Developing Stable Liquid Pandemic Influenza Vaccines to Improve Shelf Life, Facilitate Distribution, and Increase Pandemic Preparedness

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The 3 human influenza pandemics in the 20th century killed tens of millions of people worldwide. Sporadic human infections by avian H5N1 virus in the past few years have led the scientific community to believe that a virulent virus may emerge as the result of re-assortment between H5N1 virus and seasonal influenza virus, causing another pandemic. There is universal consensus that vaccines are a key tool to prevent and intervene in an influenza pandemic. Pandemic influenza preparedness, as detailed in the Implementation Plan for the National Strategy for Pandemic Influenza, focuses extensively on the establishment of influenza vaccines and on the rapid immunization of citizens. FluGen’s replication deficient M2SR live attenuated vaccine candidate has shown in animal and in vitro models that it has superior properties relative to currently marketed vaccines particularly in the elderly. FluGen’s studies have demonstrated that influenza viruses lacking a portion of their genome replicate well in cell culture but are attenuated in mice and ferrets. This vaccine confers protection against multiple strains of Influenza and can be rapidly produced, due to its cell based production method. The key deliverable of this project is to develop stable liquid formulation of the M2SR vaccine, which is currently stored at -80°C, with critical quality attributes acceptable for use in intranasal products. We will use the replication deficient Flu vaccine for formulation development, which will use FDA approved excipients, using Arestat™ stabilisation technologies. Arestat™ is a proprietary formulation technologyallowing the design of novel liquid formulations of biologics with superior stability. Thetechnology has been validated on a wide range of recombinant proteins and other biologics in collaboration with major pharma companies. The aim is to develop a formulation that allows for storage of the vaccine at 2-8°C with allowances for excursions outside of this temperature range.