To examine the contribution that field efficacy studies made to the assessment of marketing authorisation (MA) applications, a retrospective analysis was conducted for 100 veterinary vaccines that had been evaluated by the European Medicines Agency (EMA) between 1996 and 2017. For 52 veterinary vaccines, scrutiny of the European Public Assessment Report (EPAR) and/or the summary of product characteristics (SPC) identified objective evidence that field efficacy studies made an important or substantial impact on the efficacy claims and/or benefit-risk evaluation. For 24 applications, the contribution of field efficacy studies was classified as either supportive or was not detectable from the publicly available documents on which the analysis was based. For a further 24 applications, data exemptions were applied and the MAs were granted in the absence of field studies. The difficulty in achieving challenge in the field was highlighted by the observation that natural exposure was reported in less than half of the applications where field efficacy studies were conducted (34 out of 76). This analysis may help to inform policy decisions on the role, conduct and contribution that field efficacy studies make to the assessment of efficacy for veterinary vaccines.

为了检查现场功效研究对评估上市许可 (MA) 申请的贡献，对 1996 年至 2017 年间由欧洲药品管理局 (EMA) 评估的 100 种兽用疫苗进行了回顾性分析。 对于 52 种兽用疫苗、欧洲公共评估报告 (EPAR) 和/或产品特性摘要 (SPC) 的审查确定了客观证据，表明现场功效研究对功效声明和/或利益风险评估产生了重要或实质性的影响。对于 24 项申请，田间功效研究的贡献被归类为支持性或无法从分析所依据的公开可用文件中检测到。对于另外 24 个应用程序，在没有实地研究的情况下，应用了数据豁免，并授予了 MA。在进行田间功效研究的应用中，只有不到一半的应用报告了自然暴露（76 项中的 34 项），这一观察结果凸显了在该领域实现挑战的难度。这种分析可能有助于为关于实地功效研究对兽用疫苗功效评估的作用、实施和贡献的政策决策提供信息。