Jensen Adelaide, Stromme Masha, Moyassari Shayda, Chadha Antonella Santuccione, Tartaglia Maria Carmela, Szoeke Cassandra, Ferretti Maria Teresa
School of Psychology, University of Ottawa, Canada; Women's Brain Project, Switzerland.
4HerHealth, Norway.
Contemp Clin Trials. 2022 Apr;115:106700. doi: 10.1016/j.cct.2022.106700. Epub 2022 Feb 8.
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.
严重急性呼吸综合征冠状病毒2（SARS-CoV-2）疫苗的研发是应对2019冠状病毒病（COVID-19）大流行的一项重大突破。然而，其审批过程暴露了临床试验报告中的一个关键局限，即忽视了疫苗反应中的性别差异。从历史上看，男性和女性对多种疫苗表现出不同反应，随着2020年末COVID-19疫苗的问世，这种差异变得明显起来。在本文中，我们回顾了III期疫苗试验的监管数据以及针对普通人群接种疫苗的同行评审报告，其中许多报告未能按性别对结果进行分层。我们还讨论了药物研发中对孕妇和哺乳期妇女的排除以及此类人群使用COVID-19疫苗的监管指南。我们通过提出一些问题来促进讨论，以期推动该领域向精准医学发展。
