Landmark French Study Confirms COVID-19 mRNA Vaccine Safety in First Trimester of Pregnancy
PARIS, FRANCE – A thorough French study, published in JAMA Network Open today, has definitively found no association between mRNA COVID-19 vaccination during the first trimester of pregnancy and an increased risk of major congenital malformations. The research, analyzing data on over 130,000 pregnancies, provides robust scientific evidence to address lingering concerns and bolster vaccination recommendations for expectant mothers.
The study examined 75 different congenital malformations, employing advanced statistical methods to assess potential links to early-pregnancy mRNA vaccination. Researchers concluded that the data “closes a debate that has remained open for a long time,” confirming the safety of vaccination for the developing fetus.
This finding is particularly significant given ongoing hesitancy surrounding COVID-19 vaccination during pregnancy, despite recommendations from health authorities worldwide. Currently,France,along wiht nearly 200 other countries – including many in Europe – encourage vaccination from the start of pregnancy to protect both mother and child from severe COVID-19 outcomes. The Haute Autorité de Santé (HAS), France’s national health authority, recommends the COVID-19 vaccine as one of four crucial vaccinations for pregnant women, alongside those for influenza, bronchiolitis, and whooping cough. According to HAS guidelines, “In France, vaccination against Covid-19 for pregnant women has been recommended since 2021, during the fall vaccination campaign, regardless of the trimester of pregnancy.”
beyond addressing immediate concerns about COVID-19, the study’s implications extend to the future of mRNA technology. Demonstrating safety during the critical “teratogenic window” – the period when the fetus is most vulnerable to developmental issues – builds confidence in the mRNA platform, which is poised to be utilized against other emerging pathogens.
“This is a strong result, scientifically robust and carries a clear message: early vaccination is safe for the fetus,” the study authors conclude.
Study Details:
* Title: First-Trimester mRNA COVID-19 Vaccination and Risk of Major Congenital anomalies.
* Publication: JAMA Network Open, 2025;8(10):e2538039.doi:10.1001/jamanetworkopen.2025.38039
* Researchers: Bernard C, Duchemin T, Marty L, Drouin J, Miranda S, Semenzato L, Botton J, Chouchana L, Dray-Spira R, Weill A, Zureik M.
* Data Analyzed: Over 130,000 exposed pregnancies, 75 congenital malformations.
Further Research:
this study builds upon existing research,including:
* Shafiee A,Kohandel GargariO,Teymouri,Athar MM,Fathi H,Ghaemi M,Mozhgani SH. COVID-19 vaccination during pregnancy: a systematic review and meta-analysis. BMC Pregnancy Childbirth 2023;23:45.
* Magnus MC, Örtqvist AK, Dahlqwist E, et al. Association of SARS-CoV-2 vaccination during pregnancy with pregnancy outcomes. JAMA 2022;327:146977.
* Magnus MC, Ortqvist AK, Urhoj SK, et al. Infection with SARS-CoV-2 during pregnancy and risk of stillbirth: a Scandinavian registry study. BMJ Public Health 2023.
