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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.
Afiliación
  • Ciapponi A; Instituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Buenos Aires, Argentina.
  • Berrueta M; Instituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Buenos Aires, Argentina.
  • Ballivian J; Instituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Buenos Aires, Argentina.
  • Bardach A; Instituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Buenos Aires, Argentina.
  • Mazzoni A; Instituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Buenos Aires, Argentina.
  • Anderson S; US Food and Drug Administration, CBER, WA, Columbia.
  • Argento FJ; Instituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Buenos Aires, Argentina.
  • Bok K; National Institute of Allergy and Infectious Diseases (NIAID), Vaccine Research Center, Bethesda, MD.
  • Comandé D; Instituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Buenos Aires, Argentina.
  • Goucher E; School of Public Health and Tropical Medicine, Tulane University, New Orleans.
  • Kampmann B; The Vaccine Centre, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK.
  • Parker EPK; Vaccines & Immunity Theme, MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul, Gambia.
  • Rodriguez-Cairoli F; The Vaccine Centre, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK.
  • Santa Maria V; Instituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Buenos Aires, Argentina.
  • Stergachis A; Instituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Buenos Aires, Argentina.
  • Voss G; School of Pharmacy and School of Public Health, University of Washington, Seattle, WA.
  • Xiong X; Coalition for Epidemic Preparedness Innovations, Oslo, Norway.
  • Zaraa S; School of Public Health and Tropical Medicine, Tulane University, New Orleans.
  • Munoz FM; School of Pharmacy and School of Public Health, University of Washington, Seattle, WA.
  • Karron RA; Baylor College of Medicine, Texas Children's Hospital, Houston, TX.
  • Gottlieb SL; Center for Immunization Research, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD.
  • Buekens PM; Medical Officer, Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
Medicine (Baltimore) ; 102(9): e32954, 2023 Mar 03.
Article en En | MEDLINE | ID: mdl-36862871
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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Vacunas contra la COVID-19 / COVID-19 Tipo de estudio: Clinical_trials / Guideline / Observational_studies / Prevalence_studies / Prognostic_studies / Risk_factors_studies / Systematic_reviews Límite: Female / Humans / Newborn / Pregnancy Idioma: En Revista: Medicine (Baltimore) Año: 2023 Tipo del documento: Article País de afiliación: Argentina Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Vacunas contra la COVID-19 / COVID-19 Tipo de estudio: Clinical_trials / Guideline / Observational_studies / Prevalence_studies / Prognostic_studies / Risk_factors_studies / Systematic_reviews Límite: Female / Humans / Newborn / Pregnancy Idioma: En Revista: Medicine (Baltimore) Año: 2023 Tipo del documento: Article País de afiliación: Argentina Pais de publicación: Estados Unidos