Description

HORIZON-HLTH-2026-01-DISEASE-04

Expected Outcomes

This topic contributes to the Horizon Europe destination “Tackling diseases and reducing disease burden.” Proposals must deliver results that achieve both of the following outcomes:

• Improved scientific and clinical knowledge
  • Enhanced understanding of experimental vaccines for prevention and treatment of emerging or re-emerging viral infections.
  • Better insight into how biological sex and social determinants affect immune response, vaccine efficacy, safety, and uptake.
  • Expanded access for further clinical investigation.
• Availability of candidate vaccines
  • Advanced vaccine candidates ready for clinical deployment.
  • Increased therapeutic options in the event of epidemics or pandemics.

Policy Context

• Infectious diseases remain a major threat to EU and global health security.
• Climate change is accelerating viral emergence.
• Proactive vaccine R&D is critical for preparedness.
• Adaptable vaccines capable of responding to variants are a strategic priority.
• The topic supports:
  • The European Medical Countermeasures Strategy
  • Strengthening the EU Research & Innovation ecosystem

Target Viruses

Applicants must select one (and only one) of the following viruses and focus exclusively on it:

• Junin mammarenavirus
• Lassa mammarenavirus
• Andes virus
• Hantaan virus
• Sin Nombre virus
• Hendra virus
• Enterovirus D68
• Venezuelan equine encephalitis virus

The objective is to diversify and accelerate the global vaccine R&D portfolio while reinforcing EU leadership in antiviral innovation.

Mandatory Research Areas

Proposals must address all of the following:

1. In-Vitro Characterisation

• Finalisation (if needed) of target specificity analysis
• Epitope mapping
• Assessment of viral inhibition or inactivation capacity

2. In-Vivo Studies

• Testing in at least one animal model
• Use of humanised immune system models where available
• Demonstration of protective efficacy prior to first clinical trials
• Non-human primate studies if required by regulators

3. GMP Manufacturing

• Production of vaccine batches compliant with Good Manufacturing Practices (GMP)

4. First-in-Human Clinical Studies

• Initial safety trials
• Clear regulatory pathway toward market authorisation
• Consideration of biological and social variables, including:
  • Sex
  • Age
  • Ethnicity
  • Disability

Additional Requirements & Recommendations

• International collaboration is encouraged, particularly with countries where the virus is endemic or outbreaks have occurred.
• Engagement with regulatory authorities is mandatory and must occur early.
• Projects should leverage state-of-the-art research infrastructures, including those linked to ESFRI and ISIDORe.
• The European Commission’s Joint Research Centre (JRC) may contribute, particularly in innovative in-vitro biotechnologies and strategic technologies.
• Participation of start-ups and SMEs is encouraged to strengthen innovation and commercialisation pathways.
• Clinical study details must be provided using the dedicated annex template in the submission system.

Strategic Impact

Funded projects are expected to:

• Strengthen EU pandemic preparedness
• Expand therapeutic and prophylactic vaccine pipelines
• Improve regulatory readiness
• Enhance global response capacity for emerging viral threats