FDA Approves First Needle-Free Flu Vaccine Injector

The FDA has approved the first needle-free device for injecting the Afluria influenza vaccine in adult patients aged 18 to 64 years.

In a survey of 100 health care providers conducted by bioCSL, Inc, the maker of Afluria, 60% of respondents said needle-free options like the PharmaJet Stratis 0.5ml could help increase vaccination compliance by 10% or more. Because nearly one-quarter of US adults surveyed in a 2012 online poll by Target Corp and Harris Interactive said they would skip getting vaccinated against the flu due to fear of needles, PharmJet’s needle-free technology “could play a significant role in increasing adult vaccination rates,” bioCSL President Marie Mazur, MD, noted in a press release.

“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,” PharmaJet CEO and co-chairman Ron Lowy stressed in the press release. “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.”

In addition to curbing patients’ fears of needles, the PharmaJet injection technology eliminates needlestick injuries that pose a serious risk to health care workers who administer vaccinations and manage sharps disposal, the press release noted. Among retail pharmacists alone, the incidence of needlestick injury is up to 3.62 per 100,000 vaccinations, according to a study from the National Institute for Occupational Safety and Health.

Unlike the traditional needle and syringe delivery method, the PharmaJet injector administers a single dose of Afluria vaccine through a narrow, precise fluid stream that penetrates the skin in roughly one-tenth of a second. The FDA’s approval of the needle-free injector was based on data from a randomized trial that demonstrated noninferiority of immune response to the 3 strains of influenza contained in Afluria when the vaccine was administered with the Stratis Injector, compared to a needle and syringe.