P95 Pharmacovigilance and Epidemiology, Leuven, Belgium.
FISABIO Public Health, Valencia, Spain.
Vaccine. 2020 Sep 22;38(41):6455-6463. doi: 10.1016/j.vaccine.2020.07.063. Epub 2020 Aug 7.
The DRIVE project aims to establish a sustainable network to estimate brand-specific influenza vaccine effectiveness (IVE) annually. DRIVE is a public-private partnership launched in response to EMA guidance that requires effectiveness evaluation from manufacturers for all individual influenza vaccine brands every season. IVE studies are conducted by public partners in DRIVE. Private partners (vaccine manufacturers from the European Federation of Pharmaceutical Industries and Association (EFPIA)) provide written feedback moderated by an independent scientific committee. Test-negative design (TND) case-control studies (4 in primary care and five in hospital) were conducted in six countries in Europe during the 2018/19 season. Site-specific confounder-adjusted vaccine effectiveness (VE) estimates for any vaccine exposure were calculated by age group (<18 years (y), 18-64y and 65 + y) and pooled by setting (primary care, hospital) through random effects meta-analysis. In addition, one population-based cohort study was conducted in Finland. TND studies included 3339 cases and 6012 controls; seven vaccine brands were reported. For ages 65 + y, pooled VE against any influenza strain was estimated at 27% (95%CI 6-44) in hospital setting. Sample size was insufficient for meaningful IVE estimates in other age groups, in the primary care setting, or by vaccine brand. The population-based cohort study included 274,077 vaccinated and 494,337 unvaccinated person-years, two vaccine brands were reported. Brand-specific IVE was estimated for Fluenz Tetra (36% [95%CI 24-45]) for ages 2-6y, Vaxigrip Tetra (54% [43-62]) for ages 6 months to 6y, and Vaxigrip Tetra (30% [25-35]) for ages 65 + y. The results presented are from the second influenza season covered by the DRIVE network. While sample size from the pooled TND studies was still too low for precise (brand-specific) IVE estimates, the network has approximately doubled in size compared to the pilot season. Taking measures to increase sample size is an important focus of DRIVE for the coming years.
DRIVE 项目旨在建立一个可持续的网络，每年估算特定品牌流感疫苗有效性（IVE）。DRIVE 是一个公私合作伙伴关系，是对欧洲药品管理局（EMA）指导意见的回应，该指导意见要求所有单个流感疫苗品牌每个季节都由制造商进行有效性评估。IVE 研究由 DRIVE 中的公共合作伙伴进行。私营合作伙伴（欧洲制药工业联合会和协会（EFPIA）的疫苗制造商）提供书面反馈，由独立科学委员会进行审核。在 2018/19 季节，欧洲六个国家进行了基于测试阴性设计（TND）的病例对照研究（初级保健中进行了 4 项研究，医院中进行了 5 项研究）。根据年龄组（<18 岁、18-64 岁和 65 岁以上）和环境（初级保健、医院）通过随机效应荟萃分析计算特定地点混杂因素调整后的疫苗有效性（VE）估计值。此外，在芬兰进行了一项基于人群的队列研究。TND 研究包括 3339 例病例和 6012 例对照；报告了七种疫苗品牌。对于 65 岁以上的人群，医院环境中针对任何流感株的汇总 VE 估计值为 27%（95%CI 6-44）。在其他年龄组、初级保健环境或疫苗品牌中，样本量不足，无法进行有意义的 IVE 估计。基于人群的队列研究包括 274077 例接种疫苗和 494337 例未接种疫苗的人年，报告了两种疫苗品牌。为年龄在 2-6 岁的 Fluenz Tetra（36%[95%CI 24-45]）、6 个月至 6 岁的 Vaxigrip Tetra（54%[43-62]）和 65 岁以上的 Vaxigrip Tetra（30%[25-35]）估计了特定品牌的 IVE。呈现的结果来自 DRIVE 网络涵盖的第二个流感季节。虽然来自汇总 TND 研究的样本量仍然太小，无法进行精确的（特定品牌）IVE 估计，但与试点季节相比，网络规模几乎翻了一番。增加样本量是 DRIVE 未来几年的一个重要重点。
