No increase in major congenital anomalies among those exposed to maternal COVID-19 mRNA vaccination during the first trimester was found, according to a recent study.
In the population-based cohort study in Ontario, Canada, published in BMJ Medicine, investigators examined the association between maternal mRNA COVID-19 vaccination during the first trimester and the prevalence of major congenital anomalies in offspring. The study included 174,296 singleton live births beyond 20 weeks’ gestation, with 34,181 (20%) born to mothers who received one or two doses of an mRNA COVID-19 vaccine during the first trimester. A sibling-matched analysis was also performed, comprising 13,312 infants exposed to the vaccine and 15,089 matched older siblings from the same mothers who were unexposed.
The investigators found that the prevalence of major congenital anomalies did not differ significantly between infants exposed to maternal vaccination in the first trimester and those who were unexposed. Specifically, anomalies were noted in 24.3 per 1,000 live births in the vaccinated group and 26.5 per 1,000 in the unvaccinated group, yielding an adjusted prevalence ratio (PR) of 0.89 (95% confidence interval [CI] = 0.79–1.01). The sibling-matched analysis showed similar findings with an adjusted PR of 0.91 (95% CI = 0.77–1.07). No significant increases in anomalies were noted across specific organ systems.
Subgroup and sensitivity analyses were consistent across vaccine type (Pfizer-BioNTech vs Moderna), vaccine dose (one vs two doses), and exposure window adjustments. Vaccinated mothers were more likely to be over age 30 years, live in urban areas, and have prior influenza vaccinations.
The large cohort study provided data indicating no association between first-trimester mRNA COVID-19 vaccination and major congenital anomalies. However, the study emphasized the need for additional data on rare organ-specific anomalies to inform evidence-based decision-making regarding maternal COVID-19 vaccination.
Full disclosures can be found in the published study.