Safety and Effectiveness of COVID-19 Vaccines During Pregnancy: A Living Systematic Review and Meta-analysis.

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Drug Safety Pub Date : 2024-10-01 Epub Date: 2024-07-15 DOI:10.1007/s40264-024-01458-w
Agustín Ciapponi, Mabel Berrueta, Fernando J Argento, Jamile Ballivian, Ariel Bardach, Martin E Brizuela, Noelia Castellana, Daniel Comandé, Sami Gottlieb, Beate Kampmann, Agustina Mazzoni, Edward P K Parker, Juan M Sambade, Katharina Stegelmann, Xu Xiong, Andy Stergachis, Pierre Buekens
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Abstract

Background: Pregnant persons are susceptible to significant complications following COVID-19, even death. However, worldwide COVID-19 vaccination coverage during pregnancy remains suboptimal.

Objective: This study assessed the safety and effectiveness of COVID-19 vaccines administered to pregnant persons and shared this evidence via an interactive online website.

Methods: We followed Cochrane methods to conduct this living systematic review. We included studies assessing the effects of COVID-19 vaccines in pregnant persons. We conducted searches every other week for studies until October 2023, without restrictions on language or publication status, in ten databases, guidelines, preprint servers, and COVID-19 websites. The reference lists of eligible studies were hand searched to identify additional relevant studies. Pairs of review authors independently selected eligible studies using the web-based software COVIDENCE. Data extraction and risk of bias assessment were performed independently by pairs of authors. Disagreements were resolved by consensus. We performed random-effects meta-analyses of adjusted relative effects for relevant confounders of comparative studies and proportional meta-analyses to summarize frequencies from one-sample studies using R statistical software. We present the GRADE certainty of evidence from comparative studies. Findings are available on an interactive living systematic review webpage, including an updated evidence map and real-time meta-analyses customizable by subgroups and filters.

Results: We included 177 studies involving 638,791 participants from 41 countries. Among the 11 types of COVID-19 vaccines identified, the most frequently used platforms were mRNA (154 studies), viral vector (51), and inactivated virus vaccines (17). Low to very low-certainty evidence suggests that vaccination may result in minimal to no important differences compared to no vaccination in all assessed maternal and infant safety outcomes from 26 fewer to 17 more events per 1000 pregnant persons, and 13 fewer to 9 more events per 1000 neonates, respectively. We found statistically significant reductions in emergency cesarean deliveries (9%) with mRNA vaccines, and in stillbirth (75-83%) with mRNA/viral vector vaccines. Low to very low-certainty evidence suggests that vaccination during pregnancy with mRNA vaccines may reduce severe cases or hospitalizations in pregnant persons with COVID-19 (72%; 95% confidence interval [CI] 42-86), symptomatic COVID-19 (78%; 95% CI 21-94), and virologically confirmed SARS-CoV-2 infection (82%; 95% CI 39-95). Reductions were lower with other vaccine types and during Omicron variant dominance than Alpha and Delta dominance. Infants also presented with fewer severe cases or hospitalizations due to COVID-19 and laboratory-confirmed SARS-CoV-2 infection (64%; 95% CI 37-80 and 66%; 95% CI 37-81, respectively).

Conclusions: We found a large body of evidence supporting the safety and effectiveness of COVID-19 vaccines during pregnancy. While the certainty of evidence is not high, it stands as the most reliable option available, given the current absence of pregnant individuals in clinical trials. Results are shared in near real time in an accessible and interactive format for scientists, decision makers, clinicians, and the general public. This living systematic review highlights the relevance of continuous vaccine safety and effectiveness monitoring, particularly in at-risk populations for COVID-19 impact such as pregnant persons, during the introduction of new vaccines.

Clinical trial registration: PROSPERO: CRD42021281290.

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孕期接种 COVID-19 疫苗的安全性和有效性:活体系统综述与元分析》。
背景:孕妇接种 COVID-19 后容易出现严重并发症,甚至死亡。然而,全球范围内孕期接种 COVID-19 疫苗的覆盖率仍未达到最佳水平:本研究评估了孕妇接种 COVID-19 疫苗的安全性和有效性,并通过互动在线网站分享了这些证据:方法:我们遵循 Cochrane 方法开展了这项活系统综述。我们纳入了评估 COVID-19 疫苗对孕妇影响的研究。我们每隔一周在十个数据库、指南、预印本服务器和 COVID-19 网站上检索一次研究,检索期至 2023 年 10 月,不限制语言和出版状态。对符合条件的研究的参考文献目录进行人工检索,以确定其他相关研究。一对综述作者使用基于网络的软件 COVIDENCE 独立选择符合条件的研究。数据提取和偏倚风险评估由两位作者独立完成。如有分歧,则以协商一致的方式解决。我们使用 R 统计软件对比较研究中相关混杂因素的调整相对效应进行了随机效应荟萃分析,并对单样本研究的频率进行了比例荟萃分析。我们介绍了比较研究证据的 GRADE 确定性。研究结果可在互动式活体系统综述网页上查阅,其中包括最新的证据地图和可按亚组和过滤器自定义的实时荟萃分析:我们纳入了 177 项研究,涉及 41 个国家的 638,791 名参与者。在已确定的 11 种 COVID-19 疫苗中,最常用的平台是 mRNA(154 项研究)、病毒载体(51 项)和灭活病毒疫苗(17 项)。低确定性到极低确定性的证据表明,与不接种疫苗相比,接种疫苗在所有评估的孕产妇和婴儿安全结果中可能会导致极小到无重要差异,分别是每 1000 名孕妇少发生 26 例到多发生 17 例事件,以及每 1000 名新生儿少发生 13 例到多发生 9 例事件。我们发现,接种 mRNA 疫苗后,紧急剖宫产率(9%)和死胎率(75%-83%)均有明显降低。低确定性到极低确定性的证据表明,怀孕期间接种 mRNA 疫苗可减少 COVID-19 (72%;95% 置信区间 [CI]42-86)、无症状 COVID-19 (78%;95% CI 21-94)和病毒学证实的 SARS-CoV-2 感染(82%;95% CI 39-95)孕妇的严重病例或住院治疗。接种其他类型疫苗以及在 Omicron 变种占优势期间,降低率低于 Alpha 和 Delta 占优势期间。婴儿因 COVID-19 和实验室确诊的 SARS-CoV-2 感染而导致的严重病例或住院治疗也较少(分别为 64%; 95% CI 37-80 和 66%; 95% CI 37-81):我们发现大量证据支持孕期接种 COVID-19 疫苗的安全性和有效性。结论:我们发现大量证据支持 COVID-19 疫苗在妊娠期的安全性和有效性。虽然证据的确定性不高,但鉴于目前临床试验中没有妊娠期个体,COVID-19 是最可靠的选择。研究结果将以近乎实时的可访问和互动形式与科学家、决策者、临床医生和公众分享。这篇有生命力的系统性综述强调了在引入新疫苗期间持续监测疫苗安全性和有效性的意义,尤其是在孕妇等受 COVID-19 影响的高危人群中:临床试验注册:prospero: crd42021281290。
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来源期刊
Drug Safety
Drug Safety 医学-毒理学
CiteScore
7.60
自引率
7.10%
发文量
112
审稿时长
6-12 weeks
期刊介绍: Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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