Company wins US approval for new flu vaccine
{{#rendered}} {{/rendered}}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.
{{#rendered}} {{/rendered}}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.
{{#rendered}} {{/rendered}}"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 flu season.
Fluarix Quadrivalent is not currently approved or licensed in any country outside of the United States.