CSL Biotherapies, a subsidiary of CSL Limited, one of the world's leading manufacturers of influenza vaccine, announced that the US Food and Drug Administration (FDA) has approved the company's application for accelerated approval of its seasonal flu vaccine, Afluria (Influenza Virus Vaccine) for use in the paediatric population aged six months and older. This approval also included labelling for CSL Biotherapies' Influenza A (H1N1) 2009 Monovalent Vaccine which is an inactivated influenza virus vaccine now indicated for active immunization of persons ages six 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). 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 six months and older is a critically important milestone," said Paul Perreault, president, CSL Biotherapies. "The US 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; and A 0.5 mL single-dose, pre-filled syringe for use in persons 36 months of age and older
CSL Biotherapies has an initial contract worth US$ 180 million to deliver bulk H1N1 vaccine antigen to the US Health and Human Services Department (HHS), with an option for filling and packaging services out of CSL's Kankakee, Illinois and Marburg, Germany facilities.