Challenges and Adaptation of a European Influenza Vaccine Effectiveness Study Platform in Response to the COVID-19 Emergence: Experience from the DRIVE Project

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.

Epidemiological and virological surveillance of Severe Acute Respiratory Infections in the 2019/2020 season in Siena, Tuscany, Italy

“…The COVID-19 outbreak impacted influenza surveillance; thus, the study period of the main analysis was truncated. Indeed, the pandemic and the subsequent lockdown measures curbed the already modest circulation of influenza and impacted data collection within DRIVE study sites [ 24 ]. Several DRIVE study sites implemented a different triage protocol in response to the SARS-CoV-2 emergency, whereby all SARI patients arriving at hospitals were first tested for SARS-CoV-2; if the results were negative, tests were performed for other respiratory viruses, such as influenza.…”

“…Several DRIVE study sites implemented a different triage protocol in response to the SARS-CoV-2 emergency, whereby all SARI patients arriving at hospitals were first tested for SARS-CoV-2; if the results were negative, tests were performed for other respiratory viruses, such as influenza. This new triage strategy was not expected to significantly reduce the number of influenza cases captured in the 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 [ 24 ]. Moreover, during the pandemic, the implementation of strict public health measures (e.g.…”

“…and operational procedures for the 2020/2021 season. Since then, DRIVE has closely tracked the evolution of the pandemic and has liaised with study sites in order to adapt rapidly to this ever-changing situation [ 24 ].…”

“…It was initiated as a response to the guidelines on influenza vaccines issued by the EMA (European Medicines Agency), which advised vaccine manufacturers to work with public health institutes to set up a joint IVE study platform [ 23 ]. The data generated through DRIVE are expected to increase the understanding of influenza vaccine effectiveness, lead to enhanced monitoring of influenza vaccine performance by public health institutes and allow manufacturers to fulfil regulatory requirements [ 24 ].…”

Surveillance of Severe Acute Respiratory Infection and Influenza Vaccine Effectiveness among Hospitalized Italian Adults, 2021/22 Season

“…This study was conducted between October 2021 and May 2022 and was part of the DRIVE (Development of Robust and Innovative Vaccine Effectiveness) project, which is a multi-country network aiming to assess the brand-specific SIV VE in Europe [ 14 ]. Objectives and methods of the DRIVE project are comprehensively described at (accessed on 14 November 2022).…”