With the flu season months away, GlaxoSmithKline (NYSE:GSK) said Monday it now has Food and Drug Administration approval to start shipping its four-strain flu vaccine Fluarix.
Flurarix is a quadrivalent vaccine; the injectable vaccine provides immunity against two strains each of influenza virus types A and B. The 2013-2014 flu season will be GSK’s first selling a vaccine that protects against more than three strains of flu.
The strains that cause seasonal influenza are classified into two strains, A and B. Most of the current vaccines protect against three strains, two A strains and the B strain expected to be predominant in the coming flu season. But scientists have noted since the late 1980s that two B virus lineage strains circulate to varying degrees from year to year making it difficult to predict which one will be most likely to cause illness.
“Fluarix Quadrivalent addresses this by protecting against both B strains.” Dr. Leonard Friedland, VP, Scientific Affairs and Public Policy, GSK Vaccines, North America, said in a statement.
GSK received FDA approval on Fluarix last year. The latest approval clears the way for GSK to ship Fluarix to those U.S. health care providers who have placed orders for it. The Centers for Disease Control and Prevention has ordered more than 4 million doses of Fluarix making it the largest order of the vaccine. The CDC each each year purchases large quantities of vaccines from various drug companies.
Britain-based GSK, which operates its U.S. headquarters in Research Triangle Park, estimates it will provide as many as 10 million doses of Fluarix in the United States this flu season.
