Safety, immunogenicity, and effectiveness of COVID-19 vaccines for pregnant persons: A protocol for systematic review and meta analysis

• Published in: Medicine (Baltimore) 2023-03, Vol.102 (9), p.e32954-e32954
• Main Authors: Ciapponi, Agustín, Berrueta, Mabel, Ballivian, Jamile, Bardach, Ariel, Mazzoni, Agustina, Anderson, Steven, Argento, Fernando J., Bok, Karin, Comandé, Daniel, Goucher, Erin, Kampmann, Beate, Parker, Edward P. K., Rodriguez-Cairoli, Federico, Santa Maria, Victoria, Stergachis, Andy, Voss, Gerald, Xiong, Xu, Zaraa, Sabra, Munoz, Flor M., Karron, Ruth A., Gottlieb, Sami L., Buekens, Pierre M.
• Format: Article
• Language: English
• Subjects: COVID-19 - prevention & control; COVID-19 Vaccines - adverse effects; Cross-Sectional Studies; Databases, Factual; Female; Fetus; Humans; Infant, Newborn; Meta-Analysis as Topic; Pregnancy
• ISSN: 0025-7974; 1536-5964; 1536-5964
• DOI: 10.1097/MD.0000000000032954

Numerous 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. We 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.