Coronavirus Disease 2019 (COVID-19) Vaccination and Stillbirth in the Vaccine Safety Datalink.

Autor: Denoble AE; Yale School of Medicine, New Haven, Connecticut; HealthPartners Institute, Bloomington, Minnesota; Baylor College of Medicine, Houston, Texas; Institute for Health Research, Kaiser Permanente Colorado, and Ambulatory Care Services, Denver Health, Denver, Colorado; Kaiser Permanente Southern California, Pasadena, and Kaiser Permanente Vaccine Study Center, Oakland, California; Kaiser Permanente Center for Health Research, Portland, Oregon; Kaiser Permanente, Seattle, Washington; Marshfield Clinic Research Institute, Marshfield, Wisconsin; Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia; and Weill-Cornell School of Medicine, New York, New York., Vazquez-Benitez G, Sheth SS, Ackerman-Banks CM, DeSilva MB, Zhu J, Daley MF, Getahun D, Klein NP, Vesco KK, Irving SA, Nelson J, Williams JTB, Hambidge SJ, Donahue JG, Weintraub ES, Kharbanda EO, Lipkind HS
Jazyk: angličtina
Zdroj: Obstetrics and gynecology [Obstet Gynecol] 2024 Aug 01; Vol. 144 (2), pp. 215-222. Date of Electronic Publication: 2024 Jun 06.
DOI: 10.1097/AOG.0000000000005632
Abstrakt: Objective: Coronavirus disease 2019 (COVID-19) vaccination is recommended in pregnancy to reduce the risk of severe morbidity from COVID-19. However, vaccine hesitancy persists among pregnant people, with risk of stillbirth being a primary concern. Our objective was to examine the association between COVID-19 vaccination and stillbirth.
Methods: We performed a matched case-control study in the Vaccine Safety Datalink (VSD). Stillbirths and live births were selected from singleton pregnancies among persons aged 16-49 years with at least one prenatal, delivery, or postpartum visit at eight participating VSD sites. Stillbirths identified through diagnostic codes were adjudicated to confirm the outcome, date, and gestational age at fetal death. Confirmed antepartum stillbirths that occurred between February 14, 2021, and February 27, 2022, then were matched 1:3 to live births by pregnancy start date, VSD site, and maternal age at delivery. Associations among antepartum stillbirth and COVID-19 vaccination in pregnancy, vaccine manufacturer, number of vaccine doses received, and vaccination within 6 weeks before stillbirth (or index date in live births) were evaluated using conditional logistic regression.
Results: In the matched analysis of 276 confirmed antepartum stillbirths and 822 live births, we found no association between COVID-19 vaccination during pregnancy and stillbirth (38.4% stillbirths vs 39.3% live births in vaccinated individuals, adjusted odds ratio [aOR] 1.02, 95% CI, 0.76-1.37). Furthermore, no association between COVID-19 vaccination and stillbirth was detected by vaccine manufacturer (Moderna: aOR 1.00, 95% CI, 0.62-1.62; Pfizer-BioNTech: aOR 1.00, 95% CI, 0.69-1.43), number of vaccine doses received during pregnancy (1 vs 0: aOR 1.17, 95% CI, 0.75-1.83; 2 vs 0: aOR 0.98, 95% CI, 0.81-1.17), or COVID-19 vaccination within the 6 weeks before stillbirth or index date compared with no vaccination (aOR 1.16, 95% CI, 0.74-1.83).
Conclusion: No association was found between COVID-19 vaccination and stillbirth. These findings further support recommendations for COVID-19 vaccination in pregnancy.
Competing Interests: Financial Disclosure Gabriela Vazquez-Benitez reports AbbVie and Sanofi Pasteur provided research-related funds unrelated to this work to her institution. Sangini Sheth's institution received payment from the NIH, and they received payment from Merck and ACOG. Malini DeSilva's institution received payments from Westat, Inc., and the Minnesota Department of Health. Darios Getahun's institution received payment from the NIH, Garfield Memorial Fund, and Hologic, Inc. Nicola Klein's institution received research support from Pfizer. Money was paid to her institution from Merck and Sanofi Pasteur. Joshua Williams has served as a content reviewer for Immunize 4 Good. Heather Lipkind subcontracted via Health Partners as a consultant for the Vaccine Safety Datalink. Money was paid to her institution from PCORI and Pfizer (external DMSV for COVID-19 vaccination). The other authors did not report any potential conflicts of interest.
(Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)
Databáze: MEDLINE