Overview
- A JAMA Network Open analysis of roughly 500,000 live-born infants found 176.6 major congenital malformations per 10,000 after first-trimester mRNA exposure versus 179.4 per 10,000 unexposed, a nonsignificant difference.
- No safety signal appeared by organ system, and stillbirth rates were identical at 0.4% in vaccinated and unvaccinated pregnancies.
- The cohort used France’s Mother-Child EPI-MERES register for pregnancies beginning April 2021 to January 2022, focusing on Pfizer-BioNTech and Moderna vaccines.
- Exposure was defined as vaccination from conception through day 91 of pregnancy, with non-mRNA products excluded and known teratogenic exposures removed.
- Authors note limits including the inclusion of live births only, and the findings arrive as the U.S. government has pulled back previous pregnancy vaccine recommendations.