Coronavirus Disease 2019 (COVID-19) Vaccines and Pregnancy: What Obstetricians Need to Know
-
-
Affiliations
- PMID: 33370015
- DOI: 10.1097/AOG.0000000000004290
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.
Copyright © 2020 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.
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.
Similar articles
-
[Technical guidelines for seasonal influenza vaccination in China (2020-2021)].
Zhonghua Yu Fang Yi Xue Za Zhi. 2020 Oct 6;54(10):1035-1059. doi: 10.3760/cma.j.cn112150-20200911-01198.PMID: 33131228 Chinese. -
Coronavirus Disease 2019 (COVID-19) and pregnancy: what obstetricians need to know.
Am J Obstet Gynecol. 2020 May;222(5):415-426. doi: 10.1016/j.ajog.2020.02.017. Epub 2020 Feb 24.PMID: 32105680 Free PMC article. Review. -
[Technical guidelines for seasonal influenza vaccination in China (2020-2021)].
Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Oct 10;41(10):1555-1576. doi: 10.3760/cma.j.cn112338-20200904-01126.PMID: 33297613 Chinese. -
Considerations for Pregnant Dental and Health Care Workers amid COVID-19.
JDR Clin Trans Res. 2020 Oct;5(4):300-306. doi: 10.1177/2380084420952747. Epub 2020 Aug 18.PMID: 32810408 Review.
References
-
- U.S. Food and Drug Administration. Emergency use authorization. Accessed December 13, 2020. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regula…
-
- 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…
-
- 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
-
- 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
-
- 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
-