Current influenza vaccines use liquid formulations that have a limited shelf life, require refrigerated storage and, with the exception of AstraZeneca’s FluMist, are delivered by injection.
FluMist is the only FDA approved nasal flu vaccine – AstraZeneca obtained the product through its $15.6 billion purchase of MedImmune. The company anticipates higher
Irving, TX-based DelSite Biotechnologies, a subsidiary of Carrington Laboratories, is developing a nasally administered vaccine the can be stored and shipped at room temperature, potentially challenging AstraZeneca’s market dominance.
DelSite’s powder vaccine require no refrigerated shipping or storage: FluMist uses a live vaccine antigen in a liquid formulation while DelSite uses an inactivated vaccine antigen.
Improper refrigeration is the single biggest cause of waste in the $2-billion-a-year federal Vaccines for Children Program, according to Lance Rodewald, director of the Immunization Services division at the CDC.
These attributes also make DelSite’s vaccine well suited to “pandemic preparedness” – when such products may need to be stockpiled for extended periods of time and rapidly distributed and self-administered under emergency conditions.
The composition of DelSite-enhanced vaccines may boost immunostimulation and potentially enable lower dosing. The high molecular weight ionic polysaccharide found in DelSite’s vaccine cause the dry powder to change into gel particles upon contact with liquid in the nasal cavity. The in-situ gel provides sustained antigen release and prolonged nasal residence.
DelSite is expected to enter human clinical trials to study the product’s effectiveness against flu early next year.
The top five vaccine companies’ worldwide: GSK Biologicals, Sanofi-Pasteur, Merck, Wyeth and Novartis collectively sold $11 billion worth of vaccines in 2006, this number is expected to grow to $17 billion by the end of 2007, according to VacZine Analytics, a strategic research firm based in the U.K.