Comparison of Adverse Events in Pregnant Persons Receiving COVID-19 and Influenza Vaccines: A Disproportionality Analysis Using Combined Data from US VAERS and EudraVigilance Spontaneous Report Databases.

IF 4 2区医学 Q1 PHARMACOLOGY & PHARMACY

Drug Safety Pub Date : 2025-06-10 DOI:10.1007/s40264-025-01561-6

Leonardo Roque-Pereira, Malede Mequanent Sisay, Comfort K Ogar, Carlos E Durán, Eugene van Puijenbroek, Daniel Weibel, Katia Verhamme, Miriam Sturkenboom

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引用次数: 0

Abstract

Background: Although multiple post-licensure studies demonstrated that coronavirus disease-2019 (COVID-19) vaccines are safe for use during pregnancy, none of them have identified a signal of disproportionate reporting.

Aim: To assess the disproportionality in reported adverse events among pregnant persons receiving COVID-19 vaccination compared with influenza vaccines in spontaneous reporting databases.

Methods: Individual case safety reports (ICSRs) with COVID-19 vaccines (Pfizer, AstraZeneca, Moderna and Johnson & Johnson) and influenza vaccines were retrieved from spontaneous reporting databases in the Vaccine Adverse Event Report System (VAERS) and the EudraVigilance (EV) system between 1 December 2020 and 31 October 2023. Both datasets were combined through a common data model. Pregnancy-associated ICSRs were identified using adaptations to the European Medicines Agency (EMA) algorithm based on age groups and key medical conditions. We compared the disproportionate reporting of High-Level Terms (HLT) after COVID-19 vaccines of interest (e.g. mRNA vaccine) with another COVID-19 viral vector-based/protein subunit and influenza vaccines during pregnancy. The proportional reporting ratio (PRR) with 95% confidence intervals (CIs) was calculated using a combined dataset. PRR met the predefined criteria (PRR ≥ 2, lower 95% CI ≥ 2 and N ≥ 3), confirming a potential signal of disproportionate reporting (SDR).

Results: A total of 22,383 pregnancy-related ICSRs were included. Five associations met the PRR threshold: inborn errors of steroid synthesis 35.1 (95% CI 7.8-158.3); non-site-specific embolism and thrombosis 15.9 (95% CI 3.1-82.2); general signs and symptoms not elsewhere classified (NEC) 11.17 (95% CI 3.3-38.1); peripheral nervous system disorders congenital NEC 4.2 (95% CI 2.3-7.7); and vascular anomalies congenital NEC 3.7 (95% CI 2.4-5.6), all associated with viral vector-based/protein subunit.

Conclusions: Despite this analysis, several statistical disproportionalities were identified during pregnancy; the case-by-case analysis shows that embolism and thrombosis require prioritized investigation through proper causal inference studies.

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接种COVID-19和流感疫苗的孕妇不良事件的比较：使用美国VAERS和eudravigance自发报告数据库联合数据的不比例分析

背景：尽管多项许可后研究表明，2019冠状病毒病（COVID-19）疫苗在妊娠期间使用是安全的，但没有一项研究发现报告不相称的信号。目的：评估在自发报告数据库中接种COVID-19疫苗的孕妇与接种流感疫苗的孕妇报告的不良事件的不相称性。方法：从疫苗不良事件报告系统（VAERS）和EudraVigilance （EV）系统的自发报告数据库中检索2020年12月1日至2023年10月31日期间COVID-19疫苗（辉瑞、阿斯利康、Moderna和强生）和流感疫苗的个案安全性报告（ICSRs）。这两个数据集通过一个公共数据模型组合在一起。根据欧洲药品管理局（EMA）基于年龄组和关键医疗条件的算法，确定了与妊娠相关的icsr。我们比较了妊娠期间COVID-19疫苗（如mRNA疫苗）与另一种基于COVID-19病毒载体/蛋白质亚基和流感疫苗后高级别术语（High-Level Terms， HLT）的不成比例报告。使用组合数据集计算具有95%置信区间（ci）的比例报告比（PRR）。PRR符合预定义标准（PRR≥2,95% CI≤2,N≥3），确认了潜在的不成比例报告（SDR）信号。结果：共纳入22,383例妊娠相关icsr。5种关联符合PRR阈值：类固醇合成先天性错误35.1 (95% CI 7.8-158.3)；非部位特异性栓塞和血栓形成15.9 (95% CI 3.1-82.2)；其他未分类的一般体征和症状（NEC） 11.17 (95% CI 3.3-38.1)；周围神经系统疾病先天性NEC 4.2 (95% CI 2.3-7.7)；先天性NEC 3.7 （95% CI 2.4-5.6）和血管异常，均与基于病毒载体/蛋白质亚基相关。结论：尽管进行了这样的分析，但在怀孕期间发现了一些统计上的不均衡；个案分析表明，栓塞和血栓形成需要通过适当的因果推理研究优先调查。

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

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.