* First U.S. approved flu vaccine using animal cell cultures
* Process is faster than growing virus in chicken eggs
* Novartis will produce vaccine in new North Carolina plant
Nov 20 The U.S. Food and Drug Administration
said on Tuesday it approved a seasonal flu vaccine produced by
Novartis using animal cell culture rather than the
traditional manufacturing using chicken eggs - a speedier
process that could help build stockpiles in the event of a
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 cell cultures derived 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 health crisis, such as a flu pandemic. Traditional
flu vaccine production requires a tremendous number of
fertilized chicken eggs to grow virus strains and often takes
several months before it is ready to be delivered to physicians
The cell-based process also enables manufacturers to
maintain a supply of readily available, previously tested cells
for use in vaccine production.
"Modern cell-culture technology will likely become the new
standard for influenza vaccine production," predicted Andrin
Oswald, head of Novartis' vaccines and diagnostics division.
Flucelvax will eventually be manufactured at a new U.S.
plant in Holly Springs, North Carolina, once that facility is
ready for full-scale commercial production, Novartis said.
The production takes place in a sterile, controlled
environment, which significantly reduces the risk of potential
impurities, the company said.
In clinical trials, Flucelvax was 83.8 percent effective in
preventing flu when compared with a placebo.
A limited supply of the new vaccine will be available for
this year's flu season, Novartis spokeswoman Liz Power said.
Novartis supplies the United States with about 30 million
doses of flu vaccine annually, she said.