The European Health and Digital Executive Agency (HaDEA) has published three Prior Information Notices (PINs) under the EU4Health programme, signalling upcoming calls for tenders in key areas of health innovation. These calls aim to accelerate the development of next-generation influenza vaccines, advance mpox vaccine research, and develop rapid point-of-care antimicrobial susceptibility testing (AST) devices, contributing to greater pandemic preparedness and antimicrobial resistance (AMR) mitigation.
- Next generation influenza vaccines
HaDEA has issued PIN HADEA/2025/CPN/0008-PIN, outlining a future call for tenders on multiple sourcing framework contracts aimed at speeding up the development and access to innovative influenza vaccines.
The objective is to advance vaccine platforms that offer rapid scalability—such as nucleic acid-based approaches, cell culture production, plant-based production, or in vitro transcription—as well as vaccines that:
- Utilise novel administration routes (e.g., nasal, oral, or microneedle patches).
- Confer mucosal immunity for broader protection.
- Target potentially pandemic influenza A viruses and adapt swiftly to emerging strains.
- Offer cross-subtype protection or alpha-influenza virus coverage.
- Achieve intrinsic immunogenicity without adjuvants.
This initiative supports EU policies aimed at enhancing the availability, accessibility, and innovation of medical countermeasures, reinforcing Europe's preparedness for future health crises. It is aligned with the EU4Health Programme’s objectives (Regulation (EU) 2021/522) and complements the Horizon Europe research framework.
Indicative budget: EUR 147 951 410 (indicative ceiling for each of the framework contracts to be signed). The call is anticipated to be published in April 2025.
- Rapid point-of-care AST devices to tackle AMR
The PIN HADEA/2025/CPN/0006-PIN notice anticipates a call for tenders dedicated to developing rapid antimicrobial susceptibility testing (AST) medical devices. The goal is to significantly reduce the time required for AST results, ensuring timely and targeted treatment decisions in clinical settings.
The tender will seek innovations that:
- Deliver AST results within one hour or less from sample collection.
- Ideally, also identify pathogens responsible for infections.
- Ideally, cover WHO-listed priority bacterial pathogens and fungal pathogens such as Candida spp. and Aspergillus fumigatus.
- Demonstrate a clear pathway towards CE marking in the EU and aim for Technology Readiness Level (TRL) 8 by contract completion.
This initiative is a critical step in combating antimicrobial resistance (AMR) by fostering the development of fast and reliable diagnostic solutions.
Indicative budget: EUR 12 860 000. The call is anticipated to be published in April 2025.
- Speed up the access to and uptake of a mpox vaccine
The HADEA/2025/OP/0013-PIN about advancing mpox vaccine research aims to strengthen scientific evidence on the immunity provided by the Modified Vaccinia Ankara virus-Bavarian Nordic (MVA-BN) vaccine, focusing on the need, optimal timing and safety of booster a dose.
The objectives of the tender are to:
- Assess immunogenicity and safety of an MVA-BN booster dose, comparing intradermal and subcutaneous injection routes.
- Determine the optimal timing for administering a booster dose.
- Conduct phase II and/or phase III clinical trials to generate robust scientific data.
- Support public health decision-making on mpox vaccination strategies, stockpiling policies, and dose-sparing approaches in case of shortages.
This initiative aligns with the EU’s policy priority to improve the availability and accessibility of medical countermeasures and critical medicines, fostering innovation and equitable access to these essential products.
Indicative budget: EUR 4 900 000. The call is anticipated to be published in March 2025.
HERA encourages companies, research institutions, and innovators to explore these forthcoming opportunities, and leverage these initiatives to contribute to advancing health security and innovation.
For more details and updates, please visit the EU Funding and Tenders Portal.
More information:
- HERA Factsheet: Medical countermeasures, guaranteeing an arsenal in times of need and boosting innovation
- HERA Response
- HERA preparedness - Promoting advanced R&D of medical countermeasures and related technologies
- HaDEA news announcement - Prior Information Notice - EU4Health call for tenders on the development of a rapid point-of-care antimicrobial susceptibility testing diagnostic medical device
- HaDEA news announcement - Prior Information Notice - EU4Health call for tenders on Framework Contracts to speed up the development of next-generation influenza vaccines
- HaDEA news announcement – Prior Information Notice - EU4Health call for tenders to speed up the access to and/or uptake of innovative Mpox vaccines
Details
- Publication date
- 4 March 2025
- Author
- Health Emergency Preparedness and Response Authority