CSL Limited has inked an agreement with PharmaJet to enable its Afluria® influenza vaccine to be delivered with the PharmaJet Stratis® needle-free jet injector. The company plans to seek FDA approval for the 2013–2014 flu season.
Adding PharmaJet jet injectors to the Afluria label will expand the delivery options for flu vaccine administration, and increase immunization compliance, according to the companies.
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 sharps disposal management. The PharmaJet Stratis device received FDA 510(k) marketing clearance in June.
In January 2011, the Centers for Disease Control gave PharmaJet a grant to develop needle-free injection devices for intradermal vaccine delivery. The benefits of intradermal delivery reportedly include reduction of the amount of vaccine required by as much as 80% in some cases, leading to cost savings and expanded coverage for vaccines in limited supply.
Afluria is a nonadjuvanted seasonal influenza vaccine sold in two different formulations: thimerosal-free, pre-filled syringes, and in multi-dose vials.
PharmaJet’s collaboration with CSL involves conducting a Phase IV clinical study to demonstrate the immunogenicity and safety of Afluria when administered with PharmaJet Stratis needle-free device.