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.