PharmaJet’s Stratis® Needle-Free Injector Receives WHO PQS Certification as a Pre-qualified Delivery Device for Vaccine Administration

GOLDEN, Colo. – Feb. 20, 2013 – 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 journal’s July 2012 issue reported that 24 percent of adults and 63 percent 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 seven to 17 percent 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.

 

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].

Menu