Chiron initiates Phase I/II study of an investigational cell culture-derived influenza vaccine

Chiron Corporation has announced that it has initiated a Phase I/II study of an investigational cell culture-derived influenza vaccine in the United States. Cell culture-derived influenza vaccine (commonly referred to as "flu cell culture" vaccine) represents the next generation of influenza vaccine, both for annual vaccine production and for long-term pandemic preparedness.

Production of influenza vaccine using cell-culture technology may offer significant advantages over traditional manufacturing methods by eliminating the dependence on chicken eggs for production. The removal of egg supply lead times would enable flexible and faster start-up of vaccine production in the event of an annual vaccine supply shortfall or an avian influenza pandemic.

The company has also completed enrollment of a second Phase III study of investigational flu cell culture vaccine in Europe. A first pivotal Phase III study of flu cell culture vaccine in Europe, conducted in 2004, met the safety and immunogenicity endpoints of the study.

"Chiron is an industry leader in developing flu cell culture, and we are committed to supporting public health authorities globally by working to make this next-generation vaccine available, both for prevention of annual influenza and as an important platform for pandemic preparedness," said Dan Soland, president of Chiron Vaccines. "In addition to our return of FLUVIRIN(R) influenza virus vaccine to the U.S. annual influenza vaccine market, Chiron has several programs underway to enhance our capability to help protect people from the threat of influenza. Flu cell culture, along with our research on avian pandemic influenza vaccines and adjuvants, could contribute to a flexible and cutting-edge infrastructure to meet current and future influenza threats and help save lives."

Chiron's flu cell culture vaccine is produced from virus propagated in the Madin-Darby Canine Kidney (MDCK) cell line. The company filed an investigational new drug application (IND) for flu cell culture vaccine in the United States last year, after regaining its U.S. rights to the technology. The investigational vaccine is produced at Chiron's state-of-the-art flu cell culture vaccine manufacturing facility in Marburg, Germany.

"Moving from egg-based to cell-based influenza vaccine production is an important step in enhancing our preparedness against pandemic influenza and provides flexibility in meeting surges in influenza vaccine demand," said Walter A. Orenstein, M.D., professor of medicine of pediatrics and associate director of the Emory Vaccine Center in Atlanta, Georgia. "This effort will help address the challenge of responding to a pandemic."

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