This action supports the policy priority to be better prepared to respond to serious cross-border health threats. It contributes to the achievement of the EU4Health Programme’s general objective of protecting people in the Union from serious cross-border threats to health and strengthening the responsiveness of health systems and coordination among the Member States to cope with serious cross-border threats to health (Article 3, point (b), of Regulation (EU) 2021/522) through the specific objectives defined in Article 4, points (b) and (c), of Regulation (EU) 2021/522.

Scope:

This action aims to diversify and advance the pipeline of BSA candidates. More specifically, it will support the development and further characterisation of broad-spectrum antivirals targeting identified HERA priority viral families, which largely can be divided among respiratory RNA viral families, such as Paramyxo-, Orthomyxo and Coronaviridae, as well as those targeting viral families known for causing viral haemorrhagic fever (VHF), such as Arena-, Bunya-, Flavi-, Filoviridae. The action aims to identify a potent BSA candidate, in order to advance its clinical development. A robust pipeline should contain multiple BSA candidates for each viral family that are developed in parallel. When selecting the BSA candidate, attention will be paid to the complementarity with existing Horizon Europe projects.

The proposal would need to cover early safety and efficacy trials for testing new or improved anti-viral therapeutics, with a clear regulatory and clinical pathway, including first in humans.

Innovative delivery systems and suitable safety profiles for broad use should be considered when possible as well as the application of novel approaches and widely applicable workflows (e.g. artificial intelligence) for rapid and reliable identification of broad-spectrum anti-viral therapeutics.

Expected Impact:

HERA’s threat assessment of 2022 included a vulnerability analysis with regard to the availability or absence of medical countermeasures, in particular the availability of vaccines and treatment options. Given that the large majority of identified virus families lack effective vaccines and/or effective therapeutics at the EU and global levels, HERA’s long-term aim is to, inter alia, support the creation of a diverse portfolio of BSAs and BCCs that can be further developed in clinical by identifying most promising candidates and supporting their characterisation and assessment, including through clinical trials. Actions funded under this topic are therefore expected to either bring innovative, emerging, and cutting-edge elements with significant economic potential to the internal market or to reduce or prevent strategic dependencies of the Union, including by contributing to the Union's technological leadership in the innovation and development of BSA and enhancing the access to these products in the EU.