Call for Proposals on the European Hub for Vaccine Development

Deadline: 5-Sep-24

The European Commission (EC) has announced a call for proposals on the European Hub for vaccine development.

Objectives 

• This action supports the policy priority to enhance crisis preparedness and response for future health emergencies in relation to medical countermeasures, with a focus on priority pathogens with pandemic potential. It implements the EU4Health Programme’s general objective of improving the availability, accessibility and affordability of crisis-relevant products (Article 3, point (c)) through the specific objectives defined in Article 4, points (b) and (c), of Regulation (EU) 2021/522.

Strand (scope) 

• Crisis preparedness

Funding Information

• The estimated available call budget is EUR 149 000 000.
• Topic budget: EUR 102.000.000
• Indicative project budget: EUR 102.000.000
• Expected number of grant agreements to be signed: 1
• Duration: 48 months

Expected Impact 

• This action is expected:
  • to contribute to better preparedness and early response to health emergencies;
  • to increase the availability and uptake of public health relevant vaccines and antibodies;
  • to contribute to the availability of preventive measures to slow the spread of selected pathogens;
  • to reduce strategic dependencies, expand Europe’s competitiveness and strategic autonomy.

Activities that can be funded 

• This action aims to create a European Hub for public health relevant vaccine development, combining excellence in vaccine development with clinical trials and activities for scaling manufacturing. This call targets consortia of developers of vaccines covering expertise in development including publicly funded and industrial organisations.
• The Hub will develop a strategic vaccines plan for Europe, and subsequently deliver on creating vaccine prototypes in particular for priority pathogens with epidemic and pandemic potential, further developing of state-of-the-art technologies that can be rapidly adapted, preparing relevant master clinical trial protocols, combining its activities to reach out to clinical trial capacities/networks and at scale production initiatives at national and European levels. The Hub should establish connections with the future Horizon Europe-funded European Partnership on Pandemic Preparedness (HORIZON-HLTH-2024-DISEASE-12-01) and private manufacturers including through specific manufacturing agreements such as EUFAB or comparable national models.

Specific mandatory deliverables and/or milestones

• A European Vaccine Hub will be an excellence based – Public Health focused – infrastructure that develops vaccine prototypes of selected pathogens to phase 2, and prepares processes that guarantee at scale production by industry partners under outbreak conditions. In addition, the Hub will be at the origin of technology spin-offs contributing to the development of vaccines against other high-impact, also nonpandemic pathogens.
• The Hub will contribute to the coordination of different pandemic vaccine development programmes and projects by reviewing and advising on progression along all phases of the product development cycle. The Hub will ensure an appropriate pre-regulatory pipeline for selected vaccines in public interest.
• These capacities culminate in a consortium that ensures all preparatory work for the development of vaccine-based countermeasures at the necessary scale. The Hub aligns its different bodies´ activities from discovery research to the development and production of trials vaccines, design and development of relevant clinical and biological assays as well as contracting manufacturers for production at scale. The Hub should link strongly innovative teams working on designated pathogens, on different vaccine technologies, while expanding work also to improving the value chain for antibodies. The Hub should establish functional links with relevant international partners and with like-minded organisations undertaking similar activities, to seek for synergies and acceleration of processes. This should be described as part of the governance structure of the proposal.
• All activities carried out by the EVH should contribute to the development of an agreed set of public health-relevant prototype vaccines and scalable technologies through a consortium of major EU Vaccine R&D institutions and manufacturers (including effective coordination of national vaccine programmes). The EVH will coordinate robust vaccine development from prototype design to clinics, to accelerating innovations, and clinical evaluation capacities, will work on the coordination with manufacturers, and digitalisation of design and development processes and distribution solutions. The EVH should:
  • Develop and implement a pandemic vaccines readiness plan: In the context of an epidemic or pandemic, the consortium integrates dispersed efforts into one single targeted workstream to design, develop, and enable manufacturing of candidate vaccines (or antibodies) for preventive or therapeutic purposes. This should be done in coordination with the future Horizon Europe-funded European Partnership on Pandemic Preparedness (HORIZON-HLTH-2024-DISEASE-12- 01).
  • Develop pandemic vaccines candidates for agreed pathogens along all phases up to phase 2, including through relevant in vitro, in vivo and animal models. Collaboration with European Research Infrastructures, e.g. through ISIDORe, should be sought.
  • Ensure rapid delivery of vaccine candidates for trial and mass production to manufacturing partners, including those covered by EU FAB or similar national contracts or other relevant capacities.
  • Optimise digitalisation of discovery, development and production technologies of vaccines.
  • Organise and optimise the clinical evaluation of candidate vaccines among its constituents including in Phases I and II and the appropriate use of controlled infection facilities in close collaboration with the future Horizon Europe-funded European Partnership on Pandemic Preparedness (HORIZON-HLTH-2024- DISEASE-12-01). Contribute to the Partnership’s “ever-warm” clinical trials system for vaccines (and antibodies) ready, audited and tested. Provide trainings for all aspects around optimisation of clinical trials organisation.
• Specific deliverables:
  • ad-hoc reports, studies (related to data analysis) and advice on relevant aspects linked to the project (e.g. vaccine design, development, production and deployment in preparedness and crisis times).
  • An EU epidemic and pandemic vaccines readiness plan, implementation plan and progress reports on implementation.
  • List of priority pathogens for development of epidemic and pandemic vaccine prototypes to be agreed by HERA.
  • Processes and procedures to ensure rapid development and delivery of vaccine candidates for trial and mass production. Including written agreements with respective trial and manufacturing partners.

Eligibility Criteria

• In order to be eligible, the applicants (beneficiaries and affiliated entities) must:
  • be legal entities (public or private bodies)
  • be established in one of the eligible countries, i.e.:
    • EU Member States (including overseas countries and territories (OCTs))
    • eligible non-EU countries:
      • listed EEA countries and countries associated to the EU4Health Programme

For more information, visit EC.