The FDA has approved the use of CSL Biotherapies’ 2009 H1N1 monovalent influenza vaccine for use in infants and children ≥6 months of age. The expanded approval also covers CSL’s seasonal influenza vaccine Afluria (trivalent, inactivated, “split virus” influenza vaccine [Types A and B]). The approval was based on study data in children showing the vaccine’s safety and efficacy in inducing antibodies to protect against influenza. These efficacy findings supported approval under FDA’s accelerated approval regulation.

CSL’s 2009 H1N1 influenza vaccine and Afluria are already approved for use in adults ≥18 years of age.

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