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FDA approves GSK's four-strain Flulaval vaccine

Drug maker approved to distribute four-strain Fluarix earlier this month

LONDON — The Food and Drug Administration has approved a vaccine made by GlaxoSmithKline that protects against four strains of the flu, the drug maker said.

GSK announced the approval of Flulaval Quadrivalent (influenza virus vaccine) in patients aged 3 years and older for protecting against two strains of the A and B strains of the virus; quadrivalent refers to the four strains the vaccines protect against, as opposed to three-strain trivalent vaccines. The FDA also approved GSK's Fluarix Quadrivalent in December 2012, and the company received FDA approval for shipment of that vaccine earlier this month.

"Since the late 1980s, public health authorities have known that four primary influenza strains circulate each year, causing the majority of influenza illness, but the influenza vaccines used for the past 30 years only covered against three strains," GSK Vaccines North America director of scientific affairs and public health Leonard Friedland said. "With this limitation, global influenza experts have had to make a difficult determination around the strains each season to cover, and in six of the past 11 influenza seasons, one of the predominant strains was not included in the season's influenza vaccines."


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