FDA approval expands use of FluLaval influenza vaccine

GlaxoSmithKline announced its FluLaval Quadrivalent influenza vaccine has been approved by the FDA for use in children aged 6 months and older.

Previously, the vaccine was only approved for use in influenza A subtype viruses and type B viruses in those aged 3 years and older.

“The flu is a serious disease with a significant impact on public health and can lead to thousands of deaths in the U.S. every flu season," Patrick Desbiens, senior vice president, U.S. Vaccines, GlaxoSmithKline, 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.”

According to the company, clinicians no longer have to order and keep two separate influenza vaccines for patients on hand — the same FluLaval vaccination can be used for all recommended patients more than 6 months old. A single dose consists of 15 µg of hemagglutinin per virus strain in 0.5 mL.

The FDA approval came after three supportive clinical studies and one phase 3 pivotal study in children aged between 6 and 35 months, according to the release.

Reference: http://us.gsk.com/en-us/media/press-releases/2016/gsk-receives-fda-approval-for-expanded-indication-for-flulaval-quadrivalent-influenza-vaccine-for-infants-6-months-and-older/

Disclosure: Desbiens is employed by GlaxoSmithKline.