项非随机临床试验和 3 项观察性研究。有 7 项（28%）研究被纳入荟萃分析。在年龄≥18 岁的参与者中，腺病毒载体疫苗的疗效为 73%（95%CI=69-77），信使 RNA（mRNA）疫苗的疗效为 85%（95%CI=82-88）。目前没有年龄在 16 岁以下的参与者的临床试验报告。在接种疫苗后 0-30 天内，超过 90%的接种样本中产生了针对严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）受体结合域（receptor-binding domains，RBDs）的中和抗体。在接受 mRNA 疫苗的人群中，注射部位疼痛是最常见的局部症状（29%-85%的参与者）。在接受腺病毒载体疫苗的人群中，发热（0.2%-95%）最为常见，在接受 mRNA 疫苗的人群中，疲劳（8.4%-55%）是最常见的副作用。研究表明，mRNA 疫苗和腺病毒载体疫苗能为 18 岁以上人群提供针对 COVID-19 感染的中度至高度保护。关于年龄在 16 岁以下人群的疫苗对 COVID-19 多种变异体的长期保护效果的证据有限。本研究将对 COVID-19 疫苗的疗效、安全性和免疫原性进行综合评估。
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