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Short-term Reactions Among Pregnant and Lactating Individuals in the First Wave of the COVID-19 Vaccine Rollout

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To identify the key insights or developments described in this article
1 Credit CME

Vaccines against SARS-CoV-2 are highly effective in preventing COVID-19 illness.1,2 Research has found that COVID-19 is associated with adverse events in pregnancy,3 and recommendations therefore include offering SARS-CoV-2 vaccines to pregnant and lactating individuals, despite their lack of inclusion in initial clinical trials.4,5 To date, limited data on vaccine and pregnancy outcomes exist for SARS-CoV-2 vaccines in pregnancy and lactation.6 The objective of this study was to investigate experiences of pregnant and lactating individuals after receiving COVID-19 vaccines.

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Article Information

Accepted for Publication: June 11, 2021.

Published: August 17, 2021. doi:10.1001/jamanetworkopen.2021.21310

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 Kachikis A et al. JAMA Network Open.

Corresponding Author: Alisa Kachikis, MD, MS, Department of Obstetrics and Gynecology, University of Washington, 1959 NE Pacific St, Box 356460, Seattle, WA 98195 (abk26@uw.edu).

Author Contributions: Drs Kachikis and Singleton had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Kachikis, Eckert.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Kachikis, Englund, Drake.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Kachikis, Singleton, Drake.

Obtained funding: Kachikis.

Administrative, technical, or material support: Kachikis, Englund, Covelli, Drake, Eckert.

Supervision: Kachikis, Eckert.

Conflict of Interest Disclosures: Drs. Kachikis, Drake, and Englund reported receiving grants from Merck outside the submitted work. Dr Kachikis reported serving as a research consultant for Pfizer and GlaxoSmithKline on maternal immunization–related projects in 2020 outside the submitted work. Dr Englund reported receiving consulting fees from Sanofi Pasteur, Meissa Vaccines, and AstraZeneca and grants from Pfizer, GlaxoSmithKline, AstraZeneca, Novavax, and Chimerix outside the submitted work. No other disclosures were reported.

Funding/Support: This project was supported by Women’s Reproductive Health Research grant K12HD001264-21 through the National Institute of Child Health and Human Development, grant K23AI153390-01A1 through the National Institute of Allergy and Infectious Diseases, and grant UL1 TR002319 from the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health for the purposes of design and conduct of the study and collection, management, analysis, and interpretation of data. The UW Institute of Translational Health Science provided administrative Research Electronic Data Capture support for this project and was supported by grants UL1 TR002319, KL2 TR002317, and TL1 TR002318 from NCATS.

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Additional Contributions: We would like to acknowledge foremost the individuals who contributed their valuable time to this study.

References
1.
Pfizer and BioNTech. Pfizer and BioNTech conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting all primary efficacy endpoints. Accessed July 9, 2021. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine
2.
Moderna. Moderna announces primary efficacy analysis in phase 3 COVE Study for its COVID-19 Vaccine Candidate and Filing today with U.S. FDA for Emergency Use Authorization. Accessed July 9, 2021. https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-primary-efficacy-analysis-phase-3-cove-study
3.
Delahoy  MJ , Whitaker  M , O’Halloran  A ,  et al; COVID-NET Surveillance Team.  Characteristics and maternal and birth outcomes of hospitalized pregnant women with laboratory-confirmed COVID-19—COVID-NET, 13 states, March 1-August 22, 2020.   MMWR Morb Mortal Wkly Rep. 2020;69(38):1347-1354. doi:10.15585/mmwr.mm6938e1PubMedGoogle ScholarCrossref
4.
American College of Obstetricians and Gynecologists. COVID-19 vaccination considerations for obstetric–gynecologic care: practice advisory. Updated July 2, 2021. Accessed July 13, 2021. https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2020/12/vaccinating-pregnant-and-lactating-patients-against-covid-19
5.
Centers for Disease Control and Prevention. COVID-19 vaccines while pregnant or breastfeeding. Updated June 29, 2021. Accessed July 13, 2021. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregnancy.html
6.
Shimabukuro  TT , Kim  SY , Myers  TR ,  et al; CDC v-safe COVID-19 Pregnancy Registry Team.  Preliminary findings of mRNA covid-19 vaccine safety in pregnant persons.   N Engl J Med. 2021;384(24):2273-2282. doi:10.1056/NEJMoa2104983PubMedGoogle ScholarCrossref
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