Development of novel vaccines for viral pathogens with epidemic potential

While the participation of countries where the viruses listed are endemic or where outbreaks have occurred or are ongoing is indeed encouraged in the topic text, this does not make all entities from these countries automatically eligible for funding.

Entities established in countries explicitly listed on pages 12 and 13 of the General AnnexesPDF to the Work Programme are eligible for funding.

Legal entities which are established in countries not listed on pages 12 and 13 of the General AnnexesPDF to the Work Programme be eligible for funding if their participation is considered essential for implementing the action by the granting authority.

No, this topic is not using the Lump Sum funding model.

Please note that the definition of clinical studies, together with additional useful information can be found in the introduction of Health Cluster Work Programme part for 2026-2027.

Additionally, we would like to bring to your attention the fact that the World Health Organization (WHO) has published a “Guidance for best practices for clinical trials”. You are not required not follow this guidance, however we encourage you to do so.

Finally, we would also like to encourage you to consider the latest innovations and advances in the clinical trial design and research methods in order to evaluate promising interventions allowing shorter development timings.

Applicants must specify in their proposal which virus is being targeted as required in the topic text. However, the topic does not exclude assessing whether the selected vaccine candidates might also have a broader, cross‑ or pan‑protective effect, provided that the core work in the proposal focuses on one of the viruses, as specified in the topic text. Any work on additional viruses should remain marginal.

The topic description specifies that proposals should address the entirety of the listed research areas. One of these areas is “first‑in‑human clinical safety studies”, which are components of phase I trials. Hence, GMP manufacturing, without inclusion of such clinical studies, will not be sufficient for proposals to be considered fully in scope. Please bear in mind, however, that the evaluation of the proposals submitted is performed by a panel of independent experts, thus it will be up to them to evaluate whether the topic requirements are fully addressed.

For details on how the portfolio condition is applied to this topic, please contact your National Contact Point (EU Funding & Tenders Portal).

The topic focuses on advancing existing prophylactic and therapeutic vaccine candidates that are already at an advanced preclinical stage. In contrast, a One Health approach is usually integrated much earlier in the development pipeline, for example when prioritising target pathogens or designing immunogens with cross-species relevance.

The topic requires the development of novel vaccines based on existing vaccine candidates. These are not mutually exclusive: an “existing” vaccine candidate can still be in late preclinical development and, at the same time, represent a genuinely novel vaccine or platform that does not currently exist in the market.

The expectation is that proposals will actually start from existing vaccine candidates since applicants are requested to start from the "finalisation of in-vitro characterisation of existing vaccine candidates". The point is that at the end, proposals should deliver novel vaccines, that are different from the ones already in the market.

The Health Cluster Work Programme part for 2026-2027 includes a “right to object” condition for nearly all topics, giving the granting authority the right to object to a transfer of ownership or to the exclusive licensing of results, up to 4 years after the end of the action.

For applicants and beneficiaries, little is expected to change, as in previous years this condition had been part of the General Annexes, having legal force across all parts of Horizon Europe (including the Health Cluster topics). In practise, the granting authority may invoke the “right to object” under specific conditions, which so far has happened in very rare occasions over the many years of Horizon Europe.

More details below from Annex 5 of the General Model Grant Agreement:

Where the call conditions in Horizon Europe actions provide for the right to object to transfers or licensing, the granting authority may — up to four years after the end of the action — object to a transfer of ownership or the exclusive licensing of results, if:

the beneficiaries which generated the results have received funding under the grant

it is to a legal entity established in a non-EU country not associated with Horizon Europe, and

the granting authority considers that the transfer or licence is not in line with EU interests.

Beneficiaries that intend to transfer ownership or grant an exclusive licence must formally notify the granting authority before the intended transfer or licensing takes place and:

identify the specific results concerned

describe in detail the new owner or licensee and the planned or potential exploitation of the results, and

include a reasoned assessment of the likely impact of the transfer or licence on EU interests, in particular regarding competitiveness as well as consistency with ethical principles and security considerations.

The granting authority may request additional information.

If the granting authority decides to object to a transfer or exclusive licence, it must formally notify the beneficiary concerned within 60 days of receiving notification (or any additional information it has requested).

No transfer or licensing may take place in the following cases:

pending the granting authority decision, within the period set out above

if the granting authority objects

until the conditions are complied with, if the granting authority objection comes with conditions.

A beneficiary may formally notify a request to waive the right to object regarding intended transfers or grants to a specifically identified third party, if measures safeguarding EU interests are in place. If the granting authority agrees, it will formally notify the beneficiary concerned within 60 days of receiving notification (or any additional information requested).