COVID-19 vaccine safety studies among special populations: A systematic review and meta-analysis of 120 observational studies and randomized clinical trials

IF 4.5 3区医学 Q2 IMMUNOLOGY

Vaccine Pub Date : 2025-06-04 DOI:10.1016/j.vaccine.2025.127342

Sima Mohammadi , Malede Mequanent Sisay , Putri Widi Saraswati , Alhadi Khogali Osman , Nicolaas P.A. Zuithoff , Daniel Weibel , Miriam Sturkenboom , Fariba Ahmadizar

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引用次数: 0

Abstract

Background

The COVID-19 vaccines were rapidly developed and tested, but concerns about vaccine-related adverse events remain, especially in special groups like pregnant women, children, and those with certain health conditions. This review aims to summarize rates of such adverse events in individuals often not included in randomized clinical trials (RCT).

Method

From December 2019 to February 2022, we searched Embase and Medline for observational studies and RCTs on adverse events post-COVID-19 vaccination in special populations. We examined severe and non-severe events in individuals with specific medical conditions, infants, children, pregnant individuals, and socioeconomically disadvantaged individuals. Cumulative risks for all events were calculated. The Incidence rate (IR) and 95% confidence intervals were reported for those studies that met the follow-up period criteria based on the referenced literature. For events with data on exposed and unexposed groups, we calculated the odds ratio (OR). Pooled incidence rates were calculated per 1000,000 person-days using a random-effects model. Sub-group analyses were conducted based on vaccine types and doses, with heterogeneity assessed using I².

Results

Of the 4,254 papers, 235 met eligibility criteria, including 120 studies with 171,073 participants (113 observational, eight RCTs). We examined 17 severe and seven non-severe adverse event categories. Lymphadenopathy (IR: 1950[1200,3190]), autoimmune disease and multiple sclerosis flare-up (1130 [470,2680]), and cardiac symptoms (0.26[0.00,10.58]) were the most prevalent severe adverse events. Autoimmune disease flare-ups and cardiac symptoms were more common following the second dose compared to the first dose. The overall incidence of serious adverse events was low in children and adolescents, pregnant, autoimmune, and cancer patients.

Discussion

This review highlights COVID-19 vaccine safety in special populations, enhancing vaccination strategies. Further real-world research is needed to validate and extend our findings, especially in addressing safety gaps among special groups.

查看原文本刊更多论文

特殊人群中COVID-19疫苗安全性研究：120项观察性研究和随机临床试验的系统回顾和荟萃分析

COVID-19疫苗迅速开发和测试，但对疫苗相关不良事件的担忧仍然存在，特别是在孕妇、儿童和具有某些健康状况的人等特殊群体中。本综述旨在总结在随机临床试验（RCT）中未包括的个体中此类不良事件的发生率。方法2019年12月至2022年2月，检索Embase和Medline网站，检索特殊人群covid -19疫苗接种后不良事件的观察性研究和随机对照试验。我们检查了有特殊医疗条件的个体、婴儿、儿童、孕妇和社会经济上处于不利地位的个体的严重和非严重事件。计算所有事件的累积风险。根据参考文献，报告那些符合随访期标准的研究的发病率（IR）和95%置信区间。对于有暴露组和未暴露组数据的事件，我们计算了比值比（OR）。使用随机效应模型计算每100万人日的合并发病率。根据疫苗类型和剂量进行亚组分析，使用I2评估异质性。结果在4254篇论文中，235篇符合入选标准，包括120项研究，171,073名受试者（113项观察性研究，8项随机对照试验）。我们检查了17个严重和7个非严重不良事件类别。淋巴结病变（IR: 1950[1200,3190]）、自身免疫性疾病和多发性硬化症发作（1130[470,2680]）和心脏症状（0.26[0.00,10.58]）是最常见的严重不良事件。与第一次剂量相比，第二次剂量后自身免疫性疾病发作和心脏症状更常见。在儿童和青少年、孕妇、自身免疫和癌症患者中，严重不良事件的总体发生率较低。本综述强调了COVID-19疫苗在特殊人群中的安全性，加强了疫苗接种策略。需要进一步的现实世界研究来验证和扩展我们的发现，特别是在解决特殊群体的安全差距方面。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Vaccine 医学-免疫学

CiteScore

8.70

自引率

5.50%

发文量

992

审稿时长

131 days

期刊介绍： Vaccine is unique in publishing the highest quality science across all disciplines relevant to the field of vaccinology - all original article submissions across basic and clinical research, vaccine manufacturing, history, public policy, behavioral science and ethics, social sciences, safety, and many other related areas are welcomed. The submission categories as given in the Guide for Authors indicate where we receive the most papers. Papers outside these major areas are also welcome and authors are encouraged to contact us with specific questions.