Jan 16 (Reuters) - The U.S. Food and Drug Administration on
Wednesday approved the first influenza vaccine made using
recombinant DNA technology, rather than live flu virus.
Flublok, made by Protein Sciences Corp, was approved for the
prevention of seasonal influenza in people 18 through 49 years
of age, the regulatory agency said. FDA said that unlike current
vaccines Flublok does not use the influenza virus or eggs in its
production.
Recombinant DNA technology allows the genetic material to be
produced artificially by joining different strands of DNA in the
laboratory.
"This approval represents a technological advance in the
manufacturing of an influenza vaccine," Karen Midthun, director
of the FDA's Center for Biologics Evaluation and Research, said
in a statement. "The new technology offers the potential for
faster start-up of the vaccine manufacturing process in the
event of a pandemic, because it is not dependent on an egg
supply or on availability of the influenza virus."
Flublok's manufacturing technology allows for production of
large quantities of the influenza virus protein, hemagglutinin -
the active ingredient in all inactivated influenza vaccines that
is essential for entry of the virus into cells in the bodies.
As it does with all flu vaccines, the FDA said it will
evaluate Flublok annually prior to use by the public each flu
season.
Flublok was evaluated in a study of about 2,500 people. The
most commonly reported adverse events included pain at the site
of injection, headache, fatigue and muscle aches, which are also
side effects typical for conventional egg-based, inactivated
influenza vaccines.
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