The value of public-private collaborative real-world evidence platforms to monitor vaccine performance post authorization: DRIVE - a European initiative

Díez-Domingo, Javier; Torcel-Pagnon, Laurence; Carmona, Antonio Losa; Launay, Odile; Santos, Gaël Dos; Rizzo, Caterina; Haag, Mendel; Stuurman, Anke L.; Nauta, J. J. P.; Vannacci, Alfredo; Lusignan, Simon de; Rey, Elena Del; Levi, Miriam; Lina, Bruno; Bellino, Stefania; Nye, Samantha; Neels, Pieter; Nohynek, Hanna; Mahé, Cédric

doi:10.1080/14760584.2022.2137144

Cited by 5 publications

(5 citation statements)

References 20 publications

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“…Over the past decades, a shift in the traditional model of medicine development has become discernible. Academia‐driven initiatives and PPPs are emerging in various medicine development stages with a relatively small number actually realizing the authorization of medicinal products for IEMs 23,39,58,85 . Recent examples that did not lead to sustainable and equal access for all, such as the Glybera case, highlight the need to include socially responsible terms for patient access in collaborations 23,29,39,41,42 .…”

Section: Discussionmentioning

confidence: 99%

“…More recent stakeholders in PPPs include patient organizations, regulatory agencies, health technology assessment bodies, health insurance companies, IT‐companies, and European Reference Networks 56 . Governance structures that balance perspectives of all stakeholders should include scientific and auditing committees, financial administrators, and management or coordinators 57,58 . Such structures can support the mitigation of conflicts of interest 59 …”

Section: Methodsmentioning

confidence: 99%

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Development of medicines for rare diseases and inborn errors of metabolism: Toward novel public–private partnerships

Rosenberg

Stolwijk

Berg

et al. 2023

J of Inher Metab Disea

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Medicine development for rare diseases, including inborn errors of metabolism (IEMs) is challenging. Many academic innovations fail to reach the patient, either by stranding in the translational stage or due to suboptimal patient access related to pricing or uncertain effectiveness. Expanding and solidifying the role of the academic in public–private partnerships (PPPs) may present an innovative solution to help overcome these complexities. This narrative review explores the literature on traditional and novel collaborative approaches to medicine development for rare diseases and analyzes examples of PPPs, with a specific focus on IEMs. Several academic institutions have introduced guidelines for socially responsible licensing of innovations for private development. The PPP model offers a more integrative approach toward academic involvement of medicine development. By sharing risks and rewards, failures in the translational stage can be mutually absorbed. If socially responsible terms are not included, however, high pricing can impede patient access. Therefore, we propose a framework for socially responsible PPPs aimed at medicine development for metabolic disorders. This socially responsible PPP framework could stimulate successful and accessible medicine development for IEMs as well as other rare diseases if the establishment of such collaborations includes terms securing joint data ownership and evidence generation, fast access, and socially responsible pricing.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Development of medicines for rare diseases and inborn errors of metabolism: Toward novel public–private partnerships

Rosenberg

Stolwijk

Berg

et al. 2023

J of Inher Metab Disea

View full text Add to dashboard Cite

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“…The Development of Robust and Innovative Vaccine Effectiveness (DRIVE) project is a public–private partnership that was conceived in 2017 as a proof of concept for the annual estimation of brand-specific IVE in Europe ( 2 ). DRIVE was a 5-year Innovative Medicines Initiative (IMI) project, equally funded by the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA).…”

Section: Introductionmentioning

confidence: 99%

“…For the dual goal of addressing regulatory requirements and generating brand-specific IVE data for public health purposes, a multi-stakeholder public–private partnership of 16 partners from public health institutes, academia, small and medium-sized enterprises, and vaccine companies was established ( 2 ). The consortium managed to create a unique, large, and efficient study platform ( Figure 1 ), as a large and geographically diverse network is required to obtain a sufficient sample size and to cover all vaccine brands in Europe.…”

Section: Introductionmentioning

confidence: 99%

Brand-specific estimates of influenza vaccine effectiveness for the 2021–2022 season in Europe: results from the DRIVE multi-stakeholder study platform

Stuurman¹,

Carmona

Biccler³

et al. 2023

Front. Public Health

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IntroductionDevelopment of Robust and Innovative Vaccine Effectiveness (DRIVE) was a European public–private partnership (PPP) that aimed to provide annual, brand-specific estimates of influenza vaccine effectiveness (IVE) for regulatory and public health purposes. DRIVE was launched in 2017 under the umbrella of the Innovative Medicines Initiative (IMI) and conducted IVE studies from its pilot season in 2017–2018 to its final season in 2021–2022.MethodsIn 2021–2022, DRIVE conducted four primary care-based test-negative design (TND) studies (Austria, Italy, Iceland, and England; involving >1,000 general practitioners), nine hospital-based TND studies (France, Iceland, Italy, Romania, and Spain, for a total of 21 hospitals), and one population-based cohort study in Finland. In the TND studies, patients with influenza-like illness (primary care) or severe acute respiratory infection (hospital) were enrolled, and laboratory tested for influenza using RT-PCR. Study contributor-specific IVE was calculated using logistic regression, adjusting for age, sex, and calendar time, and pooled by meta-analysis.ResultsIn 2021–2022, pooled confounder-adjusted influenza vaccine effectiveness (IVE) estimates against laboratory-confirmed influenza (LCI) overall and per type and subtype/lineage was produced, albeit with wide confidence intervals (CI). The limited circulation of influenza in Europe did not allow the network to reach the optimal sample size to produce precise IVE estimates for all the brands included. The most significant IVE estimates were 76% (95% CI 23%−93%) for any vaccine and 81% (22%−95%) for Vaxigrip Tetra in adults ≥65 years old and 64% (25%−83%) for Fluenz Tetra in children (TND primary care setting), 85% (12%−97%) for any vaccine in adults 18–64 years (TND hospital setting), and 38% (1%−62%) in children 6 months−6 years (population-based cohort, mixed setting).DiscussionOver five seasons, DRIVE collected data on >35,000 patients, more than 60 variables, and 13 influenza vaccines. DRIVE demonstrated that estimating brand-specific IVE across Europe is possible, but achieving sufficient sample size to obtain precise estimates for all relevant stratifications remains a challenge. Finally, DRIVE's network of study contributors and lessons learned have greatly contributed to the development of the COVID-19 vaccine effectiveness platform COVIDRIVE.

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“…This paper describes a systematic review and meta-analysis of RCTs and TNDs conducted to assess the VER and VE of SIVs in humans aged 15 to 64 years. Despite several papers describing performed reviews of the VER of the SIV or its effectiveness are available [ 22 , 23 , 24 , 25 , 26 , 27 ], information regarding VE is scarce. In this sense, the main objective of this work is to measure the effect of a vaccine assessed in RCTs and TNDs using a common measure: VE.…”

Section: Introductionmentioning

confidence: 99%

Seasonal Influenza Vaccine Effectiveness in Persons Aged 15–64 Years: A Systematic Review and Meta-Analysis

et al. 2023

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Influenza is a respiratory disease caused by the influenza virus, which is highly transmissible in humans. This paper presents a systematic review and meta-analysis of randomized controlled trials (RCTs) and test-negative designs (TNDs) to assess the vaccine effectiveness (VE) of seasonal influenza vaccines (SIVs) in humans aged 15 to 64 years. An electronic search to identify all relevant studies was performed. The outcome measure of interest was VE on laboratory-confirmed influenza (any strain). Quality assessment was performed using the Cochrane risk-of-bias tool for RCTs and the ROBINS-I tool for TNDs. The search identified a total of 2993 records, but only 123 studies from 73 papers were included in the meta-analysis. Of these studies, 9 were RCTs and 116 were TNDs. The pooled VE was 48% (95% CI: 42–54) for RCTs, 55.4% (95% CI: 43.2–64.9) when there was a match between the vaccine and most prevalent circulating strains and 39.3% (95% CI: 23.5–51.9) otherwise. The TNDs’ adjusted VE was equal to 39.9% (95% CI: 31–48), 45.1 (95% CI: 38.7–50.8) when there was a match and 35.1 (95% CI: 29.0–40.7) otherwise. The match between strains included in the vaccine and strains in circulation is the most important factor in the VE. It increases by more than 25% when there is a match with the most prevalent circulating strains. The laboratorial method for confirmation of influenza is a possible source of bias when estimating VE.

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The value of public-private collaborative real-world evidence platforms to monitor vaccine performance post authorization: DRIVE - a European initiative

Cited by 5 publications

References 20 publications

Development of medicines for rare diseases and inborn errors of metabolism: Toward novel public–private partnerships

Development of medicines for rare diseases and inborn errors of metabolism: Toward novel public–private partnerships

Brand-specific estimates of influenza vaccine effectiveness for the 2021–2022 season in Europe: results from the DRIVE multi-stakeholder study platform

Seasonal Influenza Vaccine Effectiveness in Persons Aged 15–64 Years: A Systematic Review and Meta-Analysis

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