Dec 17 U.S. health regulators have approved a
new four-strain seasonal influenza vaccine made by
GlaxoSmithKline Plc, the company said on Monday.
The U.S. Food and Drug Administration has approved Fluarix
Quadrivalent to immunize children age 3 and older and adults
against flu virus subtypes A and B contained in the vaccine.
It is the first intramuscular vaccine to protect against
four influenza strains. Three-strain flu vaccines currently
administered help protect against the two most common A virus
strains and the B strain expected to be predominant in a given
year, the company said.
Since 2000, however, two B virus strains have circulated to
varying degrees each season, meaning patients infected with the
B virus not contained in the vaccine were not immunized.
Fluarix Quadrivalent helps protect against the two A strains
and adds coverage against a second B strain, the company said.
Three-strain vaccines "have helped protect millions of
people against flu, but in six of the last 11 flu seasons, the
predominant circulating influenza B strain was not the strain
that public health authorities selected," said Dr. Leonard
Friedland, head of clinical development and medical affairs for
Glaxo's North American vaccines program.
"Fluarix Quadrivalent will help protect individuals against
both B strains and from a public-health standpoint, can help
decrease the burden of disease."
Glaxo said it will make the vaccine available in time for
the 2013-14 flu season and plans to fulfill orders for its
trivalent, or three-strain, vaccines. Healthcare providers
traditionally order flu vaccines about a year in advance of each
Fluarix Quadrivalent is not currently approved or licensed
in any country outside of the United States.