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FDA OKs new type of flu vaccine


By Paul Barr
Posted: November 21, 2012 - 12:15 pm ET
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The Food and Drug Administration announced it has approved a new seasonal influenza vaccine that is produced using cultured animal cells, a method that makes it easier to keep supplies readily available and is quicker to produce in the event of a pandemic than current methods used in the U.S.

The vaccine, called Flucelvax, is approved for use to prevent seasonal flu in people 18 and older and is produced by Novartis Vaccines and Diagnostics, Marburg, Germany. HHS had announced it was working with Novartis on producing a cell-based vaccine in December of last year. Current U.S. flu vaccines are produced using fertilized chicken eggs, according to the FDA. Cell-based technology is in use for other U.S.-approved vaccines but this is the first approval for a seasonal flu vaccine, according to an FDA news release.

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“The cell-based vaccine is as safe and effective as traditional egg-based vaccine, and the technology used to manufacture it is more flexible and reliable than the traditional technology,” HHS Secretary Kathleen Sebelius said in a statement. “In the event of an influenza pandemic, this cell-based technology could provide a more rapid startup of the vaccine manufacturing process, potentially increasing our nation's health security,” Sebelius said.


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