Nov 20 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
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
In clinical trials, Flucelvax was 83.8 percent effective in
preventing flu when compared with a placebo.