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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...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier Inc.
2022
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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. |
format | Online Article Text |
id | pubmed-8824304 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Elsevier Inc. |
record_format | MEDLINE/PubMed |
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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