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

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.

MEDICINE

LIPPINCOTT WILLIAMS & WILKINS

Año: 2023 vol. 102

0025-7974

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.