PATH is currently evaluating the benefits and applicability of disposable-syringe jet injectors (DSJIs) for developing-country immunization program use.
Our work examines both the clinical performance of the injectors as vaccine delivery devices and their acceptability (ergonomically, logistically, and economically) in clinics and developing-country immunization settings. By scientifically evaluating this technology class for delivering vaccines more safely and effectively in the developing world, we are working to provide new data to advance the knowledge and work of the global health community.
Our approach is to collaborate closely with multiple DSJI developers and members of the global health community to ensure that the class of technology is acceptable, sustainable, and cost-effective for low-infrastructure immunization settings worldwide.
About the technology
DSJIs are needle free. They use a sterile, single-dose syringe and a pressurized liquid stream to administer vaccines and medications to intradermal, subcutaneous, or intramuscular depths of injection. They are the only available needle-free technology that can deliver all injectable vaccines used in developing-country programs at all depths of delivery. DSJIs may improve injection safety in developing countries by eliminating needle and syringe reuse, preventing needlestick injuries, and reducing the overall burden of sharps waste.
DSJI’s sterile, single-use syringes alleviate past safety concerns with earlier needle-free injection technologies. New jet injectors avoid contamination due to splash back of body fluids into the nozzle orifice since sterile, single-dose syringes are used; and simple design allows for safe administration by many levels of health care professionals. No change is required in vaccine formulation, and the syringe is discarded after each single-dose use, thus preventing cross-contamination.
PATH has designed project activities to meet the key objectives of the DSJI project. The initial country selected for project activities is Brazil. PATH has completed several field assessments of different jet injectors in health clinics in Brazil to prepare PATH’s partners for future research and introduction.
PATH plans to conduct a clinical study with close to 600 children to evaluate the delivery of measles-mumps-rubella vaccine by DSJI as compared to needle and syringe beginning in the first quarter of 2010. Later studies include trials with yellow fever vaccine and other vaccines in the Brazilian immunization program. Brazil-based clinical trials represent an opportunity to test the technology in a receptive community with a history of jet injector use and the support of vaccine manufacturer Bio-Manguinhos.
PATH will also support clinical research using DSJIs to deliver reduced doses of certain vaccines intradermally. This research will involve collaboration with globally recognized vaccine manufacturers and other global public health stakeholders, such as the World Health Organization (WHO) and the United States Centers for Disease Control and Prevention (CDC). Past and present research on intradermal delivery indicates that this method could allow a reduction in the dose of vaccine needed and thus increase coverage for some vaccines that are in short supply. DSJIs could provide a reliable, needle-free means of administering these vaccines—potentially enabling a substantial cost-savings for immunization programs and improved vaccination coverage.
In addition to the clinical trials, the project work will also include an operational study in Brazil to help determine the commercial and programmatic feasibility of introducing DSJIs not only in Brazil but also in other developing- and emerging-economy markets. PATH will also work cooperatively with WHO to establish a Performance, Quality and Safety standard for the technology class to facilitate procurement of the DSJI device for developing-country immunization programs. More information on this standard is available from the WHO website.
Collaborators on the DSJI project
The PATH DSJI project involves collaboration with multiple DSJI developers as well as with public-sector organizations, such as WHO, CDC, and the Brazilian Ministry of Health. We support diverse research activities, facilitate connections between industry and the public sector, and provide technical expertise.
PATH’s approach to working with industry guides our involvement with several different DSJI developers. One such developer is PharmaJet, located in Golden, Colorado. PharmaJet is a privately held company that has developed a family of needle-free injection technologies. PharmaJet is particularly interested in developing-world applications, where low-cost, user-friendly, and robust technologies have particular promise for positive impact on the health and well being of communities.