Integration across the end-to-end vaccine development pipeline
To ensure the EVH functions as a truly integrated, agile, and sustainable infrastructure, a set of horizontal WPs has been established to support and reinforce the entire end-to-end vaccine development process. These cross-cutting activities are essential to the operational coherence, scientific excellence, and long-term resilience of the EVH.
The activities within horizontal WPs are not confined to a single phase of vaccine development. Instead, they operate across all Pillars - discovery, pre-clinical, clinical, and manufacturing - ensuring that the EVH remains aligned with its strategic objectives and capable of responding rapidly to emerging health emergencies.
WP1 Coordination, management, and impact assessment (Lead: SVA)
- Coordinate and manage the project, including scientific, technological and administrative oversight
- Guarantee the successful progress of the project within the agreed time, cost and quality limits
- Foster collaboration and international cooperation
- Assess the EVH Project impact
WP2 Dissemination, communication, training and stakeholder engagement (Lead: SVA; All Partners involved)
- Establish effective communication among the consortium Partners
- Establish and implement effective dissemination and communication activities to maximise the project impact
- Establish an appropriate dissemination strategy for ensuring sustainability and long-term impact
- Communicate to the multiple audiences (stakeholders, policy makers and public) in a strategic and effective manner
WP3 Data management, AI (Lead: DZIF; Partners involved: SVA, UMR, HMGU, HZI, IP)
- Develop robust and resilient data infrastructures that can respond adaptively to the specific challenges of a pandemic phase
- Create a User Portal with a dashboard that connects the data streams generated in the consortium with the consortium members and decision-makers according to current needs
- Ensure fair access to data, documents, and tools and guarantee easy retrieval of data elements generated in the consortium
- Increase interoperability between trials, pandemic preparedness and exploratory biomarker identification and validation across trials
- Produce the EVH Data Management plan
WP16 Industry, IPRs, TT (Lead: DZIF; Partners involved: SVA, UMR, ZEPAI, FBS)
- Create a transparent public-private partnership (PPP) to prepare accelerated development in the event of pandemics
- Create a flexible instrument for rapid and flexible inclusion of Small and medium-sized enterprises (SMEs) in particular small biotechs with high innovation potential
- Build a network to foster collaboration between the Contract Research Organizations (CROs), Contract Development and Manufacturing Organizations (CDMOs), public research institutions and the private R&D and manufacturers
- Implement an instrument for gap analysis to identify missing capacities, skills and expertise as a fundament for PPP development
- Define the legal and intellectual property (IPr) framework to ensure rapid access to technologies and data in the event of a pandemic
- Prepare technology transfers (TTs) for mass production, sharing knowledge, methods, and tools from research and development teams to manufacturing partners
WP17 Vaccine readiness plans for Europe (Lead: SVA; Partners involved: UMR, ZEPAI, UoA, ULB, LUMC, FBS, IP, NIPH, Pasteur Network).
- Agree on and define at EU level standardised procedures and protocols for rapid decision making and implementation during health emergencies including a set public health-relevant prototype vaccines, scalable technologies and processes to anticipate future pandemics
- Development of EU epidemic and epidemic vaccines readiness plan
- Coordinate the multiple EU initiatives and stakeholders at EU to ensure a strategic autonomy against new pandemic threat: substantial manufacturing capacities in the EU, paired with the best research and development capacities, swift clinical trial networks and fast and non-controversial regulatory processes
- Integrate of dispersed efforts into one single targeted workstream to design, develop, and enable manufacturing of candidate vaccines (or antibodies) for preventive or therapeutic purposes
- Test and communicate the method for accelerating vaccine and H-mAbs development and availability in real conditions
- Develop a sustainability plan to ensure the long-term sustainability of EVH