Children born to mothers who received mRNA SARS-CoV-2 vaccination during or immediately before pregnancy showed equivalent neurodevelopmental outcomes compared with children of unvaccinated mothers, according to a multicenter prospective observational study conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network and presented at the Society for Maternal-Fetal Medicine meeting.
Investigators enrolled 271 exposed and 240 unexposed mothers, with matching on all characteristics—delivery site, delivery date, insurance status, and race—possible in 217 pairs. Exposed mothers were defined as those who received at least one dose of an mRNA COVID-19 vaccine during pregnancy or within 30 days before conception. The study excluded patients who delivered before 37 weeks' gestation, those with multifetal pregnancies, and cases involving major congenital malformations.
The primary outcome, assessed using the Ages and Stages Questionnaire version 3, showed total scores of 255 in the exposed group vs 260 in the unexposed group, a median difference of -3.4 points. The prespecified equivalence margin was 10 points, and the findings met criteria for equivalence.
Secondary outcomes showed no significant differences across multiple validated tools. Domain-specific ASQ-3 scores—communication, gross motor, fine motor, problem solving, and personal-social—were comparable between groups. The Child Behavior Checklist, Modified Checklist for Autism in Toddlers Revised, and Early Childhood Behavior Questionnaire also revealed no meaningful differences.
Mothers in the exposed group were more likely to be nulliparous, and their children were slightly younger at assessment (median 25.4 vs 25.9 months). No other significant baseline differences emerged.
"Our results provide reassurance regarding the safety of mRNA SARS-CoV-2 vaccination in pregnancy," the investigators concluded.
Author conflicts of interest were not provided in the source abstract.
Source: The full abstract is available from the journal.