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Spontaneous Abortion Following COVID-19 Vaccination During Pregnancy

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

COVID-19 infection during pregnancy can be associated with severe maternal morbidity.1 In the United States, 1 COVID-19 vaccine has been approved and 2 have been authorized for use for pregnant women. To date, data on maternal COVID-19 vaccine safety come primarily from passive surveillance, and studies lack an unvaccinated comparison group.2,3 Spontaneous abortion has been identified as a priority outcome in studies of maternal vaccine safety,4 and concerns regarding risks of spontaneous abortion may be a barrier to vaccination during pregnancy. We present findings from case-control surveillance of COVID-19 vaccination during pregnancy and spontaneous abortion.

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Article Information

Corresponding Author: Elyse O. Kharbanda, MD, MPH, HealthPartners Institute, 8170 33rd Ave S, Mail Stop 23301A, Minneapolis, MN 55408 (elyse.o.kharbanda@healthpartners.com).

Accepted for Publication: August 26, 2021.

Published Online: September 8, 2021. doi:10.1001/jama.2021.15494

Correction: This article was corrected on September 10, 2021, to reverse the transposed column heads in Table 1.

Author Contributions: Drs Kharbanda and Vazquez-Benitez had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Kharbanda, DeSilva, Vazquez-Benitez, Lipkind.

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

Drafting of the manuscript: Kharbanda, Vazquez-Benitez, Lipkind.

Critical revision of the manuscript for important intellectual content: Haapala, DeSilva, Vazquez-Benitez, Vesco, Naleway, Lipkind.

Statistical analysis: Haapala, Vazquez-Benitez.

Obtained funding: Kharbanda.

Supervision: Kharbanda, Lipkind

Conflict of Interest Disclosures: Dr Lipkind reported serving on the Pfizer independent external data monitoring committee for the COVID-19 vaccine. Dr Naleway reported receiving research funding from Pfizer for an unrelated study. Dr Vesco reported receiving research funding from Pfizer for an unrelated study. No other disclosures were reported.

Funding/Support: This study was funded by contract 200-2012-53526 from the Centers for Disease Control and Prevention (CDC).

Role of the Funder/Sponsor: The CDC participated 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 findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the CDC. Mention of a product or company name is for identification purposes only and does not constitute endorsement by the CDC.

Additional Contributions: From the Vaccine Safety Datalink: We thank Nicola Klein, MD, PhD (Kaiser Permanente Northern California), Matthew Daley, MD (Kaiser Permanente Colorado), Darios Getahun, MD (Kaiser Permanente Southern California), Stephanie Irving, MPH (Kaiser Permanente Northwest), Michael Jackson, PhD (Kaiser Permanente Washington), Joshua Williams, MD, Simon Hambidge, MD, PhD (Denver Health), James Donahue, DVM, PhD (Marshfield Clinic), and Candace Fuller, PhD (Harvard Pilgrim) for providing subject matter expertise, technical assistance, assistance with data collection, and review of the study. We thank Leslie Kuckler, MPH, and Jingyi Zhu, PhD (HealthPartners Institute) for their assistance with data collection. We also thank Eric Weintraub (CDC) and Brad Crane (Kaiser Permanente Northwest) for assistance with data collection and management in addition to administrative and technical support. All persons acknowledged have been compensated by the CDC.

References
1.
Ko  JY , DeSisto  CL , Simeone  RM ,  et al.  Adverse pregnancy outcomes, maternal complications, and severe illness among US delivery hospitalizations with and without a coronavirus disease 2019 (COVID-19) diagnosis.   Clin Infect Dis. 2021;73(suppl 1):S24-S31. doi:10.1093/cid/ciab344PubMedGoogle ScholarCrossref
2.
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
3.
Kadali  RAK , Janagama  R , Peruru  SR ,  et al.  Adverse effects of COVID-19 messenger RNA vaccines among pregnant women: a cross-sectional study on healthcare workers with detailed self-reported symptoms.   Am J Obstet Gynecol. Published online Juen 9, 2021. doi:10.1016/j.ajog.2021.06.007PubMedGoogle Scholar
4.
Rouse  CE , Eckert  LO , Babarinsa  I ,  et al; Global Alignment of Immunization Safety in Pregnancy (GAIA) Abortion Work Group; Brighton Collaboration Abortion Working Group.  Spontaneous abortion and ectopic pregnancy: case definition & guidelines for data collection, analysis, and presentation of maternal immunization safety data.   Vaccine. 2017;35(48 pt A):6563-6574. doi:10.1016/j.vaccine.2017.01.047PubMedGoogle ScholarCrossref
5.
Baggs  J , Gee  J , Lewis  E ,  et al.  The Vaccine Safety Datalink: a model for monitoring immunization safety.   Pediatrics. 2011;127(suppl 1):S45-S53. doi:10.1542/peds.2010-1722HPubMedGoogle ScholarCrossref
6.
Naleway  AL , Crane  B , Irving  SA ,  et al.  Vaccine Safety Datalink infrastructure enhancements for evaluating the safety of maternal vaccination.   Ther Adv Drug Saf. 2021;12:20420986211021233. doi:10.1177/20420986211021233PubMedGoogle Scholar
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