The U.S. Department of Health and Human Services, BARDA awarded Novartis a contract totaling $486 million over eight years to design, construct, validate, and license U.S. cell-based influenza vaccine manufacturing facilities in Holly Springs, NC.
The plants will provide a prepandemic supply of vaccines and the capacity to manufacture 150 million doses within six months of declaration of a pandemic. Commercial production of prepandemic and seasonal flu vaccines is planned after completion, which is expected in 2012
A major advantage of Holly Springs' future influenza cell culture production is that it will not rely on the availability of eggs, according to Novartis. Avian influenza virus is currently considered the most likely source of the next pandemic and it is lethal to both chickens and their eggs. So the Holly Springs flu cell culture production capabilities would be a vital alternative.
Under the contract, Novartis is responsible for preconstruction document development, land use and zoning, construction, commissioning, validation, and licensing of the facilities. The contract also requires Novartis to provide two commercial-scale annual lots of prepandemic vaccine for a minimum of three years. In addition, HHS has the right to exercise options to purchase additional influenza vaccines over 17 years.
“This HHS contract builds on the strategic investment made by Novartis in vaccines innovation and reinforces the significant financial and technology investments we have already committed to Holly Springs,” says Andrin Oswald, M.D., CEO of Novartis Vaccines and Diagnostics. “We currently anticipate that by 2012 the site will provide jobs for more than 300 highly skilled people with the capability to produce cell-based seasonal flu vaccine, prepandemic vaccine, and 150 million doses of pandemic vaccine within six months of the declaration of an influenza pandemic.”