Novartis receives FDA approval for Flucelvax to prevent seasonal influenza

Published on November 21, 2012 at 2:04 AM · No Comments

The U.S. Food and Drug Administration announced today the approval of Flucelvax, the first seasonal influenza vaccine licensed in the United States produced using cultured animal cells, instead of fertilized chicken eggs. Flucelvax is approved to prevent seasonal influenza in people ages 18 years and older. The manufacturing process for Flucelvax is similar to the egg-based production method, but a significant difference is that the virus strains included in the vaccine are grown in animal cells of mammalian origin instead of in eggs. Cell culture technology has already been in use for several decades to produce other U.S. licensed vaccines

"Today's approval represents the culmination of efforts to develop a seasonal influenza vaccine using cell culture as an alternative to the egg-based process," said Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research. Cell culture technology is another manufacturing alternative to conventional egg-based influenza vaccine production. Advantages of cell culture technology include the ability to maintain an adequate supply of readily available, previously tested and characterized cells for use in vaccine production and the potential for a faster start-up of the vaccine manufacturing process in the event of a pandemic

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