FDA approves Flucelvax – first licensed cell-culture influenza vaccine

   The FDA said it approved Flucelvax, described as 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. Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research, said, “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.” Flucelvax is manufactured by Novartis Vaccines and Diagnostics GmbH, Marburg, Germany.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm328982.htm