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
. 2024 Jun 1;143(6):794-802.
doi: 10.1097/AOG.0000000000005583. Epub 2024 Apr 17.

Obstetric Complications and Birth Outcomes After Antenatal Coronavirus Disease 2019 (COVID-19) Vaccination

Kimberly K Vesco  1 , Anna E Denoble, Heather S Lipkind, Elyse O Kharbanda, Malini B DeSilva, Matthew F Daley, Darios Getahun, Ousseny Zerbo, Allison L Naleway, Lisa Jackson, Joshua T B Williams, Thomas G Boyce, Candace C Fuller, Eric S Weintraub, Gabriela Vazquez-Benitez
Affiliations

Obstetric Complications and Birth Outcomes After Antenatal Coronavirus Disease 2019 (COVID-19) Vaccination

Kimberly K Vesco et al. Obstet Gynecol. .

Abstract

Objective: To evaluate the association between antenatal messenger RNA (mRNA) coronavirus disease 2019 (COVID-19) vaccination and risk of adverse pregnancy outcomes.

Methods: This was a retrospective cohort study of individuals with singleton pregnancies with live deliveries between June 1, 2021, and January 31, 2022, with data available from eight integrated health care systems in the Vaccine Safety Datalink. Vaccine exposure was defined as receipt of one or two mRNA COVID-19 vaccine doses (primary series) during pregnancy. Outcomes were preterm birth (PTB) before 37 weeks of gestation, small-for-gestational age (SGA) neonates, gestational diabetes mellitus (GDM), gestational hypertension, and preeclampsia-eclampsia-HELLP (hemolysis, elevated liver enzymes, and low platelet count) syndrome. Outcomes in individuals vaccinated were compared with those in propensity-matched individuals with unexposed pregnancies. Adjusted hazard ratios (aHRs) and 95% CIs were estimated for PTB and SGA using a time-dependent covariate Cox model, and adjusted relative risks (aRRs) were estimated for GDM, gestational hypertension, and preeclampsia-eclampsia-HELLP syndrome using Poisson regression with robust variance.

Results: Among 55,591 individuals eligible for inclusion, 23,517 (42.3%) received one or two mRNA COVID-19 vaccine doses during pregnancy. Receipt of mRNA COVID-19 vaccination varied by maternal age, race, Hispanic ethnicity, and history of COVID-19. Compared with no vaccination, mRNA COVID-19 vaccination was associated with a decreased risk of PTB (rate: 6.4 [vaccinated] vs 7.7 [unvaccinated] per 100, aHR 0.89; 95% CI, 0.83-0.94). Messenger RNA COVID-19 vaccination was not associated with SGA (8.3 vs 7.4 per 100; aHR 1.06, 95% CI, 0.99-1.13), GDM (11.9 vs 10.6 per 100; aRR 1.00, 95% CI, 0.90-1.10), gestational hypertension (10.8 vs 9.9 per 100; aRR 1.08, 95% CI, 0.96-1.22), or preeclampsia-eclampsia-HELLP syndrome (8.9 vs 8.4 per 100; aRR 1.10, 95% CI, 0.97-1.24).

Conclusion: Receipt of an mRNA COVID-19 vaccine during pregnancy was not associated with an increased risk of adverse pregnancy outcomes; this information will be helpful for patients and clinicians when considering COVID-19 vaccination in pregnancy.

PubMed Disclaimer

Conflict of interest statement

Financial Disclosure Kimberly K. Vesco's travel to the American Diabetes Association Meeting to present the research was covered by grant funds from the CDC. She received an Independent Grant for Learning and Change (Grant # 42360015), funded by Pfizer, Inc., and paid to her institution, to develop a novel menopause curriculum for medical residents. Darios Getahun's institution received funding from Hologic, Inc. and Johnson & Johnson. Candace C. Fuller is employed at Harvard Pilgrim Health Care institute, a non-profit organization that conducts work for government and private organizations, including pharmaceutical companies. Gabriela Vazquez-Benitez has received research funding from Sanofi Pasteur and AbbVie for unrelated work. Thomas Boyce has received grants from Pfizer, Moderna, and GlaxoSmithKline for unrelated research. The other authors did not report any potential conflicts of interest.

Figures

Fig. 1.
Fig. 1.. Flowchart of Vaccine Safety Datalink pregnancies eligible for outcome-specific analyses. EDD, estimated date of delivery; COVID-19, coronavirus disease 2019.
Fig. 2.
Fig. 2.. Standardized mean difference (SMD) plot for the full cohort before and after inverse probability weighting. PNC, prenatal care; CVD, cardiovascular disease; COVID-19, coronavirus disease 2019; Prop Score, propensity score.
See this image and copyright information in PMC

References

    1. Metz TD, Clifton RG, Hughes BL, Sandoval GJ, Grobman WA, Saade GR, et al. Association of SARS-CoV-2 infection with serious maternal morbidity and mortality from obstetric complications. JAMA 2022;327:748–59. doi: 10.1001/jama.2022.1190 - DOI - PMC - PubMed
    1. Metz TD, Clifton RG, Hughes BL, Sandoval G, Saade GR, Grobman WA, et al. Disease severity and perinatal outcomes of pregnant patients with coronavirus disease 2019 (COVID-19). Obstet Gynecol 2021;137:571–80. doi: 10.1097/AOG.0000000000004339 - DOI - 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;370:m3320. doi: 10.1136/bmj.m3320 - DOI - PMC - PubMed
    1. Gurol-Urganci I, Jardine JE, Carroll F, Draycott T, Dunn G, Fremeaux A, et al. Maternal and perinatal outcomes of pregnant women with SARS-CoV-2 infection at the time of birth in England: national cohort study. Am J Obstet Gynecol 2021;225:522 e1–11. doi: 10.1016/j.ajog.2021.05.016 - DOI - PMC - PubMed
    1. Centers for Disease Control and Prevention. COVID-19 vaccines while pregnant or breastfeeding. Accessed February 15, 2023. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregn...