This site needs JavaScript to work properly. Please enable it to take advantage of the complete set of features!
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
. 2021 Aug 9;rs.3.rs-798175.
doi: 10.21203/rs.3.rs-798175/v1. Preprint

Receipt of mRNA COVID-19 vaccines preconception and during pregnancy and risk of self-reported spontaneous abortions, CDC v-safe COVID-19 Vaccine Pregnancy Registry 2020-21

Lauren Head Zauche, Bailey Wallace, Ashley N Smoots, Christine K Olson, Titilope Oduyebo, Shin Y Kim, Emily E Peterson, Jun Ju, Jennifer Beauregard, Allen J Wilcox, Charles E Rose, Dana Meaney-Delman, Sascha R Ellington
Free PMC article

Receipt of mRNA COVID-19 vaccines preconception and during pregnancy and risk of self-reported spontaneous abortions, CDC v-safe COVID-19 Vaccine Pregnancy Registry 2020-21

Lauren Head Zauche et al. Res Sq. .
Free PMC article

Abstract

Background There is continuing public concern about the safety of COVID-19 vaccination during pregnancy. While there is no compelling biological reason to expect that mRNA COVID-19 vaccination (either preconception or during pregnancy) presents a risk to pregnancy, data are limited. It is, however, well documented that SARS-CoV-2 infection during pregnancy is associated with severe illness and increased risk of adverse pregnancy outcomes. Among recognized pregnancies in high-income countries, 11-16% end in spontaneous abortion (SAB). Methods People enrolled in v-safe, a voluntary smartphone-based surveillance system, who received a COVID-19 vaccine preconception or during pregnancy were contacted by telephone to enroll in the v-safe pregnancy registry. V-safe pregnancy registry participants who received at least one dose of an mRNA COVID-19 vaccine preconception or prior to 20 weeks' gestation and who did not report a pregnancy loss before 6 completed weeks' gestation were included in this analysis to assess the cumulative risk of SAB using Life Table methods. Results Among 2,456 pregnant persons who received an mRNA COVID-19 vaccine preconception or prior to 20 weeks' gestation, the cumulative risk of SAB from 6-19 weeks' gestation was 14.1% (95% CI: 12.1, 16.1%). Using direct age standardization to the selected reference population, the age-standardized cumulative risk of SAB was 12.8% (95% CI: 10.8-14.8%). Conclusions When compared to the expected range of SABs in recognized pregnancies, these data suggest receipt of an mRNA COVID-19 vaccine preconception or during pregnancy is not associated with an increased risk of SAB. These findings add to accumulating evidence that mRNA COVID-19 vaccines during pregnancy are safe.

Conflict of interest statement

The authors have no conflicts of interest to disclose.

Figures

Figure 1
Figure 1
Inclusion Criteria: Receipt of mRNA COVID-19 vaccines preconception and during pregnancy and risk of self-reported spontaneous abortions, CDC v-safe COVID-19 Vaccine Pregnancy Registry 2020–21
See this image and copyright information in PMC

Comment in

Similar articles

  • mRNA COVID-19 vaccination early in pregnancy and the risk of spontaneous abortion in an international pregnancy registry.
    Mansour O, Hernandez-Diaz S, Wyszynski DF. Mansour O, et al. Pharmacoepidemiol Drug Saf. 2023 Jun;32(6):685-693. doi: 10.1002/pds.5600. Epub 2023 Feb 15. Pharmacoepidemiol Drug Saf. 2023. PMID: 36750979
  • COVID-19 vaccination in pregnancy: early experience from a single institution.
    Trostle ME, Limaye MA, Avtushka V, Lighter JL, Penfield CA, Roman AS. Trostle ME, et al. Am J Obstet Gynecol MFM. 2021 Nov;3(6):100464. doi: 10.1016/j.ajogmf.2021.100464. Epub 2021 Aug 16. Am J Obstet Gynecol MFM. 2021. PMID: 34411758 Free PMC article.
  • Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons.
    Shimabukuro TT, Kim SY, Myers TR, Moro PL, Oduyebo T, Panagiotakopoulos L, Marquez PL, Olson CK, Liu R, Chang KT, Ellington SR, Burkel VK, Smoots AN, Green CJ, Licata C, Zhang BC, Alimchandani M, Mba-Jonas A, Martin SW, Gee JM, Meaney-Delman DM; CDC v-safe COVID-19 Pregnancy Registry Team. Shimabukuro TT, et al. N Engl J Med. 2021 Jun 17;384(24):2273-2282. doi: 10.1056/NEJMoa2104983. Epub 2021 Apr 21. N Engl J Med. 2021. PMID: 33882218 Free PMC article.
  • Safety of inactivated monovalent pandemic (H1N1) 2009 vaccination during pregnancy: a population-based study in Taiwan.
    Huang WT, Tang FW, Yang SE, Chih YC, Chuang JH. Huang WT, et al. Vaccine. 2014 Nov 12;32(48):6463-8. doi: 10.1016/j.vaccine.2014.09.054. Epub 2014 Oct 5. Vaccine. 2014. PMID: 25285884
  • Preexisting Diabetes and Pregnancy.
    Kitzmiller JL, Ferrara A, Peng T, Cissell MA, Kim C. Kitzmiller JL, et al. In: Cowie CC, Casagrande SS, Menke A, Cissell MA, Eberhardt MS, Meigs JB, Gregg EW, Knowler WC, Barrett-Connor E, Becker DJ, Brancati FL, Boyko EJ, Herman WH, Howard BV, Narayan KMV, Rewers M, Fradkin JE, editors. Diabetes in America. 3rd edition. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases (US); 2018 Aug. CHAPTER 5. In: Cowie CC, Casagrande SS, Menke A, Cissell MA, Eberhardt MS, Meigs JB, Gregg EW, Knowler WC, Barrett-Connor E, Becker DJ, Brancati FL, Boyko EJ, Herman WH, Howard BV, Narayan KMV, Rewers M, Fradkin JE, editors. Diabetes in America. 3rd edition. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases (US); 2018 Aug. CHAPTER 5. PMID: 33651557 Free Books & Documents. Review.
See all similar articles

References

    1. Zambrano LD, Ellington SR, Strid P, et al.Update: Characteristics of symptomatic women of reproductive age with laboratory-confirmed SARS-CoV-2 Infection by pregnancy status — United States, January 22–October 3, 2020. MMWR. 2020;69:1641–1647. - PMC - PubMed
    1. Wei SQ, Bilodeau-Bertrand M, Liu S, Auger N. The impact of COVID-19 on pregnancy outcomes: a systematic review and meta-analysis. CMAJ, 2021; 193(16):E540–E548. - PMC - PubMed
    1. Allotey J, Stallings E, Bonet M, 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. - PMC - PubMed
    1. Rossen LM, Ahrens KA, Branum AM. Trends in risk of pregnancy loss among US women, 1990–2011. Paediatr Perinat Epidemiol. 2018;32(1):19–29. - PMC - PubMed
    1. Magnus MC, Wilcox AJ, Morken NH, Weinberg CR, Haberg SE. Role of maternal age and pregnancy history in risk of miscarriage: prospective register based study. BMJ. 2019; 364. - PMC - PubMed

Publication types