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疫苗的利益与风险的评估
Sonali Kochhar1, Hector S Izurieta2, Rebecca E Chandler3
1University of Washington, Seattle, USA; Global Healthcare Consulting, India.
Vaccine
|August 10, 2023
概括
利益风险评估 (BRA) 确保疫苗的好处超过风险. 一个新的模块为全球卫生决策制定这一关键评估提供了标准化.
科学领域:
- 疫苗学 疫苗学 疫苗学
- 公共卫生 公共卫生
- 监管科学 监管科学
背景情况:
- 利益风险评估 (BRA) 对于疫苗生命周期决策至关重要.
- 评估疫苗的好处是否超过风险需要科学证据和考虑不确定性.
- 进展包括结构化框架,定量模型和患者体验数据.
研究的目的:
- 为规划,评估和传达BRA信息提供结构化的利益风险评估模块.
- 为全球各个利益相关者促进可辩护的BRA.
- 支持监管提交和公共卫生对传染病和流行病的反应.
主要方法:
- 开发一个结构化的利益风险评估模块.
- 纳入科学证据评估,数据差距分析和不确定性评估.
- 使用灵敏度分析来解决不确定性.
主要成果:
- 一个全面的模块,使标准化BRA规划,评估和沟通.
- 在全球不同环境 (高,中,低收入国家) 中促进可辩护的BRA.
- 支持监管过程和公共卫生干预措施.
结论:
- 效益风险评估模块标准化并提高了疫苗效益风险评估的质量.
- 它支持全球疫苗开发商,监管机构和政策制定者的知情决策.
- 该模块适用于常规使用和传染病紧急响应.
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