PharmaJet has entered into a collaboration with CSL Ltd. to enable Afluria flu vaccine to be delivered with PharmaJet’s Stratis needle-free jet injector for the 2013-14 flu season. PharmaJet injectors use pressure to create a fine stream of liquid that penetrates the skin, while eliminating needle-stick injuries, needle anxiety and the cost burden of “sharps” disposal. The PharmaJet Stratis device has received FDA 510(k) marketing clearance and delivers vaccine in one-fifth of a second with reduced pain sensation.
CSL’s Afluria is a non-adjuvanted seasonal flu vaccine sold in two different formulations: thimerosal-free, pre-filled syringes, and in multi-dose vials. CSL and PharmaJet are working to include jet injectors as a method of administration on the Afluria label for the 2013-2014 flu season.
The collaboration involves conducting a Phase IV study to demonstrate immunogenicity and safety of Afluria presented in multi-dose vials, when administered with the Stratis needle-free device. CSL will submit a Supplement to Afluria’s BLA to include the needle-free jet injection option.