Large cohort study reassures on mRNA vaccine safety for early pregnancies

Large cohort study reassures on mRNA vaccine safety for early pregnancies

Publication date: Jun 11, 2025

In the vaccinated cohort, 32 cases (1. 82%) involved congenital heart defects, compared to 15 cases (0. 87%) in the comparison cohort. While slightly higher rates of congenital heart and urinary tract anomalies were observed in the vaccinated group, no consistent or biologically plausible patterns emerged. The first trimester is a critical window of fetal development, when exposure to potential teratogens can lead to major congenital anomalies. Ventricular septal defects were the most common, with 18 cases in the exposed group and 7 cases in the unexposed group. In six of the exposed cases, vaccination occurred after the 11th gestational week, beyond the period when the fetal heart septum forms, arguing against causality. The adjusted odds ratio for the overall rate of major congenital disabilities was 1. 30 with a 95% confidence interval of 0. 901. 86, indicating no statistically significant increase in risk. Future research should focus on larger cohorts, specific types of defects, and underlying risk factors to further strengthen guidance on vaccination during pregnancy.

Concepts Keywords
German Anomalies
Preterm Cohort
Ureteral Congenital
Vaccines Covid
Group
Major
Mrna
Pregnancy
Pregnant
Risk
Safety
Trimester
Vaccinated
Vaccination
Women

Semantics

Type Source Name
disease MESH Preterm births
disease MESH Patent ductus arteriosus
disease MESH causality
disease MESH Ventricular septal defects
disease MESH congenital heart defects
disease MESH pregnancy outcomes
disease MESH COVID-19
disease MESH Infection
disease IDO ribonucleic acid
disease MESH malformations

Original Article

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