Novartis has received a contract from the US Department of Health and Human Services (HHS) of approximately USD 55 million.
The contract supports the company's efforts to bring the antigen-sparing capabilities of the MF59 adjuvant to the United States. An adjuvant is a substance added to a vaccine to enhance the body's immune response to the vaccine's active constituent, called the antigen.
"Novartis is committed to the development and supply of vaccines to help protect against both seasonal influenza as well as the possible emergence of pandemic influenza. 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 Jörg Reinhardt, CEO of Novartis Vaccines and Diagnostics.
This latest HHS contract supports development efforts in the US to evaluate the safety and effectiveness of the MF-59 adjuvant in a cell cultured 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 15 micrograms 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 90 micrograms 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 Novartis MF59-adjuvanted seasonal vaccine Fluad was designed to address the poorer antibody response of elderly persons to influenza vaccine, a problem attributed to the general phenomenon of immunosenescence, or aging of the immune system.