-- Scott Roberts
THURSDAY, Jan. 17 (HealthDay News) -- Flublock, a new vaccine
that uses recombinant DNA technology to prevent the flu, has been
approved by the U.S. Food and Drug Administration for people aged
18 to 49.
Flublock doesn't use traditional flu vaccine components --
including the influenza virus or eggs -- in its production.
Instead, it uses an insect virus (baculovirus) to produce large
amounts of the influenza virus protein, hemagglutinin (HA). Most
antibodies that prevent flu infection are directed against HA, the
FDA explained in a news release.
"This approval represents a technological advance in the manufacturing of an influenza vaccine," Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, said in the news release. "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."
The vaccine can be modified before each flu season to include
the most predominant flu strains, the agency said.
The product's effectiveness was evaluated in a study that
compared use of Flublok in about 2,300 people to a control group of
a similar size that was given a placebo. The vaccine was about 44.6
percent effective in preventing infection with all circulating
strains of flu, not just those included in the vaccine, the FDA
The most common side effects noted were injection-site pain,
headache, fatigue and muscle aches -- typical adverse reactions
among conventional flu vaccines.
Flublok is produced by Protein Sciences Corp., based in Meridan,
The FDA has more about
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