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

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
Año de publicación
2023
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
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.
Fil: Ciapponi, Agustín. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Berrueta, Mabel. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Ballivian, Jamile. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Bardach, Ariel Esteban. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina
Fil: Mazzoni, Agustina. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Anderson, Steven. Food And Drug Administration; Estados Unidos
Fil: Argento, Fernando J.. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Bok, Karin. National Institute of Allergy and Infectious Diseases; Estados Unidos
Fil: Comandé, Daniel. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Goucher, Erin. University of Tulane; Estados Unidos
Fil: Kampmann, Beate. London School of Hygiene and Tropical Medicine; Reino Unido
Fil: Parker, Edward P. K.. London School of Hygiene and Tropical Medicine; Reino Unido
Fil: Rodriguez Cairoli, Federico. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Santa María, Victoria. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Stergachis, Andy. University of Washington; Estados Unidos
Fil: Voss, Gerald. Coalition for Epidemic Preparedness Innovations; Noruega
Fil: Xiong, Xu. University of Tulane; Estados Unidos
Fil: Zaraa, Sabra. University of Washington; Estados Unidos
Fil: Munoz, Flor M.. Texas Children's Hospital Houston; Estados Unidos
Fil: Karron, Ruth A.. Johns Hopkins Bloomberg School Of Public Health; Estados Unidos
Fil: Gottlieb, Sami L.. Organizacion Mundial de la Salud; Argentina
Fil: Buekens, Pierre. University of Tulane; Estados Unidos
Materia
COVID-19
META-ANALYSIS
PREGNANCY
PROTOCOL
SYSTEMATIC REVIEW
VACCINE
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/229141
Acceder
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oai_identifier_str oai:ri.conicet.gov.ar:11336/229141
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Safety, immunogenicity, and effectiveness of COVID-19 vaccines for pregnant persons: A protocol for systematic review and meta analysisCiapponi, AgustínBerrueta, MabelBallivian, JamileBardach, Ariel EstebanMazzoni, AgustinaAnderson, StevenArgento, Fernando J.Bok, KarinComandé, DanielGoucher, ErinKampmann, BeateParker, Edward P. K.Rodriguez Cairoli, FedericoSanta María, VictoriaStergachis, AndyVoss, GeraldXiong, XuZaraa, SabraMunoz, Flor M.Karron, Ruth A.Gottlieb, Sami L.Buekens, PierreCOVID-19META-ANALYSISPREGNANCYPROTOCOLSYSTEMATIC REVIEWVACCINEhttps://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3Introduction: 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.Fil: Ciapponi, Agustín. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Berrueta, Mabel. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Ballivian, Jamile. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Bardach, Ariel Esteban. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: Mazzoni, Agustina. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Anderson, Steven. Food And Drug Administration; Estados UnidosFil: Argento, Fernando J.. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Bok, Karin. National Institute of Allergy and Infectious Diseases; Estados UnidosFil: Comandé, Daniel. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Goucher, Erin. University of Tulane; Estados UnidosFil: Kampmann, Beate. London School of Hygiene and Tropical Medicine; Reino UnidoFil: Parker, Edward P. K.. London School of Hygiene and Tropical Medicine; Reino UnidoFil: Rodriguez Cairoli, Federico. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Santa María, Victoria. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Stergachis, Andy. University of Washington; Estados UnidosFil: Voss, Gerald. Coalition for Epidemic Preparedness Innovations; NoruegaFil: Xiong, Xu. University of Tulane; Estados UnidosFil: Zaraa, Sabra. University of Washington; Estados UnidosFil: Munoz, Flor M.. Texas Children's Hospital Houston; Estados UnidosFil: Karron, Ruth A.. Johns Hopkins Bloomberg School Of Public Health; Estados UnidosFil: Gottlieb, Sami L.. Organizacion Mundial de la Salud; ArgentinaFil: Buekens, Pierre. University of Tulane; Estados UnidosLippincott Williams2023-03info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/229141Ciapponi, Agustín; Berrueta, Mabel; Ballivian, Jamile; Bardach, Ariel Esteban; Mazzoni, Agustina; et al.; Safety, immunogenicity, and effectiveness of COVID-19 vaccines for pregnant persons: A protocol for systematic review and meta analysis; Lippincott Williams; Medicine; 102; 9; 3-2023; 1-50025-7974CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/doi/10.1097/MD.0000000000032954info:eu-repo/semantics/altIdentifier/url/https://journals.lww.com/md-journal/fulltext/2023/03030/safety,_immunogenicity,_and_effectiveness_of.20.aspxinfo:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-03T09:53:32Zoai:ri.conicet.gov.ar:11336/229141instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-03 09:53:33.134CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv 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
spellingShingle Safety, immunogenicity, and effectiveness of COVID-19 vaccines for pregnant persons: A protocol for systematic review and meta analysis
Ciapponi, Agustín
COVID-19
META-ANALYSIS
PREGNANCY
PROTOCOL
SYSTEMATIC REVIEW
VACCINE
title_short 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_sort Safety, immunogenicity, and effectiveness of COVID-19 vaccines for pregnant persons: A protocol for systematic review and meta analysis
dc.creator.none.fl_str_mv 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
author Ciapponi, Agustín
author_facet 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
author_role author
author2 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
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv COVID-19
META-ANALYSIS
PREGNANCY
PROTOCOL
SYSTEMATIC REVIEW
VACCINE
topic COVID-19
META-ANALYSIS
PREGNANCY
PROTOCOL
SYSTEMATIC REVIEW
VACCINE
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.3
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv 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.
Fil: Ciapponi, Agustín. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Berrueta, Mabel. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Ballivian, Jamile. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Bardach, Ariel Esteban. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina
Fil: Mazzoni, Agustina. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Anderson, Steven. Food And Drug Administration; Estados Unidos
Fil: Argento, Fernando J.. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Bok, Karin. National Institute of Allergy and Infectious Diseases; Estados Unidos
Fil: Comandé, Daniel. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Goucher, Erin. University of Tulane; Estados Unidos
Fil: Kampmann, Beate. London School of Hygiene and Tropical Medicine; Reino Unido
Fil: Parker, Edward P. K.. London School of Hygiene and Tropical Medicine; Reino Unido
Fil: Rodriguez Cairoli, Federico. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Santa María, Victoria. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Stergachis, Andy. University of Washington; Estados Unidos
Fil: Voss, Gerald. Coalition for Epidemic Preparedness Innovations; Noruega
Fil: Xiong, Xu. University of Tulane; Estados Unidos
Fil: Zaraa, Sabra. University of Washington; Estados Unidos
Fil: Munoz, Flor M.. Texas Children's Hospital Houston; Estados Unidos
Fil: Karron, Ruth A.. Johns Hopkins Bloomberg School Of Public Health; Estados Unidos
Fil: Gottlieb, Sami L.. Organizacion Mundial de la Salud; Argentina
Fil: Buekens, Pierre. University of Tulane; Estados Unidos
description 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.
publishDate 2023
dc.date.none.fl_str_mv 2023-03
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/229141
Ciapponi, Agustín; Berrueta, Mabel; Ballivian, Jamile; Bardach, Ariel Esteban; Mazzoni, Agustina; et al.; Safety, immunogenicity, and effectiveness of COVID-19 vaccines for pregnant persons: A protocol for systematic review and meta analysis; Lippincott Williams; Medicine; 102; 9; 3-2023; 1-5
0025-7974
CONICET Digital
CONICET
url http://hdl.handle.net/11336/229141
identifier_str_mv Ciapponi, Agustín; Berrueta, Mabel; Ballivian, Jamile; Bardach, Ariel Esteban; Mazzoni, Agustina; et al.; Safety, immunogenicity, and effectiveness of COVID-19 vaccines for pregnant persons: A protocol for systematic review and meta analysis; Lippincott Williams; Medicine; 102; 9; 3-2023; 1-5
0025-7974
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/doi/10.1097/MD.0000000000032954
info:eu-repo/semantics/altIdentifier/url/https://journals.lww.com/md-journal/fulltext/2023/03030/safety,_immunogenicity,_and_effectiveness_of.20.aspx
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
application/pdf
dc.publisher.none.fl_str_mv Lippincott Williams
publisher.none.fl_str_mv Lippincott Williams
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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