PharmaJet's Stratis® Needle-free Injector Receives WHO PQS Certification as a Pre-qualified Delivery Device for Vaccine Administration
GOLDEN, Colo.--(BUSINESS WIRE)--PharmaJet Inc. has become the first and only needle-free injection company to receive Performance, Quality and Safety (PQS) pre-qualified certification from the World Health Organization (WHO).
"Survey of the Prevalence of Immunization Non-compliance Due to Needle Fears in Children and Adults"."
The WHO uses its Department of Immunization, Vaccines and Biologicals to pre-qualify vaccines and devices for safe immunizations. The Quality, Safety and Standards Team pre-qualifies a comprehensive range of cold chain equipment, injection devices and other products needed for safe and effective immunization delivery. PQS certification allows purchase and use of Stratis® jet injectors for mass immunization campaigns by WHO, The Global Alliance for Vaccines and Immunization (GAVI) and UNICEF worldwide.
Vaccine magazine's July 2012 issue reported that 24% of adults and 63% of children in the U.S. are fearful of needles and this has a direct impact on immunization non-compliance.1 It is estimated that 7% to 17% of the U.S. population choose to forego vaccinations due to fear of needles.2 Needle-free jet injectors have been used in the U.S. and other countries to deliver millions of vaccinations.3
The PharmaJet Stratis® needle-free injection system received FDA 510(k) clearance in July 2011 for delivery of various medications and vaccines and also achieved CE Marking in 2012 allowing use in the European Economic Area.
About PharmaJet Inc. and Needle-free Injection Technology:
PharmaJet's innovative needle-free injection technology delivers drugs and vaccines to intramuscular, subcutaneous and intradermal tissue depths. PharmaJet injectors use pressure to create a fine stream of liquid that penetrates the skin, delivering doses to the desired depth, while eliminating risks of needle-stick injuries and the cost burden of "sharps" waste management. Further benefits of PharmaJet injectors include the potential for dose-sparing of vaccines, reducing the overall cost of vaccine delivery. PharmaJet's needle-free injectors have received FDA 510(k) marketing clearances for use to deliver various liquid medicines and vaccines. The PharmaJet system has been well received in the developed world, and is also advantageous in the developing world due to its usability, affordability and inherent safety features. For more information on PharmaJet's needle-free injection technology, please visit http://www.pharmajet.com/.
PharmaJet® and Stratis® are trademarks of PharmaJet Inc.
1. Vaccine, Volume 30, Issue 32, 6 July 2012, pp 4807-4812, "Survey of the Prevalence of Immunization Non-compliance Due to Needle Fears in Children and Adults".
2. The American Journal of Medicine, Vol. 121, No. 7B, July 2008, Johnson et al, "Barriers to Adult Immunization", pp S28-S35.
3. Vaccines, 5th ed. Philadelphia, PA: Saunders (Elsevier); 2008; 1357-1392, Weniger BG, Papania MJ, "Alternative Vaccine Delivery Methods" [Chapter 61].
Shannon O'Reilly, 1.303.526.4278