The bioCSL produces the Influenza Vaccine AFLURIA.
PharmaJet noted the injector is the first needle-free delivery system approved by the FDA for the administration of an inactivated influenza vaccine.
PharmaJet CEO and co-chairman Ron Lowy said the healthcare providers now have the option of delivering AFLURIA without a needle.
"The PharmaJet injection technology is an especially important innovation for the millions of individuals who suffer from fear of needles and who consequently forego their annual flu vaccination," Lowy added.
The injection system includes a reusable injector, which delivers a single-dose with a disposable cartridge, as well as an adapter that can be used with vaccine vials.
The PharmaJet injector delivers the vaccine through a narrow and precise fluid stream, which penetrates the skin in about one-tenth of a second.
The approval was based on data from a randomized controlled clinical trial that demonstrated non-inferiority of the immune response to the three strains of influenza contained in AFLURIA, when the vaccine was administered with the Stratis Injector.
