Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Oct;29(10):1306-1312.
doi: 10.1016/j.cmi.2023.06.015. Epub 2023 Jun 19.

Risk of congenital malformation after first trimester mRNA COVID-19 vaccine exposure in pregnancy: the COVI-PREG prospective cohort

Guillaume Favre  1 , Emeline Maisonneuve  2 , Léo Pomar  3 , Charlotte Daire  1 , Cécile Monod  4 , Begoña Martinez de Tejada  5 , Thibaud Quibel  6 , Monya Todesco-Bernasconi  7 , Loïc Sentilhes  8 , Carolin Blume  9 , Andrea Papadia  10 , Stephanie Sturm  11 , Dirk Bassler  12 , Claudia Grawe  13 , Anda Petronela Radan  14 , Marie-Claude Rossier  15 , Jérôme Mathis  16 , Romina Capoccia-Brugger  17 , Karine Lepigeon  1 , Eva Gerbier  1 , Marie Claude Addor  1 , Ursula Winterfeld  18 , David Baud  19 , Alice Panchaud  20 ; COVI-PREG group
Collaborators, Affiliations

Risk of congenital malformation after first trimester mRNA COVID-19 vaccine exposure in pregnancy: the COVI-PREG prospective cohort

Guillaume Favre et al. Clin Microbiol Infect. 2023 Oct.

Abstract

Objectives: This study aimed to evaluate the risk of congenital malformation among pregnant women exposed to the mRNA COVID-19 vaccines during the first trimester of pregnancy, which is a developmental period where the foetus is at risk of teratogenicity.

Methods: Pregnant women were prospectively enrolled from March 2021 to March 2022, at the time of COVID-19 vaccination. Pregnant women exposed to at least one dose of mRNA COVID-19 vaccine from conception to 11 weeks of gestations and 6 days were compared with pregnant women exposed to the vaccine from 12 weeks to the end of pregnancy. The primary outcome was a confirmed congenital malformation at birth.

Results: A total of 1450 pregnant women were enrolled including 124 in the first trimester and 1326 in the second and third trimester. The overall proportion of congenital malformation was 0.81% (n = 1/124; 95% CI: 0.02-4.41) and 0.83% (n = 11/1326; 95% CI: 0.41-1.48) among pregnant exposed to the COVID-19 vaccine during the first and second/third trimester, respectively. First trimester exposure was not associated with a higher risk of congenital malformation with a relative risk of 0.89 (95% CI: 0.12-6.80) with no significant changes after adjustment through exploratory analysis.

Conclusions: Pregnant women exposed to mRNA COVID-19 vaccine before 12 weeks of gestation did not have an increased risk of congenital malformation compared with women exposed outside the teratogenic window. Because vaccination is safe and effective, emphasis must be placed on promoting vaccination during pregnancy.

Keywords: COVID-19; Congenital anomaly; Pregnancy; Pregnant women; SARS-CoV-2; Teratogenicity; Vaccine.

PubMed Disclaimer

Conflict of interest statement

All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf. Alice Panchaud received grants from the Swiss Federal Office of Public Health and the CHUV Foundation; she also received grants from Vifor, the European Medicine Agency (EMA/2017/09/PE and EMA/2017/09/PE/11), the Fonds Paritaire RBP IV and a H2020 grant (ConcePTION WP 3-4), outside the submitted work. Begoña Martinez de Tejada reported receiving financial support from the General Health Division in Geneva, Switzerland, and being a medical advisor for Effik consulting fees and lectures) and Pierre Fabre (consulting fees), outside the submitted work; she also reported having a research agreement for clinical devices with Pregnolia and having been paid as a legal expert in several malpractice cases, outside the submitted work. Loïc Senthiles has been a consultant for Dilafor and Ferring Pharmaceuticals and has received payment in the past for presentations and educational events from Bayer, GlaxoSmithKline, Ferring Pharmaceuticals, and Sigvaris. All other authors declare no conflicts of interest.

References

    1. Office of the Commissioner. FDA Approves First COVID-19 Vaccine [Internet]. FDA. FDA; 2021 [cited 2022 Nov 15]. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-first-c...
    1. EMA. EMA recommends first COVID-19 vaccine for authorisation in the EU [Internet]. European Medicines Agency. 2020 [cited 2022 Nov 15]. Available from: https://www.ema.europa.eu/en/news/ema-recommends-first-covid-19-vaccine-...
    1. Favre G., Pomar L., Baud D. Coronavirus disease 2019 during pregnancy: do not underestimate the risk of maternal adverse outcomes. Am J Obstet Gynecol MFM. 2020 Aug;2(3) - PMC - PubMed
    1. Allotey J., Stallings E., Bonet M., Yap M., Chatterjee S., Kew T., et al. Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta-analysis. BMJ. 2020 Sep 1;370:m3320. - PMC - PubMed
    1. Vouga M., Favre G., Martinez-Perez O., Pomar L., Acebal L.F., Abascal-Saiz A., et al. Maternal outcomes and risk factors for COVID-19 severity among pregnant women. Sci Rep. 2021 Jul 6;11(1) - PMC - PubMed