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. 2021 Mar 1;137(3):408-414.
doi: 10.1097/AOG.0000000000004290.

Coronavirus Disease 2019 (COVID-19) Vaccines and Pregnancy: What Obstetricians Need to Know

Sonja A Rasmussen  1 , Colleen F Kelley, John P Horton, Denise J Jamieson
Affiliations

Coronavirus Disease 2019 (COVID-19) Vaccines and Pregnancy: What Obstetricians Need to Know

Sonja A Rasmussen et al. Obstet Gynecol. .

Erratum in

Abstract

Coronavirus disease 2019 (COVID-19) vaccines have begun to be distributed across the United States and to be offered initially to priority groups including health care personnel and persons living in long-term care facilities. Guidance regarding whether pregnant persons should receive a COVID-19 vaccine is needed. Because pregnant persons were excluded from the initial phase 3 clinical trials of COVID-19 vaccines, limited data are available on their efficacy and safety during pregnancy. After developmental and reproductive toxicology studies are completed, some companies are expected to conduct clinical trials in pregnant persons. Until then, pregnant persons and their obstetricians will need to use available data to weigh the benefits and risks of COVID-19 vaccines. Issues to be considered when counseling pregnant persons include data from animal studies and inadvertently exposed pregnancies during vaccine clinical trials when available, potential risks to pregnancy of vaccine reactogenicity, timing of vaccination during pregnancy, evidence for safety of other vaccines during pregnancy, risk of COVID-19 complications due to pregnancy and the pregnant person's underlying conditions, and risk of exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and potential for risk mitigation. The Centers for Disease Control and Prevention, the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine have each issued guidance supportive of offering COVID-19 vaccine to pregnant persons. As additional information from clinical trials and from data collected on vaccinated pregnant persons becomes available, it will be critical for obstetricians to keep up to date with this information.

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Conflict of interest statement

Financial Disclosure Sonja A. Rasmussen reports serving on the Teva Pregnancy Registry Advisory Committee and the Solriamfetol Pregnancy Registry Advisory Committee. In addition, she serves as a litigation consultant on behalf of Hoffmann-La Roche for a product liability claim regarding an alleged birth defect. These are not relevant to this article or COVID-19. Colleen F. Kelley is supported by research grants to her institution from Gilead Sciences, ViiV, Moderna, and Novavax. The other authors did not report any potential conflicts of interest.

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References

    1. U.S. Food and Drug Administration. Emergency use authorization. Accessed December 13, 2020. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regula...
    1. U.S. Food and Drug Administration. Emergency use authorization for vaccines to prevent COVID-19: guidance for industry—October 2020. Accessed December 13, 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents...
    1. Dooling K, McClung N, Chamberland M, Marin M, Wallace M, Bell BP, et al. The Advisory Committee On Immunization Practices' interim recommendation for allocating initial supplies of COVID-19 vaccine—United States, 2020. MMWR Morb Mortal Wkly Rep 2020;69:1857–9. doi: 10.15585/mmwr.mm6949e1 - DOI - PMC - PubMed
    1. Munoz FM, Sheffield JS, Beigi RH, Read JS, Swamy GK, Jevaji I, et al. Research on vaccines during pregnancy: protocol design and assessment of safety. Vaccine 2013;31:4274–9. doi: 10.1016/j.vaccine.2013.07.042 - DOI - PubMed
    1. U.S. Food and Drug Administration. Pregnant women: scientific and ethical considerations for inclusion in clinical trials guidance for industry—draft guidance. Accessed December 13, 2020. https://www.fda.gov/media/112195/download

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