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

Are messenger RNA (mRNA)–based COVID-19 vaccines teratogenic ?In this nationwide cohort study of 527 564 live-born infants, 130 338 (24.7%) were exposed to an mRNA-based COVID-19 vaccine during the first trimester of pregnancy. There was no association with an increased risk for 75 different major congenital malformations, whether examined overall, grouped by organ systems, or individually.These findings suggest that mRNA-based COVID-19 vaccines do not appear to have any teratogenic effects.

Corresponding Authors: Clément Bernard, MSc (clement.bernard@ansm.sante.fr), and Mahmoud Zureik, MD, PhD (mahmoud.zureik@ansm.sante.fr), EPI-PHARE Scientific Interest Group in Epidemiology of Health Products, 143/147 Bd Anatole, 93285 Saint-Denis, Cedex, France.

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