FDA approves PharmaJet needle-free device for flu vaccine delivery

Medical Center of the Rockies researchers led trials for new technology in northern Colorado
September 22nd, 2014

LOVELAND, Colo.  – One of the latest advancements in flu prevention stems from a research study conducted by Medical Center of the Rockies researchers.

The U.S. Food and Drug Administration recently approved the first needle-free delivery system for the administration of an inactivated influenza vaccine. The device — the PharmaJet Stratis 0.5 mL Needle-Free Jet Injector — delivers the vaccine by means of a narrow, precise fluid stream that penetrates the skin in about one-tenth of a second.

It was the focus of a five-month long research study conducted at UCHealth facilities in northern Colorado in 2012 and 2013. The device was approved for delivery of AFLURIA®  influenza vaccine in people aged 18 to 64 years in August, according to Adam Jaskowiak, the director of clinical research at Medical Center of the Rockies in Loveland.

About 1,250 people – many of whom were UCHealth employees – took part in the study, Jaskowiak said. Researchers followed the participants for 30 days, measuring and comparing their immune response between the standard needle and syringe method versus the Pharmajet needle-free injection.

“This technology gives our community, and the world, a needle-free alternative for flu prevention,” said Dr. Gary Luckasen, medical director of research at MCR. “It is quicker, more efficient, and it reduces the amount of waste from traditional needles.”

The needle-free injection technology also is an especially important innovation for the millions of individuals who suffer from fear of needles and who consequently forego their annual flu vaccination, said Ron Lowy, the chief executive officer and co-chairman of Golden-based PharmaJet. “We believe this is a significant step forward in the effort to improve public health though broader immunization coverage, as well as improved safety of caregivers,” he added.

Needlestick injuries pose a serious risk to health care workers who administer vaccinations and manage sharps disposal. Among retail pharmacists alone, a National Institute for Occupational Safety and Health study reveals 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. It also reduces sharps waste management and disposal costs.

This is just one of approximately 40 studies conducted through the growing research department at MCR last year. The research has ranged in focus from cardiovascular trials to neurology studies, Jaskowiak said.

“UCHealth is on the forefront of many medical advancements. At MCR, we actively seek partnerships with local biotech companies to help develop their technologies. Not only does this give our community first access to some of the latest developments in medicine, but it also supports the biotech companies that are investing in the community and helps us to improve patient care in our own back yard,” he said.

WHAT IS THE PHARMAJET STRATIS?

  • Needle-free injection system that delivers a narrow, precise fluid stream through the skin in about one-tenth of a second.
  • Reusable injector that delivers a single-dose with a disposable cartridge.
  • Contains an adapter that can be used with vaccine vials.
  • No external power source required.
  • Approved by the FDA for delivery of AFLURIA® in August.

About UCHealth

UCHealth is a Front Range health system that delivers the highest quality patient care with the highest quality patient experience. University of Colorado Health combines Memorial Hospital, Poudre Valley Hospital, Medical Center of the Rockies, University of Colorado Hospital and a network of more than 40 medical clinics into one organization dedicated to health and providing unmatched patient care in the Rocky Mountain West. Separately, these institutions can continue providing superior care to patients and service to the communities they serve. Together, they push the boundaries of medicine, attracting more research funding, hosting more clinical trials and improving health through innovation.

MEDIA CONTACTS

UCHealth and Medical Center of the Rockies:
Kelly Tracer 970.237.7114 or Kelly.Tracer@UCHealth.org

PharmaJet:
Jill Thompson 720.438.8289 or jthompson@metzger.com,
Amanda King 720.833.5918 or aking@metzger.com

bioCSL Inc. (maker of AFLURIA®):
Anthony Farina, 302.545.0316 or anthony.farina@biocsl.com

 

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About the author

UCHealth is an innovative, nonprofit health system that delivers the highest quality medical care with an excellent patient experience. With 24,000 employees, UCHealth includes 12 acute-care full-service hospitals and hundreds of physicians across Colorado, southern Wyoming and western Nebraska. With University of Colorado Hospital on the Anschutz Medical Campus as its academic anchor and the only adult academic medical center in the region, UCHealth pushes the boundaries of medicine, providing advanced treatments and clinical trials and improving health through innovation.