bioCSL and PharmaJet announced that the Food and Drug Administration (FDA) has approved the PharmaJet Stratis 0.5mL Needle-Free Jet Injector for delivery of Afluria (trivalent, inactivated “split virus” influenza vaccine) in patients aged 18–64 years.

This is the first needle-free formulation approved for an inactivated influenza vaccine. The FDA approval was based on results from a randomized controlled clinical trial that showed non-inferiority of the immune response to the 3 influenza strains contained in Afluria when administered with the Stratis Injector vs. traditional needle and syringe.

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The PharmaJet injector technology allows vaccine delivery through a narrow, precise fluid stream that penetrates the skin in about one-tenth of a second. The PharmaJet Stratis Needle-Free Injection System consists of a reusable injector that delivers a single-dose with a disposable cartridge. It contains an adapter that can be used with vaccine vials.

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