HaDEA has published the EU4Health Prior Information Notice HADEA/2025/OP/0013-PIN to speed up the access to and/or uptake of innovative Mpox vaccines.

The objective of this call for tender will be to strengthen the scientific evidence on the immunity provided by the Modified Vaccinia Ankara virus-Bavarian Nordic (MVA-BN) vaccine, with particular emphasis on the need and optimal timing of booster doses. Therefore, the purpose of this call for tenders will be to purchase clinical services for clinical research and/or other equivalent scientific activities to evaluate and compare the immunogenicity of a booster dose of MVA-BN vaccine considering different routes of administration, namely intradermal and subcutaneous injection, and the appropriate timing of the booster dose. The activities under this call are expected to include a Phase II and/or Phase III clinical trial(s).

The results of the clinical study(ies)/trial(s) should be able to contribute to the development and refinement of vaccination strategies to be adopted by public health authorities, as well as to provide further evidence for the European Commission and EU countries to consider when developing relevant policies, e.g. on stockpiling initiatives, and/or the feasibility of dose-sparing strategies for Mpox vaccination during shortages.

This action will support the policy priority to enhance the availability and accessibility of medical countermeasures and critical medicines, to support innovation and access regarding such products and to ultimately enhance preparedness for future health emergencies in synergy with Horizon Europe. It implements the EU4Health Programme’s general objective of improving the availability, accessibility and affordability of medicinal products and medical devices and crisis-relevant products (Article 3, point (c), of Regulation (EU) 2021/522) through the specific objectives defined in Article 4, points (b) and (c), of Regulation (EU) 2021/522

Indicative budget: €4 900 000

Interested parties are invited to check the Funding and Tenders Portal for the future publication of the call.

Background

EU4Health is the fourth and largest of the EU health programmes. The EU4Health programme goes beyond an ambitious response to the COVID-19 crisis to address the resilience of European healthcare systems. The programme provides funding to national authorities, health organisations and other bodies through grants and public procurement, contributing to a healthier Europe. HaDEA manages the vast majority of the total EU4Health budget and implements the programme by managing calls for proposals and calls for tenders from 2021 to 2027.