GOLDEN, Colo. – September 30, 2014 – A clinical study published in the August 23, 2014 issue of The Lancet demonstrated that delivery of AFLURIA® (Influenza Vaccine) with the PharmaJet Needle-Free Injector compared favorably to traditional needle and syringe delivery. The U.S. Food and Drug Administration (FDA) recently approved the Stratis® 0.5mL Needle-Free Jet Injector for delivery of AFLURIA in people aged 18 through 64 years. It is the first influenza vaccine in the U.S. to be labeled for administration with a jet injector and will be available for use during the upcoming 2014-2015 flu vaccination season.
“This is the first definitive clinical study to compare the immunogenic non-inferiority of jet injection technology versus needle and syringe for the administration of influenza vaccine,” said Linda McAllister MD, PhD, lead investigator of the study. “The results show the comparability of the PharmaJet Needle-Free Jet Injector to needle and syringe, supporting the wider use of these devices. These devices can help eliminate needlestick injuries, needle re-use and potential cross contamination, as well as create a more comfortable experience for patients who fear needles.”
The Centers for Disease Control and Prevention (CDC) recommends annual flu shots for all adults, yet only around 40 percent of them receive a flu vaccination each year. Of those who forego flu vaccination, a recent report showed that nearly one-quarter (1/4) skip being vaccinated because they don’t like needles. In the PharmaJet study, 89 percent of the people receiving the PharmaJet Needle-Free Injection reported they would choose to receive this type of injection again.
“We are pleased the study findings support the use of jet injection technology as an alternative to needle and syringe,” said Ron Lowy, CEO and co-chairman of PharmaJet, Inc. “The PharmaJet Needle-Free Injector addresses both caregiver safety concerns and patient issues with needles. This technology can help remove barriers to full immunization of the public.”
Study Design and Findings
A randomized, comparator-controlled trial was undertaken during the 2012–2013 Northern Hemisphere influenza season. The participants, 1,250 healthy adults, aged 18-64 were randomly assigned to receive a single dose of AFLURIA intramuscularly with either the PharmaJet Needle-Free Injector or with needle and syringe. The primary objective was to demonstrate that six co-primary endpoints, the three strain-specific geometric mean titer (GMT) ratios and the absolute difference in three strain-specific seroconversion rates, met the criteria for non-inferiority of the PharmaJet Needle-Free Injector compared with needle and syringe. The study found that the immune response to AFLURIA when administered by the PharmaJet Needle-Free Injector met the criteria for non-inferiority for all six co-primary endpoints, and had a clinically accepted safety profile.
About the PharmaJet Needle-Free Injection System
The PharmaJet Stratis 0.5mL Jet Injection System consists of a reusable Injector that delivers a single-dose of liquid vaccine or medicine with a disposable Needle-Free Syringe. 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. FDA approval of the PharmaJet Stratis Needle-Free Injector was granted in 2011. Data from this randomized, controlled clinical trial demonstrated immunogenic non-inferiority, for the three strains of influenza contained in AFLURIA, when the vaccine was administered with the PharmaJet Needle-Free 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 Stratis® Injector has U.S. FDA 510(k) marketing clearance, CE Mark and WHO PQS certification to deliver medications and vaccines either intramuscularly or subcutaneously. The PharmaJet Needle-Free Injector is easy-to-use and eliminates needlestick injuries, needle re-use and cross contamination, and helps reduce “sharps” waste disposal. For more information, please visit www.PharmaJet.com.
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. 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 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 http://www.fda.gov/medwatch or call 1-800-FDA-1088.
PharmaJet and Stratis are registered trademarks of PharmaJet Inc.
AFLURIA is a registered trademark of CSL Limited used under license.
Contacts: For PharmaJet
Jill Thompson (720-438-8289)
Amanda King (720-833-5918)