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

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 rare...

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Detalhes bibliográficos
Autores: Ciapponi, Agustín, Berrueta, Mabel, Ballivian, Jamile, Bardach, Ariel Esteban, Mazzoni, Agustina, Anderson, Steven, Argento, Fernando J., Bok, Karin, Comandé, Daniel, Goucher, Erin, Kampmann, Beate, Parker, Edward P. K., Rodriguez Cairoli, Federico, Santa María, Victoria, Stergachis, Andy, Voss, Gerald, Xiong, Xu, Zaraa, Sabra, Munoz, Flor M., Karron, Ruth A., Gottlieb, Sami L., Buekens, Pierre
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2023
País:Argentina
Recursos:Consejo Nacional de Investigaciones Científicas y Técnicas
Repositorio:CONICET Digital (CONICET)
Idioma:inglés
OAI Identifier:oai:ri.conicet.gov.ar:11336/229141
Acesso em linha:http://hdl.handle.net/11336/229141
Access Level:acceso abierto
Palavra-chave:COVID-19
META-ANALYSIS
PREGNANCY
PROTOCOL
SYSTEMATIC REVIEW
VACCINE
https://purl.org/becyt/ford/3.3
https://purl.org/becyt/ford/3
Descrição
Resumo: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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