The facility, which will boost US vaccine production 25 per cent when fully operational in 2012, has been under construction since 2007 when Novartis won its original Department of Health and Human Services (HHS) contract.
The new deal calls for Novartis to develop two new vaccines, for either seasonal or pandemic use. It also provides funding for clinical bridging studies designed to compare the firm’s vaccines to existing products in terms of safety and efficacy, potentially expediting their approval by the US Food and Drug Administration.
As Robin Robinson of the HHS’ Biomedical Advanced Research and Development Authority (BARDA) said, the plant and the flexibility it provides are vital to the country’s pandemic plans.
“In a pandemic we would need vaccine ready within six months,” Robinson explained, adding that this goal could not be accomplished using traditional egg-based manufacturing methods.
Andrin Oswald, CEO of Novartis Vaccines and Diagnostics commented that: "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 150m doses of pandemic vaccine within six months of the declaration of an influenza pandemic."
The ability to freeze cell cultures means that they can be made available for large scale production in a fraction of the time taken to procure the millions of hens eggs needed to make vaccine using the traditional approach, significantly reducing manufacturing lag.
Such flexability and speed means production can be delayed until the specific virus strain responsible for an epidemic, or pandemic, has been properly identified. This avoids the best -guess, blanket approach of combining several likely strains in a vaccine that is necessitated by the longer manufacturing times needed for egg-based production.
Novartis is at the forefront of cell-culture vaccines through its partnership with Dutch firm Crucell and access to the latter’s popular PER.C6 cell line. In 2007, Novartis’ Optaflu, production of which is due to be switched from the firm’s plant in Marburg, Germany to Holly Springs, became the first cell culture-derived vaccine to be cleared by European regulators.
Joerg Reinhardt, Novartis COO said: "We believe that this contract award underscores the US Government's commitment to ensure pandemic vaccine supply, and reflects their confidence in Novartis.”
The announcement of the new contract coincides with the release of a HHS report highlighting “major gaps” in the country’s strategy for coping with the predicted influenza pandemic.
The authors said that although progress has been made, the protection of government workers as a way of maintaining vital infrastructure was not being given sufficient thought, commenting that “even the best plans can fail if managers cannot accommodate significant absenteeism.”