Abstract
The Development of Robust and Innovative Vaccine Effectiveness (DRIVE) project is a public–private partnership aiming to build capacity in Europe for yearly estimation of brand-specific influenza vaccine effectiveness (IVE). DRIVE is a five-year project funded by IMI (Innovative Medicines Initiative). It was initiated as a response to the guidance on influenza vaccines by EMA (European Medicines Agency), which advised vaccine manufacturers to work with public health institutes to set up a joint IVE study platform. The COVID-19 pandemic reached Europe in February 2020 and overlapped with the 2019/2020 influenza season only in the last weeks. However, several elements of the DRIVE study network were impacted. The pandemic specifically affected the study sites’ routines and the subsequent assessment of the 2019/20 influenza season. Moreover, the current social distancing measures and lockdown policies across Europe are expected to also limit the circulation of influenza for the 2020/21 season, and therefore the impact of COVID-19 will be higher than in the season 2019/20. Consequently, DRIVE has planned to adapt its study platform to the COVID-19 challenge, encompassing several COVID-19 particularities in the study procedures, data collection and IVE analysis for the 2020/21 season. DRIVE will study the feasibility of implementing these COVID-19 components and establish the foundations of future COVID-19 vaccine effectiveness studies.
Highlights
//www.drive-eu.org/) project was launched as a five-year public–private partnership in order to respond to a guideline issued in 2017 by the European Medicines Agency (EMA), requesting vaccine manufacturers to provide a yearly brand-specific effectiveness evaluation for all influenza vaccines as part of their post-licensure regulatory requirements [1]
This new triage strategy was not expected to significantly reduce the number of influenza cases captured in the Development of Robust and Innovative Vaccine Effectiveness (DRIVE) dataset in 2019/2020, as very few cases of co-infection of influenza/SARS-CoV-2 were reported at the DRIVE sites that did test swabs for both viruses; this was due the minimal overlap between the influenza season and the emergence of the SARS-CoV-2 pandemic
DRIVE was able to obtain precise brand-specific influenza vaccine effectiveness (IVE) estimates in the 2019/2020 season despite the start of the COVID-19 pandemic during the influenza season [2]. This achievement reflects the soundness of the DRIVE study network and how well DRIVE study sites managed the challenges posed by the COVID-19 pandemic, which have been reflected in the present paper
Summary
//www.drive-eu.org/) project was launched as a five-year public–private partnership in order to respond to a guideline issued in 2017 by the European Medicines Agency (EMA), requesting vaccine manufacturers to provide a yearly brand-specific effectiveness evaluation for all influenza vaccines as part of their post-licensure regulatory requirements [1]. For this purpose, the European Commission, through the Innovative Medicines Initiative (IMI), supported the DRIVE project, a pioneer public–private partnership (PPP) that advances European cooperation in influenza vaccine effectiveness (IVE) studies.
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