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COVID-19 vaccines: Considering sex differences in efficacy and safety.
Jensen, Adelaide; Stromme, Masha; Moyassari, Shayda; Chadha, Antonella Santuccione; Tartaglia, Maria Carmela; Szoeke, Cassandra; Ferretti, Maria Teresa.
Afiliación
  • Jensen A; School of Psychology, University of Ottawa, Canada; Women's Brain Project, Switzerland. Electronic address: ajens098@uottawa.ca.
  • Stromme M; 4HerHealth, Norway.
  • Moyassari S; Women's Brain Project, Switzerland.
  • Chadha AS; Women's Brain Project, Switzerland; Biogen International, Switzerland.
  • Tartaglia MC; Women's Brain Project, Switzerland; Tanz Centre for Research in Neurodegenerative Diseases, University of Toronto, Canada; Krembil Brain Institute, University Health Network, Canada.
  • Szoeke C; Women's Brain Project, Switzerland; Centre for Medical Research (RMH), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.
  • Ferretti MT; Women's Brain Project, Switzerland.
Contemp Clin Trials ; 115: 106700, 2022 04.
Article en En | MEDLINE | ID: mdl-35149232
ABSTRACT
The development of SARS-CoV-2 vaccines represents a significant breakthrough for managing the COVID-19 pandemic. However, their approval process has exposed a crucial limitation in clinical trial reports-that is, a disregard for sex differences in response to vaccines. Historically, males and females have shown different reactions to vaccines of many kinds, which have become apparent with the arrival of COVID-19 vaccines in late-2020. In this article, we review regulatory data from Phase III vaccine trials as well as peer-reviewed reports from vaccines administered to the general population, many of which failed to stratify results by sex. We also discuss the exclusion of pregnant and lactating persons in drug development and the regulatory guidelines for use of COVID-19 vaccines in such populations. We conclude by proposing some questions to stimulate discussion with the intent of advancing the field toward precision medicine.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Vacunas / COVID-19 Tipo de estudio: Clinical_trials / Guideline / Qualitative_research Límite: Female / Humans / Male / Pregnancy Idioma: En Revista: Contemp Clin Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2022 Tipo del documento: Article

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Vacunas / COVID-19 Tipo de estudio: Clinical_trials / Guideline / Qualitative_research Límite: Female / Humans / Male / Pregnancy Idioma: En Revista: Contemp Clin Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2022 Tipo del documento: Article