• Agustín Ciapponi, Mabel Berrueta, Jamile Ballivian, Ariel Bardach, Agustina Mazzoni, Steven Anderson, Fernando J Argento, Karin Bok, Daniel Comandé, Erin Goucher, Beate Kampmann, ParkerEdward P KEPKThe Vaccine Centre, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK., Federico Rodriguez-Cairoli, Victoria Santa Maria, Andy Stergachis, Gerald Voss, Xu Xiong, Sabra Zaraa, Flor M Munoz, Ruth A Karron, Sami L Gottlieb, and Pierre M Buekens.
• Instituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Buenos Aires, Argentina.
• Medicine (Baltimore). 2023 Mar 3; 102 (9): e32954e32954.

IntroductionNumerous vaccines have been evaluated and approved for coronavirus disease 2019 (COVID-19). Since pregnant persons have been excluded from most clinical trials of COVID-19 vaccines, sufficient data regarding the safety of these vaccines for the pregnant person and their fetus have rarely been available at the time of product licensure. However, as COVID-19 vaccines have been deployed, data on the safety, reactogenicity, immunogenicity, and efficacy of COVID-19 vaccines for pregnant persons and neonates are becoming increasingly available. A living systematic review and meta-analysis of the safety and effectiveness of COVID-19 vaccines for pregnant persons and newborns could provide the information necessary to help guide vaccine policy decisions.Methods And AnalysisWe aim to conduct a living systematic review and meta-analysis based on biweekly searches of medical databases (e.g., MEDLINE, EMBASE, CENTRAL) and clinical trial registries to systematically identify relevant studies of COVID-19 vaccines for pregnant persons. Pairs of reviewers will independently select, extract data, and conduct risk of bias assessments. We will include randomized clinical trials, quasi-experimental studies, cohort, case-control, cross-sectional studies, and case reports. Primary outcomes will be the safety, efficacy, and effectiveness of COVID-19 vaccines in pregnant persons, including neonatal outcomes. Secondary outcomes will be immunogenicity and reactogenicity. We will conduct paired meta-analyses, including prespecified subgroup and sensitivity analyses. We will use the grading of recommendations assessment, development, and evaluation approach to evaluate the certainty of evidence.Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc.

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