PharmaJet’s Needless Injector Gets FDA OK to Deliver Flu Vaccine

PharmaJet Inc., the developer of a needle-free injection technology to administer medications and vaccines to patients, and bioCSL Inc., the maker of the Afluria influenza vaccine, received U.S. Food and Drug Administration (FDA) approval for the PharmaJet Stratis 0.5 milliliter needle-free jet injector for delivery of Afluria in patients ages 18 to 64.

It is the first needle-free delivery system approved by the FDA for the administration of an inactivated influenza vaccine.

“Healthcare providers now have the option of delivering Afluria without a needle,” said Ron Lowy, PharmaJet CEO and co-chairman. “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. We believe this is a significant step forward in the effort to improve public health through broader immunization coverage, as well as improved safety of caregivers.”

Needlestick injuries pose a serious risk to healthcare workers who administer vaccinations and manage sharps disposal. Among retail pharmacists alone, a National Institute for Occupational Safety and Health study revealed that the incidence of needlestick injury is up to 3.62 per 100,000 vaccinations administered. PharmaJet’s needle-free injection technology eliminates needlestick injuries, needle re-use and potential cross contamination, as well as reduces sharps waste management and disposal costs.

The PharmaJet injector delivers the vaccine by means of a narrow, precise fluid stream that penetrates the skin in about one-tenth of a second.

“The importance of being vaccinated yearly against seasonal influenza cannot be overstated,” said Dr. Marie Mazur, president of bioCSL Inc. “We are talking about a common respiratory infection that can affect anyone and that can lead to serious complications. Encouraging influenza vaccination acceptance requires a multi-pronged approach, including educating the public about the importance of influenza vaccination, ready access to vaccine and options for vaccine administration. PharmaJet’s needle-free technology, when used to administer Afluria, could play a significant role in increasing adult vaccination rates by helping to personalize vaccine delivery. We are pleased to be partnering with PharmaJet on this exciting new delivery option.”

The PharmaJet Stratis consists of a reusable Injector that delivers a single-dose with a disposable cartridge. Each injection consists of a narrow, precise fluid stream, which penetrates the skin in about one-tenth of a second. No external power source is required. The device contains an adapter that can be used with vaccine vials. FDA approval is 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 compared with traditional needle and syringe.

Based in Golden, Colo., PharmaJet’s needle-free injector has FDA 510(k) clearance, CE mark and WHO PQS certification to deliver medications and vaccines either intramuscularly or subcutaneously by means of a narrow, precise fluid stream.