HealthDay News — COVID-19 vaccination within the teratogenic window (30 days before conception until 14 weeks of gestation) is not associated with increased odds of major fetal structural anomalies, according to a research letter published online April 4 in JAMA Pediatrics.
Rachel S. Ruderman, M.D., M.P.H., from the Northwestern University Feinberg School of Medicine in Chicago, and colleagues examined the association between COVID-19 vaccination during early pregnancy and the risk for major fetal structural anomalies. The primary analyses compared unvaccinated individuals and those vaccinated outside the teratogenic window to those vaccinated within the teratogenic window. Data were included for 3,156 patients; 83.1% received at least one vaccine dose and 43.8% were vaccinated within the teratogenic window.
The researchers identified a fetal congenital anomaly in 5.1% of unvaccinated people and 4.2% of those who received at least one dose of vaccine. When the teratogenic window was narrowed, the findings were similar. Vaccination within the teratogenic window was not associated with the presence of a congenital anomaly identified on ultrasonography after adjustment for potential confounders (adjusted odds ratio, 1.05; 95% confidence interval, 0.72 to 1.54).
“Given the urgent need for safety data on COVID-19 vaccines, these preliminary findings may be useful when considering vaccination during early pregnancy,” the authors write. “Clinicians may use this evidence in counseling their patients on the safety of vaccination.”
One author served as the site principal investigator for a Pfizer phase 2/3 randomized clinical trial of the COVID-19 vaccine during pregnancy outside the submitted work.