Sanofi Pasteur and MedImmune have signed two separate five-year, cost-reimbursable contracts worth $77.4m and $55.1m respectively. In the face of the pandemic threat that bird flu poses, the US Government is just one of many governments from around the world taking all possible measures to reduce the risk of mass sickness and deaths, should an outbreak occur. The deal also follows last week's announcement by the World Health Organization (WHO) that it plans to create a global stockpiling scheme with millions of doses of an H5N1 vaccine. However, the US contract is not tied down to an H5N1 outbreak, with the manufacture of the flu strain-come-vaccine to be at the government's discretion. "We must prepare for a flu pandemic, although it may not be possible to be certain when the next one will come or how severe it will be," US Department of Health and Human Services (HHS) secretary Mike Leavitt said in a statement. "These contracts are important advances in the path of preparation because they help the nation build its capacity to respond." The Sanofi Pasteur contract involves a retrofit to the existing influenza vaccine manufacturing facility in Swiftwater Pennsylvania, of which Sanofi Pasteur would contribute approximately $25m from its own coffers to the overall project. Likewise, MedImmune would contribute $14m to retrofit its California, Pennsylvania and Kentucky manufacturing facilities to produce pandemic influenza vaccines using its proprietary live, attenuated, needle-free influenza vaccine technology, FluMist. FluMist is the first flu vaccine to be delivered via a nasal spray and is indicated for the prevention of disease caused by influenza A and B viruses.
Both contracts would see the companies upgrading the US facilities to a state of readiness so the companies could switch to pandemic influenza vaccine manufacture at the HHS' request. In the case of an outbreak, the facilities would provide warm-base manufacturing, which involves a constant state of production through annual manufacturing runs. The Sanofi Pasteur upgraded facility would have the ability to provide 150 million doses of its US-licensed egg-based inactivated influenza vaccine. "This award marks the company's seventh pandemic influenza-related contract with the US Government and underscores its commitment to global pandemic preparedness," a Sanofi Pasteur spokeswoman told in-PharmaTechnologist.com. In a statement, MedImmune vice president of government project management Alan Taggart said: "MedImmune is honored to have been chosen once again to collaborate with the federal government to help protect the American public in the event of an outbreak of pandemic influenza." The HHS estimated the expansion of the facilities would increase domestic pandemic vaccine manufacturing capacity by 16 per cent. Additionally, the plants would provide year-round production of pre-pandemic influenza vaccines for the national stockpile, which is currently limited to three months each year. The contract marked Sanofi Pasteur's seventh pandemic influenza-related deal with the US Government. Previous contracts have covered the production of investigational doses for clinical trials; bulk vaccine for stockpiling; the establishment and maintenance of laying chicken flocks to enable year-round egg production; and a contract to speed the production process for new cell culture influenza vaccines, including the design of a US-based cell culture vaccine manufacturing facility.
Meanwhile, this would be MedImmune's second contract and is positive for FluMist which, according to reports, had failed to make significant inroads into the injectable seasonal flu vaccine market, and followed on from MedImmune's acquisition by AstraZeneca earlier this year. The two contracts fall under the HHS Pandemic Preparedness Plan, which was issued in November 2005. Major goals include the establishment of pre-pandemic influenza vaccine stockpiles for 20 million persons in the critical workforce and the expansion of domestic pandemic vaccine manufacturing surge capacity for 300 million people within six months of the onset of an influenza pandemic. Last year, the US Government awarded five contracts to advance cell-based production technology for influenza vaccines as an alternative to egg-based procedures. The recipients were GlaxoSmithKline, MedImmune, Novartis, Solvay and DynPort Vaccine.
The WHO estimates the next influenza pandemic will cause up to 2.3 million hospitalizations and up to 650,000 deaths in industrialized nations alone, with a more devastating impact expected in developing countries.