United States

bioCSL Inc. Completes 2014‐15 Flu Season Shipment of AFLURIA®

  • Approximately 16.2 million doses were delivered to providers
  • One of the first U.S. suppliers to complete 2014-2015 seasonal influenza vaccine shipping

KING OF PRUSSIA, PA — 10/20/2014

bioCSL, Inc. announced today that it has completed shipment of 16.2 million doses of AFLURIA® (Influenza Vaccine) for the 2014-2015 season and is now sold out. The Company’s distribution of 16.2 million doses represents a 45 percent increase in doses compared with the 2013-14 flu season for AFLURIA®.

"Influenza can be a very serious illness, and bioCSL is committed to supporting healthcare providers’ influenza vaccine needs in the United States," said Dr. Marie Mazur, President of bioCSL Inc. "Our early and consistent delivery of AFLURIA® ensures that providers have influenza vaccine to conduct their vaccination programs and help prevent the spread of influenza in the United States."

bioCSL's shipments of AFLURIA® influenza vaccine were comprised of pre-filled syringe presentations and multi-dose vials, which are approved for use with a needle and syringe or with the PharmaJet® Stratis® Needle-Free Injection System.

Important Safety Information

AFLURIA®, influenza vaccine, 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. Administration of AFLURIA with a needle and syringe is approved for use in persons 5 years of age and older. Administration of AFLURIA with the PharmaJet® Stratis® Needle-Free Injection System is approved for use in persons 18 through 64 years of age only.

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, most common injection-site adverse reactions observed in clinical studies of AFLURIA when administered by needle and syringe were pain, redness, and swelling. The most common systemic adverse events were headache, myalgia, irritability, malaise, and fever.

In adults 18 through 64 years of age, the most common injection-site adverse reactions observed in clinical studies of AFLURIA when administered by needle and syringe were tenderness, pain, swelling, and redness, itching. The most common systemic adverse reactions observed were muscle aches, headache and malaise.

In adults 18 through 64 years of age, the most common injection-site adverse reactions observed in clinical studies with AFLURIA when administered by the PharmaJet Stratis Needle-Free Injection System up to 7 days post-vaccination were tenderness, swelling, pain, redness, itching and bruising. The most common systemic adverse events within this period were myalgia, malaise, and headache.

In adults 65 years of age and older, the most common injection-site adverse reactions observed in clinical studies of AFLURIA when administered by needle and syringe were tenderness and pain.

Vaccination with AFLURIA may not protect all individuals.

Please see full prescribing information for AFLURIA.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

About bioCSL Inc.

bioCSL Inc. is the United States subsidiary of bioCSL and is headquartered in King of Prussia, Pennsylvania. bioCSL is part of the CSL Group (ASX:CSL), which employs more than 12,000 employees in 27 countries. It is headquartered in Melbourne, Australia.

bioCSL is a leading provider of essential vaccines, pharmaceuticals and diagnostic reagents. For over 50 years, bioCSL has manufactured seasonal and pandemic influenza vaccines. It operates one of the world's largest influenza vaccine manufacturing facilities in Australia, and maintains fill and finish facilities in the United States and Germany for the timely, reliable supply of influenza vaccines to global markets. Today, bioCSL's influenza vaccine is registered in 29 countries. bioCSL also specializes in the production of antivenoms and is the world’s only producer of Q Fever vaccine.

Visit bioCSL Inc. at www.biocsl-us.com

Media Contact:
Natalie de Vane
Mobile: 610-999-8756
Office- 610-290-7403
info@biocsl.com

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AFL14-10-0039 10/2014

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