Purpose: 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. Methods: 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. Results: 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). Conclusions: 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.
CITATION STYLE
de Feijter, M., van Gelder, M. M. H. J., Vissers, L. C. M., Kant, A. C., & Woestenberg, P. J. (2024). The risk of miscarriage after COVID-19 vaccination before and during pregnancy. Pharmacoepidemiology and Drug Safety, 33(1). https://doi.org/10.1002/pds.5724
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