An influenza pandemic remains a major public health concern. A key strategy to prevent a\npandemic is to stockpile and pre-position stable influenza vaccine to allow rapid deployment\nin response to an outbreak. However, most influenza vaccines today are formulated\nas liquids that are stable only within a temperature range of 2Ã?Å¡C to 8Ã?Å¡C and require use of a\ncold chain, making vaccine transportation, distribution, and storage complicated and\nexpensive, particularly for developing countries. To support the National Strategy for Pandemic\nInfluenza preparedness in the United States and internationally, we developed two\nlead dry formulations of stable H1N1 influenza subunit vaccines using freeze-drying technology.\nThe stable formulations contain an excipient combination of a disaccharide, such\nas sucrose or trehalose, and glycine, in addition to a surfactant and phosphate buffer. The\nfreeze-dried vaccines were shown to be safe and remained immunogenic in an in vivo\nstudy in mice. Moreover, the lead formulations demonstrated no significant loss of activity\nafter 40 months at storage temperatures of 25Ã?Å¡C and 37Ã?Å¡C. This stability can be particularly\nattractive as it could eliminate the need to use a cold chain for vaccine deployment and\nfacilitate integration of vaccine distribution with general drug distribution where appropriate.\nThese freeze-dried thermostable influenza subunit vaccines could also reduce the frequency\nof vaccine stockpile turnover, offering a cost-effective option for pandemic\npreparedness.
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