Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Dutch Medicines Evaluation Board, Utrecht, The Netherlands.
BMJ Glob Health. 2022 Mar;7(3). doi: 10.1136/bmjgh-2021-008173.
An under-representation of women and a lack of sex-specific analyses in COVID-19 trials has been suggested. However, the higher number of men than women who are severely affected by COVID-19 and the restricted information in scientific publications may have biased these suggestions. Therefore, we evaluated sex proportionality and sex-specific efficacy and safety data in trials of COVID-19 treatments and vaccines using both publicly available regulatory documents and confidential documents used by regulators in their review of medicinal products. Included were two treatments (ie, remdesivir and dexamethasone) and four vaccines (ie, BNT162b2 mRNA (BioNTech/Pfizer), mRNA-1273 (Moderna), ChAdOx1-S (AstraZeneca) and Ad26.COV2-S (Janssen)) that received marketing authorisation by the European Commission at the time of the study conduct. An under-representation of women was shown in three of the nine data sets for one treatment (ie, remdesivir), but the proportion of women included was representative in each of the data sets for the other five products. This indicates that there is no structural under-representation of women in the COVID-19 trials. Currently, sex-specific efficacy data are available for five of the six assessed products and sex-specific safety data are available for half of the products only. It is important that this information will also be made available for the other products. There are only small differences in efficacy and safety between men and women which are likely to be of limited clinical relevance. Sex-specific efficacy information can generally be found in the publicly available regulatory documents other than the Summary of Product Characteristics, for which more awareness might be required.
有研究表明，在 COVID-19 试验中，女性代表性不足，且缺乏针对女性的分析。然而，受 COVID-19 严重影响的男性人数多于女性，且科学出版物中的信息有限，这可能会对这些研究结果产生偏见。因此，我们使用公共监管文件和监管机构在评估药品时使用的机密文件，评估了 COVID-19 治疗和疫苗试验中的性别比例以及针对女性的疗效和安全性数据。研究中包含了两种治疗方法（即瑞德西韦和地塞米松）和四种疫苗（即 BNT162b2 mRNA（辉瑞/BioNTech）、mRNA-1273（莫德纳）、ChAdOx1-S（阿斯利康）和 Ad26.COV2-S（杨森）），这些产品在研究期间均获得了欧盟委员会的上市许可。在九组数据中有三组数据显示一种治疗方法（即瑞德西韦）中女性代表性不足，但其他五种产品的每一组数据中纳入的女性比例都具有代表性。这表明 COVID-19 试验中不存在女性结构性代表性不足的情况。目前，六种评估产品中有五种提供了针对女性的疗效数据，只有一半的产品提供了针对女性的安全性数据。重要的是，其他产品也应提供这些信息。男性和女性在疗效和安全性方面只有很小的差异，这可能具有有限的临床意义。除了药品特性摘要外，一般可以在公共监管文件中找到针对女性的疗效信息，对此可能需要提高认识。
