Novartis gets go-ahead for flu vaccine facility
The US Department of Health and Human Services (HHS) has awarded Novartis a $486m (Euro 367m) contract over eight years to build a manufacturing facility for pandemic flu vaccine.
The US Department of Health and Human Services (HHS) has awarded Novartis a $486m (Euro 367m) contract over eight years to build a manufacturing facility for pandemic flu vaccine.
The site in Holly Springs, North Carolina will have the capacity to provide 150 million doses of pandemic vaccine within six months of declaration of influenza pandemic.
Novartis said its novel cell-based manufacturing technology is a vital alternative to traditional egg-based vaccines production.
Commercial production of pre-pandemic and seasonal flu vaccines is planned to start after completion in 2012.
The plant will initially provide 300 highly skilled jobs.
"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.
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 a 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.