a broadly protective, thermostable and rapidly deployable pre-pandemic pan-h5nx influenza vaccine with mucosal delivery potential

The global spread of H5Nx influenza, with nearly 900 reported human cases and a fatality rate exceeding 50% in major strains, underscores the urgent need for innovative vaccine solutions. The diversity of H5Nx clades causing outbreaks reveals our inability to predict which strain from which clade might become pandemic. This situation exposes the limitations of current vaccines that rely on narrowly protective, outdated H5N1 strains, further hampered by slow production processes and stringent cold storage requirements. Our project proposes a groundbreaking shift with the development of a novel pan-H5Nx mRNA vaccine. This vaccine is designed to provide broad-spectrum protection against all circulating H5 clades, incorporate rapid production capabilities, and thermostability at 2-8°C. We are also exploring needle-free delivery, which could revolutionise administration methods. **Innovation in Antigen Design and Production**: Preliminary data suggests our approach is poised to offer comprehensive protection against all circulating H5 clades, making it the only known pan-H5Nx vaccine candidate. This represents a significant enhancement over all existing vaccines. We will develop this preliminary product to set new benchmarks in vaccine efficacy with refined antigenic compositions that induce broad neutralising antibodies and recruit enhanced T-cell responses. **Rapid and Cost-Effective Manufacturing**: mRNA vaccines are more cost-effective at scale and can be manufactured up to 2.5x faster than traditional vaccines, enhancing the ability to respond to large-scale emerging outbreaks. This 'cell-free' and 'egg-free' manufacturing technology addresses a critical barrier in pandemic preparedness and enables a more agile response to global health threats. **Thermostable and Innovative Delivery**: Our partner ACM Biolabs' thermostable R&D formulation will drastically reduce reliance on cold-chain logistics, and will further enhance cell-mediated immunity. Thermostability at 2-8°C simplifies stockpiling storage and distribution and is particularly crucial for remote areas. Furthermore, we are investigating a nebulisable delivery method, aiming to introduce the first needle-free administration for pandemic flu preparedness. This method seeks to increase uptake, ease administration, and potentially enhance local immune responses by targeting mucosal surfaces. **Expected Outcomes and Impact**: Our project is poised to deliver an optimised mRNA vaccine candidate that protects against all circulating H5 clades, with a thermostable formulation for global distribution, and presents preliminary data on a potentially transformative nebulisable delivery system. Our initiative leverages the expertise of a multidisciplinary team specialising in virology, immunology, clinical development, and trial expertise, collaborating with ACM Biolabs to enhance our response to pandemic threats and transform the paradigm of global pandemic preparedness.