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

Ciapponi, AgustínORCID logo; Berrueta, Mabel; Ballivian, Jamile; Bardach, Ariel; Mazzoni, Agustina; Anderson, Steven; Argento, Fernando J; Bok, Karin; Comandé, Daniel; Goucher, Erin; +12 more...Kampmann, BeateORCID logo; Parker, Edward PKORCID logo; Rodriguez-Cairoli, Federico; Santa Maria, Victoria; Stergachis, Andy; Voss, Gerald; Xiong, Xu; Zaraa, Sabra; Munoz, Flor M; Karron, Ruth A; Gottlieb, Sami L; and Buekens, Pierre M (2023) Safety, immunogenicity, and effectiveness of COVID-19 vaccines for pregnant persons: A protocol for systematic review and meta analysis. Medicine, 102 (9). e32954-. ISSN 0304-5412 DOI: 10.1097/MD.0000000000032954
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INTRODUCTION: 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. METHODS AND ANALYSIS: 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.

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