Efficacy, Immunogenicity and Safety of COVID-19 Vaccines: A Systematic Review and Meta-Analysis.

Efficacy, Immunogenicity and Safety of COVID-19 Vaccines: A Systematic Review and Meta-Analysis.
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DOI:
10.3389/fimmu.2021.714170
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发表时间:
2021
影响因子:
7.3
通讯作者:
Dey SK
Dey SK
中科院分区:
医学2区
文献类型:
--
作者:
Sharif N;Alzahrani KJ;Ahmed SN;Dey SK

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在关于冠状病毒病2019年(新冠肺炎)疫苗有效性和安全性的荟萃分析方面存在着显著的研究空白。这项研究分析了新冠肺炎疫苗的效力。已发表的分析安全性和免疫原性的第一阶段、第二阶段和第三阶段试验,以及评估新冠肺炎疫苗有效性的第三阶段随机临床试验都包括在内。我们在MEDLINE、SCOPUS和《柳叶刀》杂志上搜索已发表的评估接种后新冠肺炎风险相对降低的文章。有关新冠肺炎疫苗的安全性、有效性和免疫原性的文献在2019年12月15日至2021年5月15日期间发表。这项荟萃分析纳入了使用逆转录聚合酶链式反应确认新冠肺炎病例的研究。这项研究检测到8,926篇发表在新冠肺炎疫苗上的合格研究文章。在这些研究中,有25项符合纳入标准。在入选文章中,19篇随机临床试验、2篇非随机临床试验和3篇观察性研究进行了分析。7项研究(28%)纳入荟萃分析。在18岁的≥受试者中,腺病毒载体疫苗和信使核糖核酸疫苗的有效率分别为73%(95%CI=69~77)和85%(95%CI=82~88)。目前还没有关于16岁以下参与者进行临床试验的报道。据报道,在第一次或第二次接种疫苗后0-30天内,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型(SARS-CoV-2)受体结合域(RBDS)的中和抗体。注射部位疼痛是接受信使核糖核酸疫苗的人最常见的局部症状(29%-85%的参与者)。在接受腺病毒载体疫苗的人中,发热(0.2%-95%)是最普遍的,在接受信使核糖核酸疫苗的人中,疲劳(8.4%-55%)是最常见的副作用。研究表明,信使核糖核酸疫苗和腺病毒载体疫苗可以为18岁以上的人提供中到高度的保护,防止新冠肺炎感染。这些疫苗在16岁以下人群中对新冠肺炎多种变种具有长期保护作用的证据有限。本研究将对新冠肺炎疫苗的有效性、安全性和免疫原性进行综合评价。
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.
DOI: 10.1056/nejmoa2026920
发表时间: 2020-12-10
影响因子: 158.5
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发表时间: 2020-10-13
影响因子: 39.3
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