FDA has approved GlaxoSmithKline’s (GSK) seasonal influenza vaccine, Fluarix, for use in children between three to 17 years. Previously, this vaccine, which contains inactivated influenza A and B viruses, had been sanctioned for those 18 years and older. The agency says that Fluarix proved to be as effective as sanofi pasteur’s Fluzone, which is already approved for use in children ages six months and older.
The safety and effectiveness of Fluarix for use in children ages three years and older was documented by a U.S. study comparing 2,115 children who received Fluarix with 1,210 children who were given Fluzone. Results showed that both groups of children produced similar amounts of antibodies in the blood at levels considered likely to protect against seasonal influenza.
With today’s approval, there are now four companies approved by the FDA to manufacture seasonal influenza vaccine for use in children. In total, five firms have been given the go-ahead to produce vaccines for adults: CSL (Afluria), ID Biomedical (FluLaval), GSK, Novartis (Fluvirin), and sanofi pasteur.