FDA Approves Use of AFLURIA® Influenza Vaccine with PharmaJet’s Needle-Free Injector

  FDA Approves Use of AFLURIA® Influenza Vaccine with PharmaJet’s Needle-Free

 Jet injector device delivers single dose of injectable flu vaccine without a

Business Wire

KING OF PRUSSIA, Pa. & GOLDEN, Colo. -- August 19, 2014

PharmaJet^® Inc., the developer of a needle-free injection technology to
administer medications and vaccines to patients, and bioCSL Inc., the maker of
AFLURIA® (Influenza Vaccine) today announced the U.S. Food and Drug
Administration (FDA) has approved the PharmaJet Stratis® 0.5mL Needle-Free Jet
Injector for delivery of AFLURIA in individuals aged 18 to 64 years. This is
the first needle-free delivery system approved by the FDA for the
administration of an inactivated influenza vaccine.

“Healthcare providers now have the option of delivering AFLURIA without a
needle,” said Ron Lowy, PharmaJet CEO and co-chairman. “The PharmaJet
injection technology is an especially important innovation for the millions of
individuals who suffer from fear of needles and who consequently forego their
annual flu vaccination. We believe this is a significant step forward in the
effort to improve public health through broader immunization coverage, as well
as improved safety of caregivers.”

Needlestick injuries pose a serious risk to healthcare workers who administer
vaccinations and manage sharps disposal. Among retail pharmacists alone, a
National Institute for Occupational Safety and Health study reveals that the
incidence of needlestick injury is up to 3.62 per 100,000 vaccinations
administered. PharmaJet’s needle-free injection technology eliminates
needlestick injuries, needle re-use and potential cross contamination, as well
as reduces sharps waste management and disposal costs.

The PharmaJet injector delivers the vaccine by means of a narrow, precise
fluid stream that penetrates the skin in about one-tenth of a second. “The
importance of being vaccinated yearly against seasonal influenza cannot be
overstated,” said Dr. Marie Mazur, president of bioCSL Inc. “We are talking
about a common respiratory infection that can affect anyone and that can lead
to serious complications. Encouraging influenza vaccination acceptance
requires a multi-pronged approach, including educating the public about the
importance of influenza vaccination, ready access to vaccine and options for
vaccine administration. PharmaJet’s needle-free technology, when used to
administer AFLURIA, could play a significant role in increasing adult
vaccination rates by helping to personalize vaccine delivery. We are pleased
to be partnering with PharmaJet on this exciting new delivery option.”

About the PharmaJet Stratis®

The PharmaJet Stratis 0.5mL Needle-Free Injection System consists of a
reusable Injector that delivers a single-dose with a disposable cartridge.
Each injection consists of a narrow, precise fluid stream, which penetrates
the skin in about one-tenth of a second. No external power source is required.
The device contains an Adapter that can be used with vaccine vials. FDA
approval of the PharmaJet Stratis Needle-Free Injector is based on data from a
randomized controlled clinical trial that demonstrated non-inferiority of the
immune response to the three strains of influenza contained in AFLURIA when
the vaccine was administered with the Stratis Injector compared with
traditional needle and syringe.

About PharmaJet, Inc.

Based in Golden, Colorado, PharmaJet was founded with the goal of reducing the
use of medical needles throughout the world. PharmaJet’s innovative
Needle-Free Injector has U.S. FDA 510(k) marketing clearance, CE Mark and WHO
PQS certification to deliver medications and vaccines either intramuscularly
or subcutaneously by means of a narrow, precise fluid stream. The PharmaJet
Needle-Free Injector is easy-to-use and eliminates needlestick injuries,
needle re-use and cross contamination, and reduces sharps waste disposal. For
more information, please visit www.PharmaJet.com.

PharmaJet® and Stratis® are trademarks of PharmaJet Inc.


Influenza Vaccine, AFLURIA® is 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.

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

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

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

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 http://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 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.

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For PharmaJet
Jill Thompson, 720-438-8289
Amanda King, 720-833-5918
For bioCSL Inc.
Anthony Farina
Mobile: 302-545-0316
Office: 610-290-7403
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