FluLaval Quadrivalent Receives Expanded Indication

Officials with GlaxoSmithKline have received approval from the FDA’s Center for Biologics Evaluation and Research to expand the indication for FluLaval Quadrivalent to include use in children aged 6 months and older.

Officials with GlaxoSmithKline have received approval from the FDA’s Center for Biologics Evaluation and Research to expand the indication for FluLaval Quadrivalent to include use in children aged 6 months and older. FluLaval Quadrivalent is an influenza vaccine that was previously approved for active immunization against influenza A subtype viruses and type B viruses in children aged 3 years and older and adults.

The new expanded indication approval will also allow providers to use 15 μg of hemagglutinin per virus strain in 0.5-mL doses to vaccinate all recommended individuals aged 6 months and older. Previously, providers who preferred prefilled syringes had to order and stock 2 separate influenza vaccines in order to immunize all patients.

“The flu is a serious disease with a significant impact on public health and can lead to thousands of deaths in the United States every flu season,” Patrick Desbiens, GlaxoSmithKline’s US Vaccines Senior Vice President, said in a press release. “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.”

The approval was based on one phase 3 study and 3 supportive clinical studies conducted in children aged 6 months through 35 months.