Novartis Gains FDA Approval for Seasonal Influenza Vaccine Flucelvax
Published Date :
Nov 21, 2012
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- Written by Brad Tebbets, Ph.D., GlobalData's analyst covering infectious diseases.

On Tuesday, the FDA announced that it had approved Novartis’ cell culture–based seasonal influenza vaccine, Flucelvax. The vaccine is approved for use in adults 18 years of age and older. Flucelvax will be the first seasonal influenza vaccine available in the United States to use cell culture instead of the standard manufacturing process using chicken eggs.

The propagation of influenza virus in chicken eggs has been the standard in the influenza vaccine manufacturing process for decades. Unfortunately, this process takes months, and the egg-based process is difficult to scale-up. However, Producing influenza vaccines via cell culture–based technology requires less manufacturing time and is more amenable to increasing the production scale.

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