Seasonal and Pandemic Influenza
Many currently marketed influenza vaccines are based on a development, production and vaccination strategy that has not changed significantly in the past five decades. Due to the seasonal nature of the disease and the genetic instability of the virus, it is necessary to formulate a new influenza vaccine each year based on an epidemiological prediction of the strains most likely to be circulating in the human population in the next winter’s flu season. Current vaccines aim to elicit an immune response against the hemagglutinin (HA) protein (the component of the virus that serves as a target for a protective immune response). Due to slow development and production cycles, there is general concern that traditional vaccines may not consistently meet the demands of seasonal influenza or potential pandemic virus outbreaks.
VaxInnate’s production of the influenza HA vaccine has proven more efficient and cost-effective than current influenza vaccine production techniques using eggs or cell-culture. In our labs, we grow the necessary proteins in a bacterial expression system, a proven method that is commonly used in the production of other recombinant proteins and biopharmaceuticals.
VaxInnate is working with the U.S. government to meet the demand for influenza vaccines through a contract with BARDA (Biomedical Advanced Research and Development Authority), part of Health and Human Services. VaxInnate’s contract, awarded in February 2011, is valued at up to $196 million over five years, and covers the development of both pandemic and seasonal influenza vaccines. Our active pandemic programs currently focus on H5N1 and H7N9 candidates. Many Phase 1 & 2 clinical trials with monovalent influenza vaccine strains have already been completed and we currently have a safety data base of approximately 1,400 subjects. The seasonal influenza product is a quadrivalent vaccine that has activity against four different strains. The Phase 1 clinical trial for this product began in March 2014. VaxInnate’s technology permits the rapid production of vaccines which could make it possible to address strain changes within an influenza season, in the event of a mismatch.