bioCSL Inc. Launches AFLURIA® Shipping Campaign for 2014-2015 Seasonal Influenza
August 05 2014 - 8:00AM
Business Wire
- bioCSL Inc. to supply U.S. Market with
16.5 Million Doses
- Historical reliability, coupled with
dedicated commercial and production efforts, drive strong customer
prebook order demand
- Early season deliveries will support
U.S. providers’ 2014-15 vaccination needs
bioCSL Inc. announced today it has commenced shipping its
seasonal influenza vaccine AFLURIA (Influenza Vaccine) for
the 2014-2015 flu season. U.S. providers who ordered AFLURIA
may be able to begin vaccinating as early as this month.
Reflecting bioCSL’s longstanding commitment to public health and
improving seasonal influenza vaccination rates, bioCSL Inc. will
deliver about 16.5 million doses of the 2014-2015 formulation of
AFLURIA, with approximately 75 percent of doses in
thimerosal-free pre-filled syringes.
“Our historical operational focus on early and consistent
delivery has resulted in a strong customer prebook order demand for
the coming season,” said Dr. Marie Mazur, President of bioCSL Inc.
“We are committed to continuing to serve the needs of providers in
the United States, and want to ensure that they are prepared to
help prevent influenza in their communities.”
The impact of the 2013-14 influenza season was especially
detrimental to the health of 18-64 year old adults. Approximately
60 percent of the reported influenza-associated hospitalizations
were among people between the ages of 18 and 64. While the Centers
for Disease Control and Prevention (CDC) recommends that everyone
between the ages of 18-64 be vaccinated against the flu, this age
group lags behind the national average. Based on early season
estimates of people between the ages of 18 and 64, only 44 percent
who were at high risk and only 30 percent who were not at high risk
were vaccinated in the 2013/2014 season.
“With each influenza season comes new challenges,” said Dr.
Mazur. “The flu is a significant public health threat. bioCSL Inc.
strives to deliver vaccines to providers as early as possible to
give them ample time to vaccinate against the flu.”
About AFLURIA®
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 (e.g., 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
younger than 5 years of age, 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
pregnant women only if necessary. AFLURIA has not been
evaluated in nursing mothers. It is not known whether
AFLURIA can be excreted in human milk following
immunization. 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, please read the Prescribing
Information.
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 27 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
bioCSLNatalie de VaneMobile: 610-999-8756Office:
610-290-7403info@biocsl.com
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