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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).
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 countrie 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.
References
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].

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