PHILADELPHIA — GlaxoSmithKline has received approval from the Food and Drug Administration’s Center for Biologics Evaluation and Research expanding the indication for FluLaval Quadrivalent flu vaccine to include use in children ages 6 months and older.
GSK said that previously FluLaval Quadrivalent was only cleared for active immunization against influenza A subtype viruses and type B viruses in children ages 3 years and older.
Before the approval of the expanded age indication for FluLaval Quadrivalent, health providers who preferred prefilled syringes had to order and stock two separate flu vaccines to be able to immunize all patients. With the FDA clearance, providers can now use the same dose of FluLava Quadrivalent (15ug of hemagglutinin per virus strain in 0.5 ml) to vaccinate all recommended patients ages 6 months and older, according to GSK.
“The flu is a serious disease with a significant impact on public health and can lead to thousands of deaths in the US every flu season,” stated Patrick Desbiens, senior vice president of U.S. vaccines at GSK. “Children are particularly at risk from complications associated with flu, and vaccination is the best way parents can help protect them against this serious illness. This expanded indication builds upon GSK’s commitment to influenza vaccines and its legacy as the first manufacturer to bring quadrivalent (four-strain) flu vaccines to the U.S. market.”