PharmaJet Inc. has entered into a collaboration with CSL Limited to enable Afluria® influenza vaccine to be delivered with the PharmaJet Stratis® needle-free jet injector, as soon as the 2013-2014 flu season. Adding PharmaJet jet injectors to the Afluria® label will expand the delivery options for flu vaccine administration, thereby helping to broaden immunization coverage.
The Centers for Disease Control and Prevention (CDC) recommends an annual flu vaccination for all US citizens over 6 months old. Flu shots have proven to reduce illness, absenteeism and flu-related medical expenses. For many people, the fear of needles is enough to deter receiving a seasonal flu shot, despite the risk of contracting and spreading the illness.
Vaccine magazine's July 2012 issue reported that 24% of adults and 63% of children are fearful of needles and this has a direct relationship to immunization non-compliance. It is estimated that 7% to 17% of the US population choose to forego vaccinations due to fear of needle injections. Needle-free jet injectors have been used in the U.S. and other countries to deliver millions of vaccinations. PharmaJet injectors use pressure to create a fine stream of liquid that penetrates the skin, delivering doses to the desired depth, while eliminating needle-stick injuries, needle anxiety and the cost burden of "sharps" disposal management. The PharmaJet Stratis® device has received FDA 510(k) marketing clearance and provides easy and affordable injections, delivering vaccine in 1/5th of a second and with reduced pain sensation.
Afluria®, a CSL product, is a non-adjuvanted seasonal influenza vaccine sold in two different formulations: thimerosal-free, pre-filled syringes, and in multi-dose vials. CSL Biotherapies and PharmaJet are working to include jet injectors as a method of administration on the Afluria® label in time for the 2013-2014 flu season.
PharmaJet's collaboration with CSL involves conducting a Phase IV clinical study to demonstrate the immunogenicity and safety of Afluria®, presented in multi-dose vials, when administered with PharmaJet Stratis® needle-free device. Pending favorable clinical results, CSL will submit a Supplement to Afluria®'s BLA to include the option of needle-free jet injection on the Afluria® labeling.