CSL Biotherapies Announces First Shipments of Afluria® Thimerosal-Free Influenza Vaccine for the 2008-2009 Flu Season
Newest U.S. manufacturer on track to deliver more than six million Afluria doses
King of Prussia, PA — 09/04/2008
CSL Biotherapies, a subsidiary of one of the world's leading manufacturers of influenza vaccine, announced today that it has begun shipment of its influenza virus vaccine in the U.S. for the 2008-2009 season. CSL plans to deliver more than six million doses of Afluria and the majority of the supply will be in single-dose, thimerosal-free, pre-filled syringes.
Afluria is indicated for the active immunization of persons age 18 years and older against influenza disease (commonly referred to as the "flu") caused by influenza virus subtypes A and type B present in the vaccine. The indication is based on the immune response elicited by Afluria; no controlled clinical studies have demonstrated a decrease in influenza disease after vaccination with Afluria.
"CSL's delivery of more than six million doses of Afluria influenza vaccine to the U.S. marks a three-fold increase of Afluria vaccine supply to the U.S. over last year, and demonstrates CSL's ongoing commitment to addressing a public health need in the U.S.," said Paul Perreault, Executive Vice President of CSL Biotherapies Worldwide Commercial Operations. "A steady supply of the influenza vaccine in the U.S. is crucial and we're pleased to once again offer our thimerosal-free and latex-free flu vaccine to providers and consumers."
Since receiving approval to market and distribute Afluria in the U.S. in 2007, CSL has made significant contributions to helping improve influenza vaccination rates in the U.S. "CSL's mission is to protect lives through vaccination, so we will continue to support educational and community efforts to increase vaccination rates in priority and at-risk U.S. populations, such as healthcare workers, pregnant women and college students," said Perrault.
Afluria is a purified, inactivated, trivalent influenza vaccine propagated in embryonated chicken eggs. Each dose contains the required dose of influenza virus hemagglutinin antigens from the influenza strains recommended and prioritized by FDA's Vaccine and Related Biological Products Advisory Committee. Previous international flu vaccine studies sponsored by CSL Ltd., and a clinical trial conducted by the NIH, formed the basis for CSL Biotherapies' biologics licensing application submission.
Important Safety Information
Afluria should not be administered to individuals with hypersensitivity to eggs or chicken protein or other components of Afluria, and to anyone who has had a life-threatening reaction to previous influenza vaccination. The most common injection-site adverse reactions were tenderness, pain, redness and swelling. The most common systemic adverse reactions were headache, malaise and muscle aches. Vaccination with Afluria may not protect all individuals. Immunocompromised persons may have a diminished immune response. If Guillain-Barré syndrome has occurred within six weeks of receipt of prior influenza vaccine, the decision to give Afluria should be based on careful consideration of the potential benefits and risks. Full prescribing information on Afluria can be found at www.Afluria.com
About CSL Biotherapies
The U.S. headquarters of CSL Biotherapies are located in King of Prussia, Pa. Its parent company, CSL Limited, in Melbourne, Australia, operates one of the world's largest influenza vaccine facilities for global markets. CSL Biotherapies, which shares its U.S. headquarters with its sister company, CSL Behring, is commercializing influenza vaccine products globally. At CSL Biotherapies, delivering vaccines is our mission, protecting lives our passion. The CSL Group, which also includes CSL Research & Development, CSL Bioplasma, and CSL Behring, has more than 8,500 employees and operates in 21 countries worldwide. For more information, visit us at www.cslbiotherapies-us.com
, or call 1-888-435-8633.
Sheila A. Burke
Director, Public Relations & Communications
Worldwide Commercial Operations
Abenaa (Abby) Hayes