Biotherapies Obtains FDA Licensure for Use of Its Thimerosal-Free H1N1 2009 Monovalent Vaccine in Children

Thu, 11/12/2009 - 3:41am
CSL Biotherapies, a subsidiary of CSL Limited, a leading manufacturers of influenza vaccine, announced that the U.S. Food and Drug Administration (FDA) has approved the company's application for accelerated approval of its seasonal flu vaccine, Afluria(R) (Influenza Virus Vaccine) for use in the pediatric population aged 6 months and older. This approval also included labeling for CSL Biotherapies' Influenza A (H1N1) 2009 Monovalent Vaccine which is an inactivated influenza virus vaccine now indicated for active immunization of persons ages 6 months and older against influenza disease caused by pandemic (H1N1) 2009 virus. This indication is based on the immune response elicited by the seasonal trivalent Influenza Virus Vaccines manufactured by CSL (Afluria(R)). CSL's Influenza A (H1N1) 2009 monovalent vaccine and Afluria are manufactured by the same process. There have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination with Afluria. "The FDA's licensure of CSL Biotherapies' thimerosal-free monovalent pandemic H1N1 vaccine for use in children aged 6 months and older is a critically important milestone," said Paul Perreault, President, CSL Biotherapies. "The U.S. Centers for Disease Control has identified young children as a priority group for pandemic H1N1 vaccine administration. CSL Biotherapies is proud to now be in a position to help in protecting this most vulnerable population of Americans." CSL's pandemic H1N1 vaccine is available in both thimerosal-free (i.e., preservative-free), single-dose, pre-filled syringes and multi-dose vial (thimerosal containing) formulations, as directed by the U.S. government. The thimerosal-free formulation is available in two dosages: -- A 0.25 mL single-dose, pre-filled syringe for use in children 6-35 months of age; -- A 0.5 mL single-dose, pre-filled syringe for use in persons 36 months of age and older

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