Building Europe’s vaccine readiness – insights from HORIZON-HLTH-2026-01-DISEASE-04
31st October 2025 at 9:53 am
The COVID-19 pandemic revealed both the power and the fragility of global vaccine systems. Rapid vaccine innovation saved lives but also exposed the need for sustainable, long-term preparedness. The European Commission is addressing this gap through the HORIZON-HLTH-2026-01-DISEASE-04 call topic, which funds the development of novel vaccines for viral pathogens with epidemic potential. Under this Research and Innovation Action (RIA), five projects of between € 9.00 and 11.00 million are expected to be funded. With six months left until the deadline on 16 April 2026, there is plenty of time to put together a competitive consortium and prepare your application. Dive into this blog post to learn how your Horizon Europe proposal can support the EU’s preparedness agenda by advancing candidate vaccines from preclinical testing to first-in-human studies.
1. Why vaccine preparedness matters now
Emerging and re-emerging viruses continue to pose unpredictable threats, fuelled by climate change, population mobility and ecosystem disruption. The call explicitly targets eight viruses with proven or suspected epidemic potential:
- Junin mammarenavirus
- Lassa mammarenavirus
- Andes virus
- Hantaan virus
- Sin Nombre virus
- Hendra virus
- Enterovirus D68
- Venezuelan equine encephalitis virus
Proposals must select one of these viruses and work exclusively on existing prophylactic or therapeutic vaccine candidates. The goal is to expand Europe’s preparedness portfolio so that, when outbreaks occur, vaccines are already characterised, tested and ready for rapid clinical deployment. Therefore, we recommend you align your objectives with the missions of the Health Emergency Preparedness and Response Authority (HERA) and the European Centre for Disease Prevention and Control (ECDC) agency. Evaluators appreciate projects that anticipate regulatory and production needs before crises strike.
2. Strengthening Europe’s vaccine pipeline
This call builds on Europe’s leading role in vaccine science and biomanufacturing. Applicants are expected to diversify and accelerate the vaccine development portfolio for the targeted viruses. Proposals should integrate all essential stages from laboratory validation to early clinical studies. Key expectations include:
- Final in-vitro characterisation of vaccine candidates, confirming epitope targets and viral inhibition capacity, if necessary.
- In-vivo validation in suitable animal models, ideally humanised immune system models when available.
- Non-human primate studies, only if regulators require them before clinical testing.
- GMP production of the most promising candidates according to the Good Manufacturing Practices (GMP).
- First-in-human clinical safety studies that demonstrate feasibility and define a clear pathway to market authorisation.
Including a transparent go/no-go strategy for progressing candidates through preclinical milestones shows evaluators that your consortium can manage risk and prioritise resources efficiently.
3. Addressing diversity, ethics and equity
The call stresses the importance of integrating biological and social determinants into vaccine research. Sex, age, ethnicity and disability can influence immune responses, vaccine uptake and trial participation. Therefore, proposals should:
- Include sex and gender analysis in both preclinical and clinical phases.
- Plan inclusive recruitment strategies for first-in-human trials.
- Consider social and behavioural aspects that may affect vaccine acceptance.
- Integrate ethics oversight early to anticipate challenges in emergency vaccine deployment.
- Explicitly reference EU guidance on sex and gender in research design. This aligns with Horizon Europe evaluation criteria and can strengthen your impact and excellence scores.
4. Leveraging EU and global infrastructures
The call encourages use of existing and emerging research infrastructures, especially those developed under the ISIDORe project, which coordinates European services for infectious disease preparedness. Leveraging these facilities can shorten timelines, improve data comparability and reduce duplication. Examples of the use of such infrastructures include:
- Use available high-containment labs, clinical trial networks and biomanufacturing hubs.
- Establish links with global partners in endemic regions to improve field relevance.
- Incorporate data sharing mechanisms and align with FAIR principles for interoperability.
- Collaborating with third-country partners strengthens both scientific value and policy impact. It shows awareness of real-world outbreak dynamics and supports equitable access to future vaccines.
5. Building strong, agile consortia
Successful proposals will bring together universities, clinical centres, SMEs, regulators and international partners. Each brings unique value to the vaccine pipeline, and their roles must be clearly defined to ensure complementarity. In addition, applicants can consider to:
- Include SMEs with GMP and manufacturing expertise to secure production capacity.
- Engage regulatory advisers to guide study design and documentation.
- Appoint a clinical lead experienced in early-phase vaccine trials.
- Build flexibility into your governance model. The EC values consortia that can adapt rapidly to evolving data and regulatory feedback.
Looking for proposal writing support from experts with biomedical experience?
Since our foundation, we have been collaborating with more than 1,000 organisations in Europe and beyond. Our track record includes Horizon Health RIAs such as EXPOSIM, EU PAL-COPD, GLIOMATCH, GENEGUT and MyPath. Additionally, our support extends to many more health-focused ITNs, including MITGEST and MobiliTraIN, as well as Pathfinder-Open projects related to health, such as POLINA and BoneOscopy.
The HORIZON-HLTH-2026-01-DISEASE-04 call embodies Europe’s shift from reactive response to proactive readiness. Are you ready to start working on a proposal? Get in touch with our Horizon Health experts to see how we can support you in turning your idea into a competitive Horizon Europe proposal.
