bioCSL Inc. Begins Shipping AFLURIA for the 2015-2016 US Seasonal Influenza Campaign

KING OF PRUSSIA, Pa., July 13, 2015 /PRNewswire/ -- bioCSL Inc. announced today it has begun shipping AFLURIA, Influenza Vaccine in advance of the 2015-2016 influenza season. In support of improving seasonal influenza vaccination rates to protect public health, bioCSL will deliver more than 18 million doses of AFLURIA to the US market, a 20 percent increase over last year.

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"At bioCSL, we are focused on meeting the needs of healthcare providers for a safe and reliable vaccine supply," said Dr. Chip Altman, Head of Medical Affairs, bioCSL Inc. "Seasonal influenza is a major public health concern, and we strive to deliver vaccines to providers in the United States as early as possible to give them ample time to protect their communities against the flu."

Approximately two thirds of AFLURIA doses will be available in single-dose, thimerosal-free, pre-filled syringes. One third will be in multi-dose vials (containing thimerosal as a preservative). A new needle-free option of administering AFLURIA using multi-dose vials is now available. AFLURIA is the only influenza vaccine FDA approved for administration via the PharmaJet Stratis® Needle-Free Injection System (available from PharmaJet Inc.) which allows administration of AFLURIA without a needle to adults, aged 18 to 64, including those who may forgo flu shots due to a fear of needles.

The Centers for Disease Control and Prevention recommends routine seasonal influenza vaccination for all individuals 6 months of age and older. AFLURIA is indicated for individuals 5 years of age and older.

While young children and the elderly are most often vaccinated against influenza, vaccination rates for adults 18-64 years, lag behind the national average.

About Seasonal Influenza
Seasonal influenza is a serious, contagious respiratory illness caused by influenza viruses that infect the nose, throat and lungs. Approximately 5-20 percent of Americans get the flu each year, resulting in more than 200,000 hospitalizations. Flu is transmitted via respiratory droplets spread through coughing, sneezing and talking. Flu can also be contracted by touching a surface or object that has the flu virus on it, and then touching the mouth, eyes or nose. Flu is unpredictable, as the timing and prevalence of circulating strains can shift in different parts of the country and from season to season. For this reason, the Centers for Disease Control and Prevention (CDC) recommends vaccination each year as the best method of protection.

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-Barre 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, redness, and 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 of 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 or call 1-800-FDA-1088.

About bioCSL Inc.
bioCSL Inc., which is based in King of Prussia, Pennsylvania, is the United States subsidiary of CSL Limited (ASX: CSL), a Melbourne, Australia-based company that employs more than 12,000 people in 27 countries. bioCSL is a leading provider of essential vaccines, pharmaceuticals and diagnostic reagents, and for nearly 50 years, 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 and reliable supply of influenza vaccines to global markets. Today, bioCSL influenza vaccines are registered in 31 countries. bioCSL also specializes in the production of antivenoms and is the world's only producer of Q Fever vaccine.

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