STTR Phase I: Room Temperature Stable, Dry Powder Particle-Based Vaccines Against Influenza

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project is to demonstrate room-temperature-stable, dry powder inhalable influenza vaccines represent as an innovative, next generation technology to promote the health and welfare of the American public by eliminating the existing pain points of current influenza vaccines. The global influenza vaccine market size is projected to increase to $17.77 billion by 2032. Therefore, the demand for innovative vaccines against seasonal respiratory viruses remains a high priority. These dry powder vaccines introduce a transformative innovation – induction of durable protective immunity that targets both the upper and lower airways via nasal delivery and removing the cold chain due to room-temperature shelf stability, thereby lowering vaccine costs and wastage. This outcome can result in cost savings of up to 80%. The economic and social benefits of this vaccine technology will lead to achieving and maintaining a significant market share of the flu vaccine market. Additionally, this technology’s plug-and-play capability allows swapping pathogen-specific proteins and creating new inhalable room-temperature-stable vaccines for other respiratory pathogens. Altogether, this advance will significantly lower storage costs while improving our nation’s strategic preparedness in stockpiling vaccines against circulating disease, emerging threats, or biowarfare agents. This Small Business Technology Transfer (STTR) Phase I project will demonstrate the feasibility of producing a novel room-temperature-stable, dry-powder inhalable influenza vaccine and using a new scalable process to manufacture the vaccine. Current flu shots do not provide lung-specific immune responses and require refrigerated storage. This project’s value proposition is to replace current needle-in-the-arm, partially effective flu shots with next-generation vaccines and delivery methods. This project enables the risk-reducing R&D needed to advance a dry powder vaccine manufacturing technology called Payload Reduction and Encapsulation Technology (PRET). The goal is to demonstrate feasibility of this manufacturing method by showing dry powder influenza vaccines synthesized by PRET result in reproducible dry powder vaccine characteristics, high vaccine yields, protection against influenza infection, and room-temperature shelf stability. There are three objectives that will be pursued to demonstrate this: 1) feasibility of achieving initial pilot-scale production and characterization of dry powder influenza vaccines using PRET; 2) dry powder influenza vaccine efficacy compared to traditional flu vaccines; and 3) production of influenza particle-based vaccines using scaled-up engineering runs and evaluation of room-temperature shelf-life. The new paradigm represented by room-temperature-stable, dry powder vaccines has the potential to transform the vaccine-delivery landscape and enhance the nation’s pandemic preparedness. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.