通过欧洲药物署批准的疫苗所针对的群体
Débora D Gräf1, Lukas Westphal1, Jonathan Kimmelman2
1Department of Pharmacy, Copenhagen Centre for Regulatory Science, University of Copenhagen, Copenhagen, Denmark.
Clinical pharmacology and therapeutics
|May 6, 2025
概括
疫苗研究往往排除特殊人群. 对欧盟批准的疫苗的分析显示,在关键试验中仅限于孕妇,哺乳期或免疫受损患者,这影响了公平的疫苗开发.
科学领域:
- 疫苗学 疫苗学 疫苗学
- 监管科学 监管科学
- 临床试验 临床试验
背景情况:
- 强有力的证据对于治疗和预防药物至关重要.
- 随机对照试验 (RCT) 是安全性和疗效的关键,但往往排除特定人群.
- 疫苗开发和监管批准过程需要考虑各种患者群体.
研究的目的:
- 评估在欧盟范围内将特殊人群纳入疫苗注册研究和标签指示中的情况.
- 评估在疫苗的监管生命周期中对特殊人群的考虑.
- 发现疫苗开发中代表性不足的群体在证据生成方面的差距.
主要方法:
- 对产品标签,关键研究,风险管理计划和许可后研究的分析.
- 包括所有由欧洲药物署 (EMA) 在2012年至2022年期间中央批准的疫苗.
- 针对成年人,儿科,孕妇,哺乳期和免疫受损人群的疫苗指示的分类.
主要成果:
- 在31种批准的疫苗中,87%用于成人,68%用于儿科患者,但只有11%用于孕妇,14%用于母乳养,23%用于免疫受损人群.
- 孕妇,哺乳期和免疫受损的个体很少被纳入支持监管行动的研究中.
- 销售后的研究表明,特殊人群的纳入略有增加,但对产品标签或说明的影响有限.
结论:
- 监管机构和疫苗开发机构如何考虑不同人群存在显著差异.
- 支持注册疫苗的关键研究是高度选择性的,通常在高收入环境中进行.
- 增加特殊人群在证据生成中的参与对于公平的疫苗开发和解决未满足的医疗需求至关重要.
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