Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
Department for Health Evidence, Radboud University Medical Center, Nijmegen, The Netherlands.
Pharmacoepidemiol Drug Saf. 2024 Jan;33(1):e5724. doi: 10.1002/pds.5724. Epub 2023 Nov 9.
Pregnant women are at higher risk of severe illness and adverse pregnancy outcomes due to a SARS-CoV-2 infection, which can be prevented by vaccination. Observational studies are needed to ascertain the safety of COVID-19 vaccination during pregnancy. We aimed to determine whether COVID-19 vaccination before and during pregnancy is associated with the risk of miscarriage.
In this cohort study, we included 4640 pregnant women (mean age: 32.8 ± 3.7 years) from the Dutch Pregnancy Drug Register between February 2021 and August 2022. Information on COVID-19 vaccinations, miscarriage, and confounders was self-reported, using web-based questionnaires. The hazard ratio (HR) of miscarriage (in gestational weeks 6-20) after a COVID-19 vaccination, was estimated using the survival analyses. A COVID-19 vaccination during pregnancy (≥1 COVID-19 vaccination between week 2 and 20 of pregnancy) was included as a time-dependent exposure and vaccination prior to pregnancy was included as a binary exposure.
A total of 3202 pregnant women (69%) received ≥1 COVID-19 vaccine in gestational week 2-20. We observed no association of vaccination during pregnancy with the risk of miscarriage (adjusted HR = 1.29, 95% CI = 0.93-1.74). Vaccination prior to pregnancy, however, was associated with a decreased risk of miscarriage (adjusted HR = 0.69, 95% CI = 0.48-0.99).
We demonstrated that COVID-19 vaccination during pregnancy is not associated with an increased risk of miscarriage in gestational weeks 6-20. This study adds to the growing body of evidence demonstrating the safety of COVID-19 vaccination during pregnancy.
由于 SARS-CoV-2 感染,孕妇患重病和不良妊娠结局的风险更高,而疫苗接种可预防这种情况。需要进行观察性研究以确定 COVID-19 疫苗在怀孕期间的安全性。我们旨在确定 COVID-19 疫苗在怀孕前和怀孕期间接种是否与流产风险相关。
在这项队列研究中,我们纳入了 2021 年 2 月至 2022 年 8 月期间来自荷兰妊娠药物登记处的 4640 名孕妇(平均年龄:32.8±3.7 岁)。使用基于网络的问卷,自我报告 COVID-19 疫苗接种、流产和混杂因素的信息。使用生存分析估计 COVID-19 疫苗接种(妊娠第 6-20 周)后流产的风险比(HR)。将妊娠期间的 COVID-19 疫苗接种(妊娠第 2-20 周之间至少接种 1 剂 COVID-19 疫苗)作为时间依赖性暴露因素,将妊娠前的疫苗接种作为二分类暴露因素。
共有 3202 名孕妇(69%)在妊娠第 2-20 周接受了至少 1 剂 COVID-19 疫苗。我们未观察到妊娠期间接种疫苗与流产风险增加相关(调整后的 HR=1.29,95%CI=0.93-1.74)。然而,妊娠前的疫苗接种与流产风险降低相关(调整后的 HR=0.69,95%CI=0.48-0.99)。
我们表明,妊娠期间接种 COVID-19 疫苗与妊娠第 6-20 周的流产风险增加无关。本研究增加了越来越多的证据,证明 COVID-19 疫苗在怀孕期间的安全性。