Affiliation:
1. Netherlands Pharmacovigilance Centre Lareb 's‐Hertogenbosch The Netherlands
2. Department for Health Evidence Radboud University Medical Center Nijmegen The Netherlands
3. Department of Clinical Pharmacology and Toxicology Leiden University Medical Centre Leiden The Netherlands
Abstract
AbstractPurposePregnant 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.MethodsIn 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.ResultsA 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).ConclusionsWe 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.
Funder
Ministerie van Volksgezondheid, Welzijn en Sport
Subject
Pharmacology (medical),Epidemiology
Cited by
3 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献