Periodic Reporting for period 1 - EVORA (European Viral Outbreak Response Alliance)
Okres sprawozdawczy: 2024-01-01 do 2025-06-30
EVORA brings together EVA, ERINHA and ELIXIR, three complementary reference research infrastructures (RIs) in viral resource provision, access to high containment services, and management solutions for large-scale life science data, respectively. EVORA aims to provide the EU with a comprehensive, operational and coordinated framework for pandemic preparedness and response to viral threats.
A lesson learnt during the Covid-19 crisis is that RIs face bottlenecks during outbreak times, independently of their great efforts and expertise. These are often linked to the necessity to rapidly adapt work to an unforeseen intensity, while continuing non-pandemic-related research activities. EVORA aims to create a continuum of services for fundamental and pre-clinical research, offered to researchers through a online catalogue of integrated access to resources, high-containment facilities and embedded data management solutions, as a fluent pipeline for performing research during inter-crisis times or viral outbreak.
The strategic objectives of EVORA are to strengthen the EU capacity for pandemic preparedness research and response to viral diseases, unify RI operations for optimal responsiveness, sustainability and competitiveness, and address regulatory, ethical, and security challenges raised by EVORA’s service offer.
Expected results include operative governance between the three RIs, allowing concerted decision-making according to research needs, integrated service offer and improved users’ navigation through a complex regulatory environment. EVORA will contribute to strengthening the competitiveness of the European Research Area (ERA) by providing operational state-of-the-art facilities, supporting European industry in the field of communicable diseases and to providing recommendations for harmonised policies and regulations.
A lesson learnt during the Covid-19 crisis is that RIs face bottlenecks during outbreak times, independently of their great efforts and expertise. These are often linked to the necessity to rapidly adapt work to an unforeseen intensity, while continuing non-pandemic-related research activities. EVORA aims to create a continuum of services for fundamental and pre-clinical research, offered to researchers through a online catalogue of integrated access to resources, high-containment facilities and embedded data management solutions, as a fluent pipeline for performing research during inter-crisis times or viral outbreak.
The strategic objectives of EVORA are to strengthen the EU capacity for pandemic preparedness research and response to viral diseases, unify RI operations for optimal responsiveness, sustainability and competitiveness, and address regulatory, ethical, and security challenges raised by EVORA’s service offer.
Expected results include operative governance between the three RIs, allowing concerted decision-making according to research needs, integrated service offer and improved users’ navigation through a complex regulatory environment. EVORA will contribute to strengthening the competitiveness of the European Research Area (ERA) by providing operational state-of-the-art facilities, supporting European industry in the field of communicable diseases and to providing recommendations for harmonised policies and regulations.
EVORA has implementing the project task according to the EC rules and the Grant Agreement (WP1). WP3, aimed to develop project visibility and identify routes for innovation and exploitation to maximise post-project impact creating an EVORA visual identity, launching the website and communication channels. Dedicated outreach to industry was initiated via the Industry Focus Group.
WP5, oversaw the creation of EVA AISBL, marking a significant milestone for the EVORA sustainability, while a first draft of a term sheet has been structured between RIs for progressively adopting a collaboration framework. WP6, aiming to consolidate and test the administrative and legal framework for operating EVORA, designed 3 virus outbreak scenarios to test the EVORA framework and gain insights into the response mechanisms of the consortium while identifying the weaknesses in coordination, including administrative and legal aspects.
WP7 focused on the creation of a unified operative language to reinforce pandemic preparedness by facilitating FAIR and open data practices in virology. A common semantic framework (ontology) for describing virology-related resources in a unified way was created, consistent with the reference taxonomy for virology (ICTV) and data deposition workflows compatible with standard repositories. WP8 assessed and supported the quality management of virus collections and biorisk management, drawing on the experience of EVA and ERINHA in applying Quality Management best practices for virus collections and for conducting experiments in high-containment settings. In addition, WP8 supported EVORA institutes in implementing the requirements of risk assessment and management for IVD-R.
EVORA WP9 aims to guide end users towards Nagoya Protocol (NP) compliance of viral resources and propose a “Roadmap for digital viral resources” for increased transparency of viral resources. The legal clarity of French resources in the EVA catalogue was improved, as France reinstated the exemption for certain microbes from the NP and Access and benefit Sharing (ABS) procedures. An open letter was sent to the WHO requesting a briefing for researchers on the next steps for the PABS negotiations. EVORA WP10, aiming to bridge the gap between ‘research use only’ laboratory developed tests and IVD-R commercial assays, in order to facilitate preparedness and response activities, drafted an IVDR requirements protocol and identified several barriers in both peace and crisis situations. Finally, WP11, addressing common ethics and security concerns related to service provision to users, has drawn on existing knowledge from EVORA partners, collecting information on guidelines, practices and procedures from institutes of the EVORA RIs on the management of in vivo studies and dual-use research in order to ensure ethical and regulatory compliance.
WP5, oversaw the creation of EVA AISBL, marking a significant milestone for the EVORA sustainability, while a first draft of a term sheet has been structured between RIs for progressively adopting a collaboration framework. WP6, aiming to consolidate and test the administrative and legal framework for operating EVORA, designed 3 virus outbreak scenarios to test the EVORA framework and gain insights into the response mechanisms of the consortium while identifying the weaknesses in coordination, including administrative and legal aspects.
WP7 focused on the creation of a unified operative language to reinforce pandemic preparedness by facilitating FAIR and open data practices in virology. A common semantic framework (ontology) for describing virology-related resources in a unified way was created, consistent with the reference taxonomy for virology (ICTV) and data deposition workflows compatible with standard repositories. WP8 assessed and supported the quality management of virus collections and biorisk management, drawing on the experience of EVA and ERINHA in applying Quality Management best practices for virus collections and for conducting experiments in high-containment settings. In addition, WP8 supported EVORA institutes in implementing the requirements of risk assessment and management for IVD-R.
EVORA WP9 aims to guide end users towards Nagoya Protocol (NP) compliance of viral resources and propose a “Roadmap for digital viral resources” for increased transparency of viral resources. The legal clarity of French resources in the EVA catalogue was improved, as France reinstated the exemption for certain microbes from the NP and Access and benefit Sharing (ABS) procedures. An open letter was sent to the WHO requesting a briefing for researchers on the next steps for the PABS negotiations. EVORA WP10, aiming to bridge the gap between ‘research use only’ laboratory developed tests and IVD-R commercial assays, in order to facilitate preparedness and response activities, drafted an IVDR requirements protocol and identified several barriers in both peace and crisis situations. Finally, WP11, addressing common ethics and security concerns related to service provision to users, has drawn on existing knowledge from EVORA partners, collecting information on guidelines, practices and procedures from institutes of the EVORA RIs on the management of in vivo studies and dual-use research in order to ensure ethical and regulatory compliance.
EVORA has increased broad visibility through WP3 actions; participation in high-level conferences, outreach events and creation of the Industry Focus Group, contributing to the scientific, societal, and industrial impact of the project. On the sustainability and operational front, WP5 and WP6 created tangible momentum across scientific, societal, and strategic domains. The formal creation of EVA AISBL positioned EVA as a legal entity capable of engaging national and European stakeholders, directly contributing to structuring the European RI ecosystem. WP6 ensured that the development of EVORA’s operational framework is informed by real-world constraints and practical testing, in order to advance EVORA’s scientific and operational readiness. WP7 provided the Virology community with a unified semantic and technical framework to support FAIR and open data practices. WP8 oversees best practices for the EVORA consortium, aligning with ISO quality standards and providing implementation guidelines to partner institutes. By promoting quality compliance of viral resources and research practices, WP8 strengthens the project’s scientific impact and supports pandemic preparedness and response. WP9 enhanced awareness of the consortium regarding the ABS regimes under CBD and WHO, and promoted increased compliance and legal clarity for the EVA catalogue. WP10 progressed towards scientific and societal impact through the development of a generic, adaptable protocol for qualifying laboratory-developed diagnostic tests to meet IVDR requirements, an important aspect for meeting the need for rapid, diagnostic capacity during public health emergencies. Finally, WP11 contributes to the scientific and societal impact of EVORA by advancing harmonised approaches to ethical and security oversight in high-containment research services. The work supports the development of standardised evaluation criteria for in vivo studies and DURC, fostering greater consistency in project selection and implementation across institutions.