PaedVacCOVID - safety of the BNT162b2 vaccine against the SARS-CoV-2 in children with and without comorbidities aged 5 to 11 years.

IF 5.4 2区医学 Q1 INFECTIOUS DISEASES

Infection Pub Date : 2024-11-11 DOI:10.1007/s15010-024-02427-2

Sarah Holzwarth, Kimiya Saadat, Maximilian Jorczyk, Svenja Dreßen, Sarah Kotsias-Konopelska, Anne Schlegtendal, Christoph Maier, Jochen Schmitt, Kevin Paul, Julia Pagel, Ania C Muntau, Reinhard Berner, Folke Brinkmann, Nicole Toepfner

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引用次数: 0

Abstract

Background: Little is known about specific safety aspects in children with significant comorbidities receiving the mRNA vaccine BNT162b2, as approval studies did not address this population. This study's purpose is to evaluate safety and adverse events in these children compared to healthy children.

Methods: In this prospective, multicentre, industry-independent cohort study, caregivers whose children received BNT162b2 were asked to participate in an online questionnaire. Potential side effects were evaluated in ten organ related categories. Frequency of symptoms was compared in both cohorts by bivariate analysis.

Results: From a total of 1,294 responses to the questionnaire, 793 data sets were included into the analysis (179 children with comorbidities and 614 healthy children). Responses were given at a median of 17 days after vaccination. Overall, safety of BNT162b2 was high in both cohorts. Psychological (OR: 3.56, [95% CI: 1.461 to 8.629]), pulmonary (OR: 7.14, [95% CI: 2.039 to 21.48]), gastrointestinal (OR: 2.35, [95% CI: 1.231 to 4.665]), neurological (OR: 1.74, [95% CI: 1.078 to 2.796]) and dermatological (OR: 2.28, [95% CI: 1.220 to 4.172]) side effects were increased in children with comorbidities over healthy controls.

Conclusion: The higher rate of reported post-vaccination symptoms could either be due to a higher susceptibility for symptomatic effects following immune stimulation, or due to a trained awareness to health-related symptoms. The data emphasizes the importance to evaluate safety of the new mRNA COVID-19 vaccines not only in healthy children but also in children with comorbidities. To perform such evaluation should be made mandatory for pharmaceutical enterprises.

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PaedVacCOVID - BNT162b2疫苗对5至11岁患有和未患有SARS-CoV-2的儿童的安全性。

背景：关于患有严重合并症的儿童接种 mRNA 疫苗 BNT162b2 的具体安全性问题知之甚少，因为批准的研究并未涉及这一人群。本研究的目的是评估这些儿童与健康儿童相比的安全性和不良事件：在这项前瞻性、多中心、独立于行业的队列研究中，儿童接种了 BNT162b2 的照顾者被要求参与在线问卷调查。潜在副作用按十个器官相关类别进行评估。通过双变量分析比较了两个队列中的症状频率：共收到 1,294 份问卷，其中 793 组数据被纳入分析（179 名患有合并症的儿童和 614 名健康儿童）。回答时间中位数为接种疫苗后 17 天。总体而言，BNT162b2 在两个组群中的安全性都很高。心理（OR：3.56，[95% CI：1.461 至 8.629]）、肺（OR：7.14，[95% CI：2.039 至 21.48]）、胃肠（OR：2.35，[95% CI：1.231 至 4.665]）、神经（OR：1.74，[95% CI：1.078 至 2.796]）和皮肤病（OR：2.28，[95% CI：1.220 至 4.172]）副作用在有合并症的儿童中比健康对照组增加：接种后症状报告率较高的原因可能是免疫刺激后更容易出现症状效应，也可能是对健康相关症状的认识有所提高。这些数据强调了评估新型 mRNA COVID-19 疫苗安全性的重要性，不仅要评估健康儿童的安全性，还要评估有合并症儿童的安全性。制药企业应强制执行此类评估。

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

Infection 医学-传染病学

CiteScore

12.50

自引率

1.30%

发文量

224

审稿时长

6-12 weeks

期刊介绍： Infection is a journal dedicated to serving as a global forum for the presentation and discussion of clinically relevant information on infectious diseases. Its primary goal is to engage readers and contributors from various regions around the world in the exchange of knowledge about the etiology, pathogenesis, diagnosis, and treatment of infectious diseases, both in outpatient and inpatient settings. The journal covers a wide range of topics, including: Etiology: The study of the causes of infectious diseases. Pathogenesis: The process by which an infectious agent causes disease. Diagnosis: The methods and techniques used to identify infectious diseases. Treatment: The medical interventions and strategies employed to treat infectious diseases. Public Health: Issues of local, regional, or international significance related to infectious diseases, including prevention, control, and management strategies. Hospital Epidemiology: The study of the spread of infectious diseases within healthcare settings and the measures to prevent nosocomial infections. In addition to these, Infection also includes a specialized "Images" section, which focuses on high-quality visual content, such as images, photographs, and microscopic slides, accompanied by brief abstracts. This section is designed to highlight the clinical and diagnostic value of visual aids in the field of infectious diseases, as many conditions present with characteristic clinical signs that can be diagnosed through inspection, and imaging and microscopy are crucial for accurate diagnosis. The journal's comprehensive approach ensures that it remains a valuable resource for healthcare professionals and researchers in the field of infectious diseases.