Novartis announced that the US Department of Health and Human Services, Biomedical Advanced Research and Development Authority (HHS, BARDA) has awarded Novartis Vaccines a contract for up to USD 486 million over eight years to support the design, construction, validation, and licensing of US cell-based influenza vaccine manufacturing facilities in Holly Springs, North Carolina, to provide a pre-pandemic supply of influenza vaccine and to provide the capacity to manufacture 150 million doses of pandemic vaccine within six months of declaration of an influenza pandemic.
"I am delighted that Novartis Vaccines' facilities in Holly Springs will be able to support the US Government's ability to respond quickly to a potential pandemic, as well as contribute to America's vaccine infrastructure for seasonal flu," said Dr. Joerg Reinhardt, chief operating officer of Novartis. "We believe that this contract award underscores the US Government's commitment to ensure pandemic vaccine supply, and reflects their confidence in Novartis."
A major advantage of Holly Springs' future influenza cell culture production is that it will not rely on the availability of eggs. Avian influenza virus is currently considered the most likely source of the next pandemic – and it is lethal to both chickens and their eggs. Without eggs, traditional influenza manufacturing techniques cannot produce vaccines, so the Holly Springs flu cell culture production capabilities would be a vital alternative.
"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," added Dr. Andrin Oswald, 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, pre-pandemic vaccine and 150 million doses of pandemic vaccine within six months of the declaration of an influenza pandemic."
Under the contract, Novartis is responsible for, among other things, pre-construction document development, land use and zoning, construction, commissioning, validation and licensing of the facilities (which are already under construction in Holly Springs, North Carolina), with the goals of regulatory licensure, manufacture and release of seasonal and pre-pandemic vaccine, as well as provision for pandemic vaccine supply in the event of a pandemic. The contract also requires Novartis to provide two commercial-scale annual lots of pre-pandemic vaccine for a minimum of three years. In addition, HHS has the right to exercise options to purchase additional influenza vaccine over 17 years.