The value of public-private collaborative real-world evidence platforms to monitor vaccine performance post authorization: DRIVE - a European initiative.
Por:
Díez-Domingo J, Torcel-Pagnon L, Carmona A, Launay O, Dos Santo G, Rizzo C, Haag M, Stuurman A, Nauta J, Vannacci A, de Lusignan S, Del Rey E, Levi M, Lina B, Bellino S, Nye S, Neels P, Nohynek H and Mahé C
Publicada:
1 dic 2022
Ahead of Print:
27 oct 2022
Resumen:
INTRODUCTION: Fighting pandemics requires an established infrastructure for pandemic preparedness, with existing, sustainable platforms ready to be activated. This includes platforms for disease surveillance, virus circulation, and vaccine performance monitoring based on Real-World data, to complement clinical trial evidence. AREAS COVERED: Because of its complexity, this can best be done by combining efforts between public and private sectors, developing a multi-stakeholder approach. Public-Private-Partnerships increasingly play a critical role in combating infectious diseases but are still looked at with hesitancy. The Development of Robust and Innovative Vaccine Effectiveness (DRIVE) project, which established a platform for measuring brand-specific influenza vaccine effectiveness in Europe, exemplifies how to build a collaborative platform with transparent governance, state-of-the-art methodology, and a large network of participating sites. Lessons learned from DRIVE have been cardinal to set up COVIDRIVE, a platform for brand-specific COVID-19 vaccine effectiveness monitoring. EXPERT OPINION: The DRIVE partners propose that a debate on the benefits of Public-Private-Partnership-generated real-world evidence for vaccine effectiveness monitoring should be pursued to clarify roles and responsibilities, set up expectations, and decide the future environment for vaccine monitoring in Europe. In parallel, the driving factors behind PPP hesitancy should be studied.
Filiaciones:
:
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (Fisabio), Avenida Cataluña 21, 46020 Valencia, Spain
Torcel-Pagnon L:
Modeling, Epidemiology and Data Science, Sanofi, 14 Espace Henry Vallée, 69007 Lyon, France
:
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (Fisabio), Avenida Cataluña 21, 46020 Valencia, Spain
Launay O:
Université Paris Descartes, Sorbonne Paris Cité, Inserm CIC 1417, Assistance Publique Hopitaux de Paris (APHP), CIC Cochin-Pasteur, rue du Faubourg St Jacques 27, 75679 Paris cedex 14, France
Dos Santo G:
GlaxoSmithKline, Wavre, Belgium
Rizzo C:
Functional Area of Clinical Pathways and Epidemiology, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy
Haag M:
Center of Outcomes Research and Epidemiology, Medical Affairs, Seqirus, Amsterdam, The Netherlands
Stuurman A:
P95 Epidemiology & Pharmacovigilance, Koning Leopold III laan 1, 3001 Heverlee, Belgium
Nauta J:
Abbott Healthcare Products B.V., C.J. van Houtenlaan 36, 1381 CP Weesp, The Netherlands
Vannacci A:
Department of Neurosciences, Psychology, Drug Research and Child Health, University of Florence, Firenze, Italy
de Lusignan S:
Department of Clinical and Experimental Medicine, University of Surrey, Guildford, United Kingdom
Del Rey E:
Synapse Research Management Partners SL (SYNAPSE), Calle Velazquez94, 1°, 28006, Madrid, Spain
Levi M:
Azienda USL Toscana Centro, Dipartimento di Prevenzione, Via di San Salvi, 12 - 50135 Firenze, Italy
Lina B:
University Claude Bernard Lyon, VirPath Research Laboratory, Lyon, France
Bellino S:
Istituto Superiore Di Sanita (ISS), Viale Regina Elena 299, ROMA 00161, Italy
Nye S:
Confederation Of Meningitis Organisations Ltd (CoMO), Newminster House Baldwin Street, Bristol BS1 1LT, United Kingdom
Neels P:
International Association for Biological Standardization for Europe, Lyon, France
Nohynek H:
Finnish Institute for Health and Welfare, Helsinki, Finland
Mahé C:
Modeling, Epidemiology and Data Science, Sanofi, 14 Espace Henry Vallée, 69007 Lyon, France
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