Beschreibung:
<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>Information regarding the risk of early pregnancy COVID‐19 vaccination on the development of major congenital anomalies in the offspring is still limited. Here, we study the association between any COVID‐19 vaccination during the 1st trimester and at least one major non‐genetic congenital anomaly in the offspring.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>We used data from the Dutch Pregnancy Drug Register, an ongoing cohort study. We selected participants with a pregnancy that ended after at least 20 weeks gestation. Pregnant participants self‐reported their COVID‐19 vaccination status and the presence of congenital anomalies in the offspring. We used logistic regression analyses to study the association between 1st trimester COVID‐19 vaccination (gestational week 2 + 0 to 12 + 6) and the risk of at least one major non‐genetic congenital anomaly in the offspring. Clustering of anomalies on the ICD10 level by 1st trimester COVID‐19 vaccination status was explored using Fisher exact tests.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>We included 3721 participants of whom 795 (21.4%) were COVID‐19 vaccinated during the 1st trimester. The percentage of participants who gave birth to a child with at least one major non‐genetic congenital anomaly was comparable between participants who were 1st trimester vaccinated (1.1%) and participants who were not (1.2%) (adjusted odd ratio 0.78 [95% confidence interval 0.35–1.71]). We found no clustering of major non‐genetic congenital anomalies by 1st trimester COVID‐19 vaccination status (<jats:italic>p</jats:italic> > .05).</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>There were no indications of an increased risk of major non‐genetic congenital anomalies in the offspring after maternal 1st trimester COVID‐19 vaccination. Our findings suggest COVID‐19 vaccines are safe during early pregnancy.</jats:p></jats:sec>