第一个季度的mRNACOVID-19疫苗接种和重大先天性异常的风险
Clément Bernard1,2, Tom Duchemin1, Lise Marty1
1EPI-PHARE Scientific Interest Group in Epidemiology of Health Products, French National Agency for Medicines and Health Products Safety (ANSM) and French National Health Insurance (CNAM), Saint-Denis, France.
JAMA network open
|October 15, 2025
概括
在怀孕期间接种COVID-19疫苗的第一季度信使RNA (mRNA) 没有增加重大先天性形 (MCM) 的风险. 这项研究支持mRNA COVID-19疫苗在怀孕早期的安全性.
科学领域:
- 产科和妇科 产科和妇科
- 疫苗学 疫苗学 疫苗学
- 儿科健康 儿科健康
背景情况:
- 在怀孕期间建议使用信使RNA (mRNA) COVID-19疫苗.
- 有限的数据存在胎儿安全在早期怀孕的关键产性窗口期间.
研究的目的:
- 评估第一季度mRNACOVID-19疫苗暴露与重大先天性形 (MCMs) 之间的关联.
- 评估75个单独的MCM和13个器官系统的风险.
主要方法:
- 全国范围,基于人口的队列研究,使用法国的母婴EPI-MERES注册表.
- 包括从2021年4月到2022年1月的怀孕中活产的婴儿.
- 倾向性得分权重和后勤回归以调整混因素并估计赔率比率.
主要成果:
- 超过13万名婴儿在第一季度接受了mRNA COVID-19疫苗接种.
- 总体而言,没有观察到MCM的风险增加 (加权OR,0.98).
- 没有发现器官系统或单个MCM的风险增加.
结论:
- 第一季度接触mRNA COVID-19疫苗并没有增加重大先天性形的风险.
- 这些发现支持mRNACOVID-19疫苗在怀孕早期的安全性.
- 让医疗保健提供者和孕妇对接种疫苗的安全性感到放心.
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