针对COVID-19疫苗接种的量化利益风险评估:系统性审查
E Claire Newbern1, Lea Wildisen2, Rita Verstraeten3
1Johnson & Johnson Innovative Medicine, Global Epidemiology, Horsham, Pennsylvania, USA.
Pharmacoepidemiology and drug safety
|January 31, 2025
概括
对37项COVID-19疫苗定量效益风险评估 (qBRA) 的审查发现,许多缺乏明确的方法和结果. 这凸显了未来疫苗评估需要更强大,更透明的qBRAs的需要.
科学领域:
- 药监和药物安全 药监和药物安全
- 疫苗的研发和研究.
- 卫生政策与经济 卫生政策与经济
背景情况:
- 量化利益风险评估 (qBRA) 对于评估疫苗的安全性和有效性至关重要.
- 之前的疫苗qBRA在报告方法和结果中显示出不一致.
- 由于COVID-19大流行,疫苗 qBRA 的出版物大幅增加.
研究的目的:
- 系统地识别和批判性地评估已发布的COVID-19疫苗qBRAs.
- 评估这些QBRA中的方法和结果的完整性和透明度.
- 为未来疫苗开发更强大,更可靠的qBRA提供信息.
主要方法:
- 针对COVID-19疫苗的系统文献审查 qBRAs 截至2023年4月17日.
- 包括来自文献数据库,卫生当局网站和灰色文献的数据.
- 对 qBRA 报告中通常预期的关键特征进行批判性评估.
主要成果:
- 从2220个出版物和18个其他来源识别了37个COVID-19疫苗qBRA.
- 评估包括mRNA和腺病毒载体疫苗;只有一个包括低收入和中等收入国家.
- 虽然25个报告使用了简单的计算,但15个报告使用了复杂的模型;然而,一些报告缺乏详细的数据来源和分析方法.
结论:
- 关键评估显示,COVID-19疫苗qBRAs的质量和透明度存在差异.
- 报告中发现的漏洞需要改进未来的疫苗益处风险评估.
- 这一审查为开发标准化,强大和透明的qBRAs提供了基础.
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