Bioject to provide needle-free injector for Global Polio Eradication Initiative study

22 Feb 2011

Bioject Medical Technologies Inc, a developer of needle-free injection systems, has announced its support for clinical research of intradermal delivery of vaccines in developing-country immunization programs.

 Bioject will provide its Intradermal (ID) Pen — a disposable-syringe jet injector (DSJI) for ID delivery — to the World Health Organization (WHO) and PATH, an international nonprofit organization, to advance the use of DSJIs for use in developing countries to reduce risks associated with needle reuse and needlestick injuries.

WHO and PATH will each provide funding to Bioject for the production of ID Pen devices for further evaluation.

Bioject's ID Pen spring-powered needle-free injector — which is currently under development and not yet cleared by the FDA — is intended to be used for intradermal injections for vaccinations and drug therapy.

The system consists of a hand-held, user-filled device that incorporates single-use, auto-disable disposable syringes. The moulded syringes have orifices about the thickness of a human hair, through which the liquid drug is forced into the skin. The ID Pen is designed to deliver 0.05 mL or 0.10 mL for each injection. The injector is entirely mechanical and is intended for administration by trained health workers.

For some vaccines, ID vaccine delivery can achieve the same results as an intramuscular or subcutaneous injection — fully immunizing beneficiaries but using up to 80% less vaccine. Reduced dosage is appealing to immunization programs because it has the potential to simultaneously increase vaccine availability and decrease costs associated with vaccine delivery.

Since accurate and reliable ID delivery is difficult to ensure, particularly in low-resource settings, new delivery technologies like Bioject’s ID Pen injector may make the method more appropriate for use in the developing world. This could result in more children being vaccinated, particularly in developing countries.

The ID Pen is intended to improve the safety and ease of ID delivery of vaccines and could enable immunization programs to stretch their vaccine supplies across a larger number of beneficiaries.

This collaboration is part of ongoing research by the Global Polio Eradication Initiative (GPEI) to prepare for the post-eradication era of polio, a disease slated for worldwide eradication in the near term.

For countries that perceive that the risks warrant continued immunization against polio after eradication, inactivated polio vaccine (IPV) is currently the only option with which to do this, and the GPEI is studying a range of approaches to establish affordable strategies for IPV use in low-income settings. WHO, PATH, and Bioject recently collaborated on a research study on fractional doses of IPV delivered intradermally using the Biojector 2000 to infants in Oman.

The study results were published in 2010 in The New England Journal of Medicine and showed successful ID administration in addition to potential cost savings of the fractional dose when compared to the cost of full-dose vaccination using a traditional needle and syringe. The hope is that this new device could make IPV affordable for developing-country use and stretch the limited supply of IPV, crucial for polio post-eradication planning. At the same time, it could go a long way to getting rid of needles altogether in routine immunization programs.

“We are very excited to enter into this new collaboration, which advances the development of a new state-of-art needle-free ID Pen injector, especially after learning of the exciting study results reported in the New England Journal of Medicine using our established B2000 device to investigate intradermal delivery of polio vaccine.

This new ID Pen injector will provide the needed technology for delivery of vaccines and drugs using the intradermal approach and perhaps allow a dose sparing effect,said Dr. Richard Stout, Bioject’s Executive Vice President and Chief Medical Officer. “We appreciate the leadership, support and foresight of our collaborators to help bring this innovative technology to patients, caregivers, and the global medical community,” commented Dr. Stout.

PATH is working to expand access to vaccines by those who need them most. This work will help advance the class of needle-free injection technologies for developing-country immunization programs and contribute to a body of work that improves vaccine delivery safety.

DSJIs eliminate the risk of needle reuse and needlestick injuries, and PATH is conducting a cost-modeling analysis to see how costs to immunization programs compare with traditional needle and syringe. PATH is also comparing general acceptability of these alternative devices with typical administration practices and testing effectiveness for delivery of certain vaccines.


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