FDA Approves Expanded Indication for Quadrivalent Influenza Vaccine

The US Food and Drug Administration’s Center for Biologics Evaluation and Research has approved expanding the indication for GlaxoSmithKline’s Fluarix Quadrivalent (influenza vaccine) to include use in those aged 6 months and older.

First approved in 2012, Fluarix Quadrivalent covers 4 strains of influenza—two strains of influenza A and 2 strains of influenza B. The safety profile for the vaccine is comparable to trivalent influenza vaccines, according to GlaxoSmithKline. Before the expanded indication, the vaccine was only approved for use in those aged 3 years and older.

“The flu vaccine is the one vaccine that people of almost all ages — from 6-month old infants to older adults — should receive annually,” Patrick Desbiens, senior vice president, US Vaccines, said in a statement. “We can now offer 2 flu vaccines that enable providers to use the same vaccine dose to help protect all recommended persons aged 6 months and older against this potentially serious illness.”

The supplemental biologics license application, submitted in March 2017, was based on a phase 3 pivotal study of the efficacy of the vaccine in children between the ages of 6 and 35 months, as well as 2 supportive studies.

The most common solicited adverse effect reaction in adults was pain, while the most common systemic adverse effects in adults were muscle aches, headaches, and fatigue.

In children aged 6 through 35 months, the most common solicited adverse effects were pain and redness; the most common systemic adverse reactions were irritability, loss of appetite, and drowsiness.

Common solicited adverse effects in children 3—17 years of age included pain, redness, and swelling. In those 3–5 years of age, the most common systemic adverse effects included drowsiness, irritability, and loss of appetite.

Children aged 6—17 years old reported fatigue, muscle aches, headache, arthralgia and gastrointestinal symptoms as the most common systemic adverse effects.