Consortium Secures EU Tender for Influenza Preparedness
Australian biotechnology firm Vaxxas Pty Ltd, in collaboration with SK bioscience and IDT Biologika, has been awarded a Phase One tender by the European Health and Digital Executive Agency (HaDEA). This significant tender, awarded on behalf of the Health Emergency Preparedness and Response Authority (HERA), is a crucial part of the EU 2024 EU4Health Work Programme.
The programme allocates up to A$250 million across three competitive phases, with the overarching goal to strengthen Europe's preparedness against future seasonal and pandemic influenza threats.
Phase One Funding and Objectives
Phase one funding amounts to €12.9 million (approximately A$22 million). This substantial investment will support the consortium in advancing Vaxxas’ high-density microarray patch (HD-MAP) technology alongside SK bioscience’s seasonal influenza vaccine through a Phase I clinical study.
The program also includes pre-clinical development for a "clinic ready" HD-MAP designed for pre-pandemic influenza.
The funding specifically supports vaccines designed for easier administration via alternative delivery platforms, such as Vaxxas’ needle-free patch, and those capable of rapid scaling in emergencies.
Leadership Comments on Innovation and Preparedness
Vaxxas CEO Mr. David Peacock stated that the successful tender reflects a shared ambition across the Consortium and the European Union to invest in alternative vaccine delivery technologies that simplify vaccination and enhance preparedness. He further added that the tender positions Vaxxas and its partners at the forefront of global vaccination innovation.
Dr. Sally Choe, co-CEO of IDT Biologika, indicated that by working with SK bioscience and Vaxxas, they are actively helping to develop new vaccination approaches. Jaeyong Ahn, president and CEO of SK bioscience, commented that the project demonstrates their combined global network and technological capabilities.
Building on Existing Momentum and Technology Advantages
This European award builds on existing initiatives for Vaxxas, which is currently completing a large Phase I clinical study of its HD-MAP with a pre-pandemic influenza vaccine, backed by the US Government’s Biomedical Advanced Research and Development Authority (BARDA).
A key advantage of the HD-MAP platform is its potential to simplify vaccine logistics. Previously published data has shown that an influenza vaccine delivered via the HD-MAP platform can maintain stability at 40°C for up to 12 months, potentially removing the need for continuous refrigeration and simplifying storage and distribution.
Consortium Roles and Future Outlook
Germany-based IDT Biologika, a contract development and manufacturing organization specializing in vaccines, gene, and immune therapeutics, led the consortium submission. SK bioscience will supply vaccine antigens for both seasonal and pandemic influenza studies, leveraging its proprietary cell culture technology.
All clinical product for phase one will be manufactured at Vaxxas’ biomedical facility in Brisbane. If phase one is completed successfully, the consortium will be eligible to tender for later stages, including late-stage clinical trials, marketing authorization, and the establishment of sovereign EU manufacturing capability.