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

Antonio Carmona, Cintia Muñoz-Quiles, Anke Stuurman, Alexandre Descamps, Ainara Mira-Iglesias, Laurence Torcel-Pagnon and Javier Díez-Domingo
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Antonio Carmona: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (Fisabio), Avenida Cataluña 21, 46020 Valencia, Spain
Cintia Muñoz-Quiles: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (Fisabio), Avenida Cataluña 21, 46020 Valencia, Spain
Anke Stuurman: P-95 CVBA, Koning Leopold III laan 1, 3001 Heverlee, Belgium
Alexandre Descamps: INSERM CIC 1417, Assistance Publique-Hôpitaux de Paris, Université de Paris, Hôpital Cochin, 75005 Paris, France
Ainara Mira-Iglesias: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (Fisabio), Avenida Cataluña 21, 46020 Valencia, Spain
Laurence Torcel-Pagnon: Sanofi-Pasteur SA (SP), 14 Espace Henry Vallée, 69007 Lyon, France
Javier Díez-Domingo: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (Fisabio), Avenida Cataluña 21, 46020 Valencia, Spain

IJERPH, 2021, vol. 18, issue 3, 1-16

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.

Keywords: COVID-19; influenza; vaccination; vaccine effectiveness; test-negative design (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2021
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