First-Trimester mRNA COVID-19 Vaccination and Risk of Major Congenital Anomalies.

ABSTRACT:

Importance

Although messenger RNA (mRNA) COVID-19 vaccines are widely recommended during pregnancy, data on their fetal safety during the teratogenic window remain limited.

Objective

To evaluate the association between first-trimester exposure to mRNA COVID-19 vaccines and the risk of major congenital malformations (MCMs), across 75 individual MCMs grouped by 13 organ systems.

Design, setting, and participants

This nationwide, population-based cohort study was conducted using the comprehensive Mother-Child EPI-MERES Register, including all live-born infants in France from pregnancies starting April 1, 2021, to January 31, 2022. Follow-up data were available up to December 2024.

Exposure

Exposure was defined as receiving at least 1 dose of mRNA-based COVID-19 va

SUBMITTER: Bernard C 

PROVIDER: S-EPMC12529215 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature