United States

CSL Biotherapies completes 2013-14 season AFLURIA® shipments

Approximately 11 million doses were delivered;
First US supplier to complete 2013-14 seasonal influenza vaccine shipping

King of Prussia, PA — 09/25/2013

CSL Biotherapies Inc. announced today it has finalized shipment of 11 million doses of AFLURIA®, its seasonal influenza vaccine for the 2013-2014 season. Completion of the 2013-14 shipping campaign will ensure that healthcare providers using AFLURIA® are able to conduct their immunization programs as planned.

“CSL Biotherapies is committed to supporting the needs of healthcare professionals in the United States,” said Dr. Marie Mazur, Head of Worldwide Commercial Operations, Influenza. “Our early and rapid delivery of AFLURIA® for the 2013-14 season attests to this commitment, and, most importantly, helps to ensure that influenza vaccine providers have a high quality influenza vaccine to use in combatting the flu in their communities, a very serious public health concern.”

CSL Biotherapies AFLURIA ® shipments comprise multi-dose and pre-filled syringe presentations of seasonal influenza vaccine. Both presentations were delivered either at or ahead of the projected delivery dates provided to customers.

AFLURIA is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. AFLURIA is approved for use in persons 5 years of age and older.

Select Safety Information
AFLURIA is contraindicated in individuals with known severe allergic reactions (eg, anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine.

Administration of CSL's 2010 Southern Hemisphere influenza vaccine was associated with postmarketing reports of increased rates of fever and febrile seizures in children predominantly below the age of 5 years as compared to previous years; these increased rates were confirmed by postmarketing studies. Febrile events were also observed in children 5 to less than 9 years of age.

If Guillain-Barré Syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give AFLURIA should be based on careful consideration of the potential benefits and risks.

If AFLURIA is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished. AFLURIA should be given to a pregnant woman only if clearly needed. AFLURIA has not been evaluated in nursing mothers. It is not known whether AFLURIA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when AFLURIA is administered to a nursing woman.

Antibody responses in persons 65 years of age and older were lower after administration of AFLURIA as compared to younger adult subjects. In children 5 through 17 years of age, the most common injection-site reactions observed in clinical studies with AFLURIA were pain, redness, and swelling. The most common systemic adverse events were headache, myalgia, malaise, and fever. In adults 18 through 64 years of age, the most common injection-site adverse reactions observed in clinical studies with AFLURIA were tenderness and pain. The most common systemic adverse reactions observed were headache, malaise, and muscle aches.

In adults 65 years of age and older, the most common injection-site adverse reactions observed in clinical studies with AFLURIA were tenderness and pain. Vaccination with AFLURIA may not protect all individuals. Before administering AFLURIA® (Influenza Vaccine), please read the Prescribing Information.

About CSL Biotherapies, Inc. CSL Biotherapies Inc., located in King of Prussia, PA, is the U.S. headquarters of bioCSL. Parent company CSL Limited has manufactured influenza vaccine in its Melbourne, Australia facility since 1968. CSL Limited has made a $60 million (U.S.D.) investment in plant and equipment to double capacity at its Melbourne facility, making it one of the largest vaccine manufacturing facilities in the world. CSL-branded influenza vaccines are approved in 28 countries. At bioCSL, delivering vaccines is our mission, protecting lives our passion. The CSL Group, which also includes CSL Research & Development, CSL Plasma, and CSL Behring, has more than 11,000 employees globally and operates in 26 countries around the world.


Media Contacts:
Sheila A. Burke, Director, Communications & Public Relations
Worldwide Commercial Operations
CSL Behring
610-878-4209 (o)

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