流行性感冒疫苗保护效果真实世界研究专家共识

Expert consensus on methodology for real-world studies of influenza vaccine effectiveness

流行性感冒(流感)是由流感病毒引起的对人类健康危害较重的急性呼吸道传染病。接种流感疫苗是降低流感发病率、减轻其疾病负担的有效措施。在流感疫苗接种率较高的地区通过开展真实世界研究来评价其保护效果(vaccine effectiveness,VE)有助于免疫项目的优化和推广。因此,本共识对流感疫苗VE真实世界研究方法进行了系统梳理和分类总结,并对研究设计、数据分析的要点进行重点阐述,旨在为决策者、研究者、技术人员、疫苗有关生产供应商等提供系统、科学的流感疫苗VE真实世界研究技术指导。

Influenza virus substantially threatens human health by causing acute respiratory diseases.Influenza vaccination can effectively reduce influenza incidence and disease burden.In regions with relatively high influenza vaccine coverage,the enhancement and expansion of immunization programs can benefit from evidence from real-world studies(RWS)of influenza vaccine effectiveness(VE).To that end,the Chinese Preventive Medicine Association developed an expert consensus review and summary of research methods for RWS of influenza VE.The consensus elaborates critically important considerations of study design and data analysis,aiming to provide systematic and scientific guidance to decision-makers,researchers,technicians,and vaccine manufacturers on real-world studies of influenza vaccine effectiveness.