Association of COVID-19 Vaccination During Early Pregnancy With Risk of Congenital Fetal Anomalies

COVID-19 infection increases the risk of maternal and neonatal morbidity in the pregnant population. While data suggest that COVID-19 vaccines are safe and effective during pregnancy, the risk to the fetus is unclear. The aim of this study was to assess the association between COVID-19 vaccination during early pregnancy and the risk of fetal structural anomalies. This was a retrospective cohort study conducted at a single medical center in Chicago. Included were pregnant people with COVID-19 vaccination records, who completed a fetal anatomic survey between March and November 2021. Excluded were pregnancies in which fetal structural anomaly could not be assessed via ultrasound. The teratogenic window was defined as 30 days before conception until 14 weeks of gestation. Pregnant individuals who were vaccinated within this window were compared with those who were unvaccinated or vaccinated outside of the teratogenic window. A total of 3156 individuals met the inclusion criteria, with 1149 vaccinated within the teratogenic window. An anomaly was identified in 5.1% of unvaccinated people versus 4.2% of people who received at least 1 dose of vaccine (P = 0.35). After controlling for confounders, vaccination within the teratogenic window was not associated with the presence of a fetal structural anomaly identified on ultrasound (adjusted odds ratio, 1.05; 95% confidence interval, 0.72-1.54). These preliminary findings suggest that COVID-19 vaccination was not associated with fetal structural anomalies. These findings may be useful to clinicians who counsel patients considering COVID-19 vaccination during pregnancy.