(8) Association between SARS-CoV-2 vaccine in pregnancy and child neurodevelopment at 18-30 months.

To evaluate whether there is an association between SARS-CoV-2 vaccine in pregnancy and offspring neurodevelopmental measures.

Study Design:
Multi-center prospective observational study of 18-30 month old offspring of mothers who did (exposed) or did not (unexposed) receive at least one dose of an mRNA SARS-CoV-2 vaccine during or within 30 days prior to pregnancy. Exclusions included delivery < 37 weeks, multifetal pregnancy and major congenital malformations. Eligible participants were identified by electronic record review and contacted for consent. Unexposed women were matched with exposed women by delivery site, delivery date, insurance status, and race. The primary outcome was equivalence within an upper and lower margin of 10 points for the Ages and Stages Questionnaire version 3 (ASQ-3) total score. Secondarily, associations with domain-specific ASQ-3 scores as well as Child Behavior Checklist, Modified Checklist for Autism in Toddlers and Early Childhood Behavior Questionnaire scores were evaluated.

Results:
Of 3,956 mothers assessed, 271 exposed and 240 unexposed were enrolled. Matching to unexposed on all characteristics was possible in 217 pairs. The mothers in the exposed group were more likely to be nulliparous, and the children were more likely to be vaccinated and slightly younger at assessment than unexposed (median [IQR] months: 25.4 [24.5,28.1] vs 25.9 [24.7,28.5]; p = 0.03). There were no other significant differences in baseline characteristics. The primary outcome of ASQ score was equivalent between exposed and unexposed (255 vs 260, median difference -3.4, 95% CI: -9.7,3.0; Table 1). No significant differences were noted in secondary outcomes (Table 2).

Conclusion:
The primary neurodevelopmental outcome was equivalent between children of mothers who received and did not receive mRNA SARS-CoV-2 vaccination during or immediately prior to pregnancy. There was no association with secondary neurodevelopmental outcomes. Our results provide reassurance regarding the safety of mRNA SARS-CoV-2 vaccination in pregnancy.