mRNA vaccines can play an important role in rapid response to pandemics and other disease outbreaks. Rapid and equitable access to mRNA vaccines is essential to reduce morbidity and mortality, especially in underserved or hard-to-reach communities, and to reduce the global spread and impact of disease. Cold chain requirements and the need for skilled administration are significant factors in this accessibility divide.
Vaxxas has developed a high-density microarray platform (HD-MAP) that delivers vaccine into the upper skin layers, technology proven in multiple Phase 1 studies to effectively deliver and generate immune responses across a variety of vaccine types at reduced doses and with improved thermostability vs IM (e.g., seasonal influenza, measles rubella, subunit proteins).
We will share recent data demonstrating significantly improved thermostability of mRNA encapsulated in LNP formulations akin to those used in Moderna and Pfizer commercial vaccines, stable for ≥12 months at 2-8°C and 25°C and 3 months at 40°C. Formulation, drying, and product quality approaches will be described, and we will share preclinical data demonstrating in vitro and in vivo protein expression and immune responses, including responses to material stored on HD-MAPs for up to a year.
Based on these foundational data, an mRNA vaccine candidate has been proposed to advance into a Phase 1 clinical program. This platform approach can be applied to other antigens and LNP formulations, supporting CEPI’s “100 days” target and general mRNA vaccine development.