Sex differences in symptoms following the administration of BNT162b2 mRNA COVID-19 vaccine in children below 5 years of age in Germany (CoVacU5): a retrospective cohort study.

IF 4.9 2区 医学 Q1 ENDOCRINOLOGY & METABOLISM Biology of Sex Differences Pub Date : 2024-09-26 DOI:10.1186/s13293-024-00651-x
Jeanne Moor, Nicole Toepfner, Wolfgang C G von Meißner, Reinhard Berner, Matthias B Moor, Karolina Kublickiene, Christoph Strumann, Cho-Ming Chao
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Abstract

Background: Sex differences exist not only in the efficacy but also in adverse event rates of many vaccines. Here we compared the safety of BNT162b2 vaccine administered off-label in female and male children younger than 5 years in Germany.

Methods: This is a retrospective cohort study, in which we performed a post-hoc analysis of a dataset collected through an authentication-based survey of individuals having registered children aged 0-<5 years for vaccination against SARS-CoV-2 in six private practices and/or two lay person-initiated vaccination campaigns. We analyzed the safety profiles of the first 3 doses of 3-10 µg BNT162b2. Primary outcome was comparison in frequencies of 4 common post-vaccination symptom categories such as local, general, musculoskeletal symptoms and fever. Data were analyzed according to sex in bivariate analyses and regression models adjusting for age, weight, and dosage. Interaction between sex and BNT162b2 dosage was assessed. An active-comparator analysis was applied to compare post-vaccination symptoms after BNT162b2 versus non-SARS-CoV-2 vaccines.

Results: The dataset for the present analysis consisted of 7801 participants including 3842 females (49%) and 3977 males (51%) with an age of 3 years (median, interquartile: 2 years). Among individuals receiving 3 µg BNT162b2, no sex differences were noted, but after a first dose of 5-10 µg BNT162b2, local injection-site symptoms were more prevalent in girls compared to boys. In logistic regression, female sex was associated with higher odds of local symptoms, odds ratio (OR) of 1.33 (95% confidence interval [CI]: 1.15-1.55, p < 0.05) and general symptoms with OR 1.21 (95% CI: 1.01-1.44, p < 0.05). Following non-BNT162b2 childhood vaccinations, female sex was associated with a lower odds of post-vaccination musculoskeletal symptoms (OR: 0.29, 95% CI: 0.11-0.82, p < 0.05). An active comparator analysis between BNT162b2 and non-SARS-CoV-2 vaccinations revealed that female sex positively influenced the association between BNT162b2 vaccine type and musculoskeletal symptoms.

Conclusions: Sex differences exist in post-vaccination symptoms after BNT162b2 administration even in young children. These are of importance for the conception of approval studies, for post-vaccination monitoring and for future vaccination strategies (German Clinical Trials Register ID: DRKS00028759).

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德国 5 岁以下儿童接种 BNT162b2 mRNA COVID-19 疫苗(CoVacU5)后症状的性别差异:一项回顾性队列研究。
背景:许多疫苗不仅在效力上存在性别差异,在不良反应率上也是如此。在此,我们比较了德国 5 岁以下男女儿童在标签外接种 BNT162b2 疫苗的安全性:这是一项回顾性队列研究,我们对通过认证调查收集的数据集进行了事后分析,调查对象是登记有 0 岁儿童的个人:本次分析的数据集包括 7801 名参与者,其中女性 3842 名(占 49%),男性 3977 名(占 51%),年龄为 3 岁(中位数,四分位数之间为 2 岁)。在接受 3 µg BNT162b2 治疗的患者中,没有发现性别差异,但在首次接受 5-10 µg BNT162b2 治疗后,女孩出现注射部位局部症状的比例高于男孩。在逻辑回归中,女性出现局部症状的几率更高,几率比(OR)为 1.33(95% 置信区间 [CI]:1.15-1.55,P<0.05):1.33(95% 置信区间 [CI]:1.15-1.55,P 结论:接种疫苗后存在性别差异:即使是幼儿,接种 BNT162b2 后的症状也存在性别差异。这对审批研究的构思、疫苗接种后的监测以及未来的疫苗接种策略都具有重要意义(德国临床试验注册编号:DRKS00028759)。
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来源期刊
Biology of Sex Differences
Biology of Sex Differences ENDOCRINOLOGY & METABOLISM-GENETICS & HEREDITY
CiteScore
12.10
自引率
1.30%
发文量
69
审稿时长
14 weeks
期刊介绍: Biology of Sex Differences is a unique scientific journal focusing on sex differences in physiology, behavior, and disease from molecular to phenotypic levels, incorporating both basic and clinical research. The journal aims to enhance understanding of basic principles and facilitate the development of therapeutic and diagnostic tools specific to sex differences. As an open-access journal, it is the official publication of the Organization for the Study of Sex Differences and co-published by the Society for Women's Health Research. Topical areas include, but are not limited to sex differences in: genomics; the microbiome; epigenetics; molecular and cell biology; tissue biology; physiology; interaction of tissue systems, in any system including adipose, behavioral, cardiovascular, immune, muscular, neural, renal, and skeletal; clinical studies bearing on sex differences in disease or response to therapy.
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