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Safety, immunogenicity, and effectiveness of COVID-19 vaccines for pregnant persons: A protocol for systematic review and meta analysis
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 availa...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Lippincott Williams & Wilkins
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9981247/ https://www.ncbi.nlm.nih.gov/pubmed/36862871 http://dx.doi.org/10.1097/MD.0000000000032954 |
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author | 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. |
author_facet | 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. |
author_sort | Ciapponi, Agustín |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-9981247 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-99812472023-03-03 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 (Baltimore) 5600 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. Lippincott Williams & Wilkins 2023-03-03 /pmc/articles/PMC9981247/ /pubmed/36862871 http://dx.doi.org/10.1097/MD.0000000000032954 Text en Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY) (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | 5600 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. Safety, immunogenicity, and effectiveness of COVID-19 vaccines for pregnant persons: A protocol for systematic review and meta analysis |
title | Safety, immunogenicity, and effectiveness of COVID-19 vaccines for pregnant persons: A protocol for systematic review and meta analysis |
title_full | Safety, immunogenicity, and effectiveness of COVID-19 vaccines for pregnant persons: A protocol for systematic review and meta analysis |
title_fullStr | Safety, immunogenicity, and effectiveness of COVID-19 vaccines for pregnant persons: A protocol for systematic review and meta analysis |
title_full_unstemmed | Safety, immunogenicity, and effectiveness of COVID-19 vaccines for pregnant persons: A protocol for systematic review and meta analysis |
title_short | Safety, immunogenicity, and effectiveness of COVID-19 vaccines for pregnant persons: A protocol for systematic review and meta analysis |
title_sort | safety, immunogenicity, and effectiveness of covid-19 vaccines for pregnant persons: a protocol for systematic review and meta analysis |
topic | 5600 |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9981247/ https://www.ncbi.nlm.nih.gov/pubmed/36862871 http://dx.doi.org/10.1097/MD.0000000000032954 |
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