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HHS Awards Novartis Vaccine Contract

January 22, 2009
Patricia Van Arnum

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Department of Health and Human Services's Biomedical Advanced Research and Development Authority has awarded Novartis a contract valued up to $486 million over eight years to support the design, construction, validation, and licensing of a US cell-based influenza vaccine manufacturing facility in Holly Springs, North Carolina.

Basel, Switzerland (Jan. 15)-The US Department of Health and Human Services’s (HHS) Biomedical Advanced Research and Development Authority has awarded Novartis a contract valued up to $486 million over eight years to support the design, construction, validation, and licensing of a US cell-based influenza vaccine manufacturing facility in Holly Springs, North Carolina. The award will support the prepandemic supply of influenza vaccine and provide the capacity to manufacture 150 million doses of pandemic vaccine within six months of declaration of an influenza pandemic.

Under the contract, Novartis is responsible for the preconstruction, document development, land use and zoning, construction, commissioning, validation and licensing of the facilities, which are already under construction in Holly Springs, with the goals of regulatory licensure, manufacture and release of seasonal and prepandemic 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 prepandemic vaccine for a minimum of three years. In addition, HHS has the right to exercise options to purchase additional influenza vaccine for 17 years.

“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,” said Andrin Oswald, CEO of Novartis Vaccines and Diagnostics, in a company press release.

Novartis announced plans to build a $600-million cell-culture vaccine manufacturing facility in Holly Springs in 2006, which at the time included a $220-million award from HHS.