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PharmaJet, CSL in Needle-free Flu Vax Pact

Will work to include jet injectors as delivery method for Afluria label

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By: Tim Wright

Editor-in-Chief, Contract Pharma

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.

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