Flu Vaccine: Age Indication Approved

The FDA has approved the expansion of the age indication for FluLaval Quadrivalent to include children aged 6 months and older. Before the expansion, the vaccine for active immunization against influenza A subtype viruses and type B viruses was limited to children 3 years of age and older.

The new indication should ease vaccine preparation practices for health care providers. Prior to the new approval, clinicians who wanted to use prefilled syringes needed to order and stock two separate influenza vaccines in order to reach all patients. Now, the same 15 μg of hemagglutinin per virus strain in 0.5 mL dose of the quadrivalent vaccine is available for all patients aged 6 months and older.

The change in age recommendation was based on a Phase III study and three supportive studies that examined children aged 6 months through 35 months.

“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,” said Patrick Desbiens, Senior Vice President, at GlaxoSmithKline, the company that produces the vaccine.

—Lauren LeBano


GSK Receives FDA Approval for Expanded Indication for FluLaval Quadrivalent (Influenza Vaccine) for Infants 6 Months and Older. Press Release. 18 Nov 2016.