FDA approves novel Novartis seasonal flu vaccine

Tue Nov 20, 2012 5:25pm EST

Nov 20 (Reuters) - The U.S. Food and Drug Administration said on Tuesday it approved a seasonal flu vaccine produced by Novartis using cultured animal cells rather than the traditional manufacturing process that uses fertilized chicken eggs.

The vaccine, to be sold by the Swiss drugmaker under the brand name Flucelvax, is approved to prevent season influenza in people aged 18 and over, the agency said.

To produce Flucelvax, virus strains for the vaccine are grown in animal cells from mammals instead of in chicken eggs. Similar cell culture technology has long been used to produce other types of vaccines, FDA 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," Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, said in a statement.

Using cell cultures rather than chicken eggs allows for a faster start-up of the vaccine manufacturing process in the event of a pandemic. It also enables manufacturers to maintain a supply of readily available, previously tested cells for use in vaccine production.

In clinical trials, Flucelvax was 83.8 percent effective in preventing flu when compared with a placebo.

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