Objective:

To assess neurodevelopmental outcomes in children born to mothers who received mRNA SARS-CoV-2 vaccination during or immediately before pregnancy.

Key Findings:

• Total ASQ scores: 255 in exposed group vs 260 in unexposed group, with a median difference of -3.4 points.
• Prespecified equivalence margin was 10 points; findings met criteria for equivalence.
• No significant differences in secondary outcomes across multiple validated tools.

Interpretation:

The study provides reassurance regarding the safety of mRNA SARS-CoV-2 vaccination in pregnancy, showing no adverse effects on neurodevelopmental outcomes.

Limitations:

• Potential biases due to observational study design.
• Conflicts of interest were not disclosed.

Conclusion:

The results support the safety of mRNA COVID-19 vaccination during pregnancy with respect to child neurodevelopment.