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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., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Anke L. Stuurman, Kaatje Bollaerts, Maria Alexandridou, Jorne Biccler, Tom De Smedt, Nick De Smedt and Margarita Riera-Montes declare that P95 Epidemiology and Pharmacovigilance has held contracts for research work with GSK and Seqirus. Javier Díez-Domingo declares to have received honoraria from Sanofi Pasteur for advisory boards. Hanna Nohynek declares that her institution holds / has held a research contract with influenza vaccine manufactures GSK and Sanofi Pasteur on both non-influenza and influenza related research but she is not a recipient of these funds. Caterina Rizzo declares to have received an unconditional funding from Seqirus for a cost-effectiveness analysis in 2019. Topi Turunen declares to be the local subinvestigator in the FinFluHD study funded by the Finnish Institute for Health and Welfare and Sanofi Pasteur. Anca Cristina Dragonescu declares that she is the principal investigator for the GIHSN project funded by Foundation for Influenza Epidemiology financed by Sanofi Pasteur. Anuta Bilasco, Ovidiu Vlaicu and Dan Otelea have no conflict of interest to declare. Adrian Streinu-Cercel declares that he is a member of the research team of the GIHSN project funded by Foundation for Influenza Epidemiology financed by Sanofi Pasteur, and a subinvestigator in influenza clinical trials by Shionogi and F. Hoffmann-La Roche. Anca Streinu-Cercel declares that she is principal investigator for the I-MOVE + study funded through the European Union’s HORIZON 2020 research and innovation programme, and a subinvestigator in influenza clinical trials by Shionogi and F. Hoffmann-La Roche. Oana Sandulescu declares that she is a member of the research team of the GIHSN project funded by Foundation for Influenza Epidemiology financed by Sanofi Pasteur, and a subinvestigator in influenza clinical trials by Shionogi and F. Hoffmann-La Roche. Victoria Arama declares that she is a member of the research team of the GIHSN project funded by Foundation for Influenza Epidemiology financed by Sanofi Pasteur, and a member of the research team for the I-MOVE + study funded through the European Union’s HORIZON 2020 research and innovation programme. Daniela Pitigoi declares that she is principal investigator for the I-MOVE + study funded through the European Union’s HORIZON 2020 research and innovation programme, and a technical project manager for the GIHSN project funded by Foundation for Influenza Epidemiology financed by Sanofi Pasteur. Dragos Florea declares that he is a member of the research team of the GIHSN project funded by Foundation for Influenza Epidemiology financed by Sanofi Pasteur. Monica Luminita-Luminos declares that she is a member of the research team of the GIHSN project funded by Foundation for Influenza Epidemiology financed by Sanofi Pasteur. José Ángel Rodrigo-Pendás declares that he is a collaborator in two studies funded by GSK (Enhanced safety surveillance of GSK's quadrivalent seasonal influenza vaccines. EPI-FLU-056 VS EUR (2018–2019) & EPI-FLU- 056 VS EUR (2019–2020) and Safety and immunogenicity study of GSK Biologicals’ Herpes Zoster subunit vaccine (HZ/su) GSK1437173A on a two-dose schedule in adults ≥ 50 years of age with a prior episode of Herpes Zoster (ZOSTER-062 (204939)). EudraCT number: 2016–000744-34) and a collaborator in a clinical trial funded by a government grant (Phase IV, open, low-level intervention, clinical trial to compare the immunogenicity in immunosuppressed patients of an adjuvanted anti-hepatitis B vaccine with an anti-hepatitis B vaccine with increased antigenic load (HEPB-VAC-01). EudraCT number: 2018–002368-18). Paolo Bonanni declares that he has taken part as a co-author in different HTA evaluations of influenza vaccines in the Italian context for the elderly (co-financed by Seqirus) and for children (co-financed by Sanofi Pasteur) with no personal fees received. He has also taken part in advisory boards and formative events for Seqirus and Sanofi Pasteur with occasional payment of expenses and fees. Ritva K. Syrjänen declares that she is a co-investigator in pneumococcal studies for which her employer (Finnish Institute for Health and Welfare) has received research support from GSK; co-investigator in a clinical trial of influenza vaccines in the elderly funded by Sanofi Pasteur (not related to this study); and collaborator for the I-MOVE + study funded through the European Union’s HORIZON 2020 research and innovation programme. Ulrike Baum declares that her employer (Finnish Institute for Health and Welfare) has been contracted for a clinical trial of influenza vaccines in the elderly funded by Sanofi Pasteur. Anuta Bilasco, Ovidiu Vlaicu, Ainara Mira-Iglesias, Alfredo Vannacci, Claudia Ravaldi, Eva del Amo Morán, Miriam Levi, Monika Redlberger-Fritz, Roberto Bonaiuti, Cristina Andrés, Maria Chironna, Harshana Liyanage, Uy Hoang, Ornella Punzo, Stefania Bellino, Kirsi Skogberg, Simon de Lusignan, Andrés Antón, Antonino Bella, Raija Auvinen, Sonia Uriona Tuma, Ilaria Manini, Niina Ikonen, Raisa Loginov, Christian Napoli, F. Xavier López-Labrador, Giancarlo Icardi, Donatella Panatto, Piero Luigi Lai, Andrea Orsi, Stefano Mosca and Dan Otelea have no conflict of interest to declare., (Copyright © 2020. Published by Elsevier Ltd.)

A safety signal around Pandemrix, an AS03 adjuvanted influenza A(H1N1) pdm09 vaccine potentially causing narcolepsy in children and adolescents became public in August 2010, long after cessation of the influenza A(H1N1) pdm09 campaigns in Europe. The signal originated from Finland and Sweden, two countries with school based pandemic vaccination campaigns, with high vaccine coverage, and vaccinations being provided at the peak of the circulating wild virus. Since the announcement awareness grew in Europe, with extensive public media dissemination and regulatory actions. This resulted in a steep increase in the spontaneous reports of exposed cases, a decrease in diagnostic lag times of this rare, underdiagnosed disease and finally victim compensation. The signaling countries conducted rapid risk assessment studies to quantify the signal to the best of their abilities, in the midst of the public awareness, most of which could not distinguish between a vaccine and an awareness effect. Due to the strong but variable associations from the epidemiological studies, the search for biological mechanisms started. Currently it is not yet understood how Pandemrix might cause narcolepsy, and whether it would be specific to Pandemrix. The paper describes the current evidence and puts forward the questions that remain to be answered, which are relevant for future pandemic preparedness when adjuvants may be used for dose sparing., (Copyright © 2015. Published by Elsevier Ltd.)