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COVID-19 vaccines: Considering sex differences in efficacy and safety

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 female...

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Autores principales: Jensen, Adelaide, Stromme, Masha, Moyassari, Shayda, Chadha, Antonella Santuccione, Tartaglia, Maria Carmela, Szoeke, Cassandra, Ferretti, Maria Teresa
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8824304/
https://www.ncbi.nlm.nih.gov/pubmed/35149232
http://dx.doi.org/10.1016/j.cct.2022.106700
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author Jensen, Adelaide
Stromme, Masha
Moyassari, Shayda
Chadha, Antonella Santuccione
Tartaglia, Maria Carmela
Szoeke, Cassandra
Ferretti, Maria Teresa
author_facet Jensen, Adelaide
Stromme, Masha
Moyassari, Shayda
Chadha, Antonella Santuccione
Tartaglia, Maria Carmela
Szoeke, Cassandra
Ferretti, Maria Teresa
author_sort Jensen, Adelaide
collection PubMed
description 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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spelling pubmed-88243042022-02-09 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 Contemp Clin Trials Review 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. Elsevier Inc. 2022-04 2022-02-08 /pmc/articles/PMC8824304/ /pubmed/35149232 http://dx.doi.org/10.1016/j.cct.2022.106700 Text en © 2022 Elsevier Inc. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Review
Jensen, Adelaide
Stromme, Masha
Moyassari, Shayda
Chadha, Antonella Santuccione
Tartaglia, Maria Carmela
Szoeke, Cassandra
Ferretti, Maria Teresa
COVID-19 vaccines: Considering sex differences in efficacy and safety
title COVID-19 vaccines: Considering sex differences in efficacy and safety
title_full COVID-19 vaccines: Considering sex differences in efficacy and safety
title_fullStr COVID-19 vaccines: Considering sex differences in efficacy and safety
title_full_unstemmed COVID-19 vaccines: Considering sex differences in efficacy and safety
title_short COVID-19 vaccines: Considering sex differences in efficacy and safety
title_sort covid-19 vaccines: considering sex differences in efficacy and safety
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8824304/
https://www.ncbi.nlm.nih.gov/pubmed/35149232
http://dx.doi.org/10.1016/j.cct.2022.106700
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