What experiences have pregnant and lactating individuals had after the COVID-19 vaccine booster or third dose?
This cohort study of 17 014 participants found that most individuals (82.8%) reported a local reaction and that 67.9% reported at least 1 systemic symptom after a COVID-19 vaccine booster or third dose. Most pregnant (97.6%) and lactating (96.0%) individuals reported no obstetric or lactation concerns after vaccination.
This study suggests that the COVID-19 vaccine booster or third dose was well tolerated among pregnant and lactating individuals.
COVID-19 vaccine boosters or third doses are recommended for adolescents and adults who completed their initial COVID-19 vaccine course more than 5 months prior. Minimal data are available on COVID-19 vaccine booster or third dose reactogenicity among pregnant and lactating individuals.
To describe the reactions to the booster or third dose of the COVID-19 vaccine and vaccine experiences among pregnant and lactating individuals.
Design, Setting, and Participants
Beginning in October 2021, a follow-up Research Electronic Data Capture (REDCap) survey regarding a COVID-19 vaccine booster or third dose was sent to 17 504 participants in an ongoing online prospective cohort study on COVID-19 vaccines among pregnant and lactating individuals. A convenience sample of adults enrolled in the online prospective study who were pregnant, lactating, or neither pregnant nor lactating at the time of their booster or third dose was eligible for this follow-up survey; 17 014 (97.2%) completed the follow-up survey.
Receipt of a booster or third dose of the COVID-19 vaccine.
Main Outcomes and Measures
Self-reported vaccine reactions less than 24 hours after the dose.
As of April 4, 2022, 17 014 eligible participants (mean [SD] age, 33.3 [3.5] years) responded to the booster or third dose survey; of these, 2009 (11.8%) were pregnant at the time of their booster or third dose, 10 279 (60.4%) were lactating, and 4726 (27.8%) were neither pregnant nor lactating. After a COVID-19 booster or third dose, most individuals (14 074 of 17 005 [82.8%]) reported a local reaction, and 11 542 of 17 005 (67.9%) reported at least 1 systemic symptom. Compared with individuals who were neither pregnant nor lactating, pregnant participants were more likely to report any local reaction to a COVID-19 booster or third dose (adjusted odds ratio [aOR], 1.2; 95% CI, 1.0-1.4; P = .01) but less likely to report any systemic reaction (aOR, 0.7; 95% CI, 0.6-0.8; P < .001). Most pregnant (1961 of 2009 [97.6%]) and lactating (9866 of 10 277 [96.0%]) individuals reported no obstetric or lactation concerns after vaccination.
Conclusions and Relevance
This study suggests that COVID-19 vaccine boosters or third doses were well tolerated among pregnant and lactating individuals. Data to evaluate tolerability of boosters or additional doses among pregnant and lactating individuals will be important as they are considered for these populations.
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Accepted for Publication: July 22, 2022.
Published: September 8, 2022. doi:10.1001/jamanetworkopen.2022.30495
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2022 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 (email@example.com).
Author Contributions: Drs Kachikis and Singleton 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: Kachikis, Englund, Eckert.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Kachikis, Englund, Covelli, Frank, Haghighi, Drake.
Critical revision of the manuscript for important intellectual content: Kachikis, Englund, Singleton, Drake, Eckert.
Statistical analysis: Kachikis, Singleton, Drake.
Obtained funding: Kachikis.
Administrative, technical, or material support: Englund, Covelli, Frank, Haghighi, Eckert.
Supervision: Englund, Eckert.
Conflict of Interest Disclosures: Dr Kachikis reported serving as a research consultant for Pfizer and GlaxoSmithKline on maternal immunization-related projects in 2020 and as an unpaind consultant for GlaxoSmithKline in 2022 outside the submitted work. Drs Kachikis, Englund, and Drake reported receiving grant support from Merck outside the submitted work. Drs Kachikis and Englund reported receiving grant support from Pfizer outside the submitted work. Dr Englund reported receiving grant support from GlaxoSmithKline and AstraZeneca and serving as a consultant for AstraZeneca, Moderna, Sanofi Pasteur, and Meissa Vaccines Inc outside the submitted work. No other disclosures were reported.
Funding/Support: This project was supported by grant K23 AI153390-01 from the National Institute of Allergy and Infectious Diseases, a 2 K12HD001264-21 Women’s Reproductive Health Research Award, and by the National Center for Advancing Translational Sciences of the National Institutes of Health under Award UL1 TR002319 for the purposes of 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.
Role of the Funder/Sponsor: The funding sources 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 the individuals who participated in and contributed their valuable time to this study.
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