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. 2025 May 2;146(1):129-137.
doi: 10.1097/AOG.0000000000005904.

Coronavirus Disease 2019 (COVID-19) Vaccination and Spontaneous Abortion

Sangini S Sheth  1 , Gabriela Vazquez-Benitez, Malini B DeSilva, Jingyi Zhu, Elisabeth M Seburg, Anna E Denoble, Matthew F Daley, Darios Getahun, Nicola P Klein, Kimberly K Vesco, Stephanie A Irving, Jennifer C Nelson, Joshua T B Williams, Simon J Hambidge, James G Donahue, Heather S Lipkind, Elyse O Kharbanda
Affiliations

Coronavirus Disease 2019 (COVID-19) Vaccination and Spontaneous Abortion

Sangini S Sheth et al. Obstet Gynecol. .

Abstract

Objective: To examine the association between coronavirus disease 2019 (COVID-19) vaccination and spontaneous abortion.

Methods: We conducted a case-control study of clinically adjudicated spontaneous abortions (case group) occurring between January 19, 2021, and October 27, 2021, and live births (control group). Patients aged 16-49 years at eight Vaccine Safety Datalink sites who had singleton pregnancies, one or more prenatal visits, continuous health plan enrollment, and spontaneous abortion (fetal loss between 6 and less than 20 weeks of gestation) or live birth were eligible. A random sample of eligible patients with spontaneous abortions was adjudicated to confirm pregnancy outcome, outcome date, and gestational age at fetal death; patients in the adjudicated spontaneous abortion case group were matched 1:2 on Vaccine Safety Datalink site, maternal age, and pregnancy start date with eligible patients with live births. Vaccine exposure was considered from pregnancy start to spontaneous abortion date or equivalent gestational age for the matched live births (index date). Conditional logistic regression was used to evaluate the association between COVID-19 vaccination in pregnancy and spontaneous abortion; secondary analyses explored associations by dose number, vaccine manufacturer, and vaccination within 6 weeks of the spontaneous abortion.

Results: Matched analyses included 296 patients in the spontaneous abortion case group and 592 in the live birth control group. There was no association between spontaneous abortion and COVID-19 vaccination (adjusted odds ratio [aOR] 0.85, 95% CI, 0.56-1.30). There was also no association between spontaneous abortion and dose number compared with no vaccine (one dose: aOR 0.81, 95% CI, 0.39-1.70; two doses: aOR 0.84, 95% CI, 0.51-1.38; vaccine manufacturer: Moderna aOR 0.59, 95% CI, 0.29-1.19 and Pfizer-BioNTech aOR 0.97, 95% CI, 0.57-1.66; or vaccine exposure window of 6 weeks before spontaneous abortion or index date: aOR 0.87, 95% CI, 0.53-1.44).

Conclusion: There was no observed association between COVID-19 vaccination in pregnancy and spontaneous abortion. Findings support the safety of COVID-19 vaccination in early pregnancy.

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Conflict of interest statement

Financial Disclosure Gabriela Vazquez-Benitez receives research support from AbbVie and Sanofi for unrelated related studies. Malini B. DeSilva and Stephanie A. Irving's institutions received funding from Westat, Inc. Elisabeth M. Seburg receives research support from Sanofi for an unrelated study. Darios Getahun receives research support from Garfield Memorial Fund, Johnson & Johnson, and HOLOGIC Inc for unrelated studies. Nicola P. Klein has received research support from Pfizer for COVID-19 vaccine clinical trials, and from Pfizer, Sanofi, GlaxoSmithKline, Merck, Seqirus, Moderna, and AstraZeneca for unrelated studies. Jennifer C. Nelson has served as a statistical consultant on vaccine safety methods for Acumen LLC and Harvard Pilgrim Health Care for unrelated studies. Joshua T.B. Williams received payments from Immunize Colorado and the Colorado Department of Public Health and Environment. Heather S. Lipkind has previously served on the DSMB for the Pfizer COVID-19 vaccine. The other authors did not report any potential conflicts of interest.

References

    1. Oliver SE, Gargano JW, Marin M, Wallace M, Curran KG, Chamberland M, et al. The Advisory Committee on Immunization Practices' interim recommendation for use of Pfizer-BioNTech COVID-19 vaccine—United States, December 2020. MMWR Morb Mortal Wkly Rep 2020;69:1922–4. doi: 10.15585/mmwr.mm6950e2 - DOI - PMC - PubMed
    1. Beigi RH, Krubiner C, Jamieson DJ, Lyerly AD, Hughes B, Riley L, et al. The need for inclusion of pregnant women in COVID-19 vaccine trials. Vaccine 2021;39:868–70. doi: 10.1016/j.vaccine.2020.12.074 - 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. Rasmussen SA, Jamieson DJ. COVID-19 vaccination during pregnancy—two for the price of one. N Engl J Med 2022;387:178–9. doi: 10.1056/NEJMe2206730 - DOI - PMC - PubMed
    1. Ellington S, Strid P, Tong VT, Woodworth K, Galang RR, Zambrano LD, et al. Characteristics of women of reproductive age with laboratory-confirmed SARS-CoV-2 infection by pregnancy status—United States, January 22–June 7, 2020. MMWR Morb Mortal Wkly Rep 2020;69:769–75. doi: 10.15585/mmwr.mm6925a1 - DOI - PMC - PubMed

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