Novartis announced today that it has been awarded a contract valued at USD 40.95 million to supply to the US government a pre-pandemic influenza vaccine* against the H5N1 avian influenza strain. Global health authorities have identified H5N1 as an influenza strain with pandemic potential.
The pre-pandemic vaccine ordered by the US Department of Health and Human Services (HHS) will contribute to the US National Strategic Stockpile, which is being built in accordance with the US Pandemic Preparedness Plan. The current plan calls for availability of enough avian influenza vaccine to immunize a 20 million-member critical workforce prior to and at the onset of an influenza pandemic This contract follows a USD 62.5 million award from the US government that was announced in October 2005.
“Novartis is pleased to have been chosen to support the US government in its proactive approach to ensuring protection against the impact of a potential pandemic. At Novartis, we have the knowledge, skills and commitment in research and development as well as manufacturing to be a long-term partner in pandemic preparedness,” said J?rg Reinhardt, CEO of Novartis Vaccines and Diagnostics. “We will continue working with governments around the world to proactively help address this public health concern.”
The US government will determine the dosage and formulation of the final product, including potentially adding an adjuvant such as MF59, at a later date. Studies have shown that the proprietary adjuvant MF59 of Novartis could boost the protective effect of an avian influenza vaccine, thereby reducing the required dose and possibly providing protection against other potential strains of avian flu virus.
Novartis will manufacture the pre-pandemic egg-based vaccine in 2007 at its facility in Liverpool, England, following the production of Fluvirin? influenza virus vaccine for the 2007-2008 influenza season. The vaccine will be based on an inactivated H5N1 influenza strain.
Novartis is also manufacturing H5N1 influenza vaccine at its other European facilities for stockpiling efforts of other countries. Earlier this year, Novartis submitted a “mock-up” file for pandemic influenza vaccine containing its MF59 adjuvant to the European Medicines Agency (EMEA). The mock-up file lays the groundwork for a potentially more rapid approval of a vaccine once a pandemic occurs.
In addition, Novartis announced in May 2006 that the US government had awarded Novartis up to USD 220 million to support the development and manufacturing of a cell culture-derived influenza vaccine, both to supply seasonal influenza vaccine and to respond rapidly in the event of an influenza pandemic. Part of this grant will support the planning and construction of a new cell culture-derived influenza vaccines manufacturing plant at a site in Holly Springs, North Carolina.
About pandemic influenza
Pandemic influenza occurs when a new virus emerges that is easily transmitted among humans and causes serious illness. In this situation, the virus can result in a worldwide outbreak of disease, or pandemic. Pandemic influenza occurred three times in the last century; the 1918 outbreak killed at least 40 million people, with a mortality rate of approximately 2.5 percent in the United States.
Avian influenza, or “bird flu,” does not normally infect humans, but there have been several examples in recent years of transmission to people, leading to fears of a strain with the potential to result in a pandemic. The current outbreak of H5N1 avian influenza has resulted in more than 250 laboratory-confirmed human cases since 2003, with cases in Azerbaijan, Cambodia, China, Djibouti, Egypt, Indonesia, Iraq, Thailand Turkey and Vietnam. The associated mortality rate has exceeded 50 percent. The World Health Organization (WHO) classifies the current global situation as a level 3 pandemic alert (on a 1-6 scale where 6 is pandemic).
* The stockpile vaccine is for government supply and is not approved for general sale.