Safety evaluation of COVID-19 vaccination during early pregnancy: A single-center prospective cohort study of Chinese pregnant women

Abstract

ABSTRACT This prospective cohort study aimed to evaluate the safety of an inactivated coronavirus disease 2019 (COVID-19) vaccine in pregnant women at a tertiary hospital in Hubei, China. Pregnancy outcomes were compared between pregnant vaccinated and unvaccinated women. Composite adverse pregnancy outcomes were defined as one or more of maternal adverse outcomes (prenatal pyrexia, postpartum hemorrhage, maternal intensive care unit admission, and a prethrombotic state) and adverse neonatal outcomes (premature delivery, intrauterine fetal death or induction of labor, fetal macrosomia, fetal growth restriction, small-for-gestational age, fetal abnormalities, neonatal admission to the neonatal intensive care unit, and birth asphyxia). Of a total of 845 participants in the delivery cohort, 41.2% (348/845) received at least one dose of the COVID-19 vaccination, and 33.6% (284/845) received two doses. In total, 25.3% (88/348) of the vaccinated group were vaccinated at 0–4 weeks of pregnancy. No significant difference was found in the composite adverse outcomes between the vaccinated and unvaccinated participants, regardless of whether vaccination occurred before (44/243 [18.1%] vs. 71/497 [14.3%]; P = .17) or during early pregnancy (14/105 [13.3%] vs. 71/497[14.3%]; P = .79). These findings indicate that the pregnancy outcomes of women who received the COVID-19 vaccination, even if they were vaccinated early in pregnancy, were comparable to those of unvaccinated women. This study was registered with the Chinese Clinical Trial Center (ChiCTR2100051756).