GSK's Flulaval vaccine approved by US FDA

UK pharma giant GlaxoSmithKline (LSE: GSK) has had its Flulaval quadrivalent intramuscular influenza vaccine approved by the US Food and Drug Administration.

It has been approved for the active immunization of persons three years of age and older to help prevent disease caused by seasonal influenza (flu) virus subtypes A and B contained in the vaccine. This is the second GSK intramuscular quadrivalent influenza vaccine approved by the FDA after Fluarix was the first-ever intramuscular influenza vaccine approved by the FDA in December 2012 ( The Pharma Letter December 17 2012).

Leonard Friedland, director of scientific affairs and public health, GSK Vaccines North America, said:  “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. 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 (2001-2012), one of the predominant strains was not included in the season's influenza vaccines. Trivalent vaccines do reduce influenza risk even in years when a vaccine strain-mismatch occurs, though quadrivalent influenza vaccines are the important next step in broadening strain coverage."