The objective of this call is to conclude service contracts for the procurement of clinical and non-clinical services to accelerate the availability of and access to innovative medical countermeasures (MCM) to diagnose/detect, prevent, protect against or treat conditions associated with serious cross-border health threats.
HaDEA implements the EU4Health programme by managing calls for proposals and tenders from 2021 to 2027. In this occasion it has published a Prior Information Notice (PIN) for a call for tenders to be funded under the EU4Health 2023 Annual Work Programme with an estimated budget of 82 million euros. The programme and its calls represent an ambitious response to the COVID-19 pandemic, but go beyond crisis response to address the resilience of European healthcare systems and contribute to a healthier Europe.
The call is subdivided into four different lots:
Lot 1 - Vaccines to Combat Antimicrobial Resistance. It will support the assessment of the vaccine candidate’s efficacy and safety (within Phase II clinical trials), as well as any development that helps identify the most promising preparation, dose, and schedule to be tested in Phase III clinical trials, related to antimicrobial resistance.
Lot 2 - Broad Spectrum Antivirals Targeting Respiratory RNA Viral Families. It will support the assessment of the candidate’s efficacy and safety (within Phase II clinical trials) to foster the development of broad-spectrum antivirals targeting respiratory RNA viral families, mainly, but not limited to, Paramyxo-, Orthomyxo- and Coronaviridae, as well as any development that helps to identify the most promising preparation, dose, and schedule, to be tested in Phase III clinical trials.
Lot 3 - Broad Spectrum Antivirals – Viral-haemorrhagic Fevers. It will support the assessment of the candidate’s efficacy and safety (within Phase II clinical trials) to foster the development of broad-spectrum antivirals targeting RNA viral families known for causing viral haemorrhagic fever (mainly, but not limited to, Arena-, Bunya-, Flavi- and Filoviridae), as well as any development that helps identify the most promising preparation, dose, and schedule, to be tested in Phase III clinical trials.
These two lots foresee support to obtain partial information on drug efficacy, namely ‘Phase IIb’ clinical trials, for contexts where viral diseases occur with relevant incidence. When relevant and duly justified (e.g., lack of commercial interest or another type of market failure that leads to crowding out investments and partnerships), tenderers may also apply for partial support for the assessment of a primary efficacy endpoint of Phase III trials, specifying the measure of the disease-related outcome of public health interest, such as mortality or disease morbidity, that supports the antiviral candidate indication for use.
Lot 4 - Point of Care Metagenomic Sequencing for Universal Pathogen Detection. It will support the development and certification of a metagenomic next-generation sequencing (mNGS)-based device for point-of-care infectious disease diagnostics and early outbreak detection. The device will be able to detect any respiratory viral pathogen, including novel and emerging, delivering a result readable to clinicians within hours while being cost-competitive with current molecular diagnostics.
