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GSK gets FDA OK for four-strain flu vaccine
December 17th, 2012
LONDON – GlaxoSmithKline has received Food and Drug Administration approval for Fluarix Quadrivalent, a four-strain seasonal flu vaccine.
GSK said Monday that Fluarix Quadrivalent, for adults and children age 3 and older, represents the first intramuscular vaccine to cover against four influenza strains. The company added that Fluarix Quadrivalent currently isn't approved or licensed in any country outside of the United States.
Scientists classify the flu strains that cause seasonal flu as A or B strains. The currently administered trivalent (three-strain) flu vaccines help protect against the two A virus strains most common in humans and the B strain expected to be predominant in a given year.
But since the year 2000, two B virus strains (Victoria and Yamagata) have co-circulated to varying degrees each season, according to GSK Various degrees of mismatch have occurred between the B strain included in trivalent vaccines and the B strain that actually circulated, causing an increased risk of flu-related morbidity across all age groups — children, adults and the elderly.
Fluarix Quadrivalent helps protect against the two A strains and adds coverage against a second B strain, GSK said.
"Trivalent influenza 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," stated Dr. Leonard Friedland, vice president and head of GSK North America Vaccines Clinical Development and Medical Affairs. "Fluarix Quadrivalent will help protect individuals against both B strains and, from a public-health standpoint, can help decrease the burden of disease."
GSK said it plans to make Fluarix Quadrivalent available in time for the 2013-14 flu season and to fulfill orders for its trivalent vaccines. Health care providers typically order flu vaccines about a year in advance of each flu season.