Novartis receives US government contract to further develop novel antigen technology

Swiss company Novartis has received a contract from the US Department of Health and Human Services (HHS) worth US$55m to support its efforts to bring the antigen-sparing capabilities of the MF59 adjuvant to the US.

This latest HHS contract supports development efforts in the US to evaluate the safety and effectiveness of the MF-59 adjuvant in a cell culture based pandemic influenza vaccine. The award will also support the design, equipment and validation for a US-based MF59 production facility in Holly Springs, North Carolina.

In May 2006, Novartis received a contract from the HHS to develop a cell culture based influenza vaccine and to develop and design a manufacturing facility for such a vaccine in the US. Separately, in October 2005 and November 2006 Novartis was awarded contracts for a pre-pandemic vaccine by the HHS to contribute to the US National Strategic Stockpile, which is being built in accordance with the US Pandemic Preparedness Plan.

While normal seasonal influenza vaccines use 15µg of antigen per influenza strain in each single dose of trivalent vaccine, current clinical data show that similar H5N1 pandemic vaccines may require up to 90µg of antigen per dose, with two doses necessary to achieve the desired immunogenicity in people. However, several studies have found that the addition of the MF59 adjuvant from Novartis may reduce the amount of antigen necessary. In addition, the adjuvant holds the potential to provide cross-protection against drifted strains of an avian influenza virus.

'The use of our proprietary adjuvant MF59 with influenza vaccines has shown to be dose sparing and to provide additional immunogenicity against a broader range of potential pandemic influenza strains, while using lower amounts of viral antigen for the vaccine,' said Dr Joerg Reinhardt, ceo of Novartis Vaccines and Diagnostics.