Oman's immunisation programme polio vaccine trial to showcase use of Jet Injector
MUSCAT -- Needle-free injection technology currently being used in a key polio vaccine trial under way in the Sultanate, could someday replace the use of needles and syringes in Oman's mass immunisation programme, health officials say. Needle-free injections, they point out, will result in improved safety for patients, healthcare workers and the community.
Earlier this week, the Health Ministry's Department of Communicable Disease Surveillance and Control (DCDSC) hosted a workshop for a group of clinicians aimed at acquainting them with the application of needle-free injection technology in the ongoing vaccine trial. The workshop was conducted by Marilyn Moore of Bioject Inc, a US-based company whose 'Biojector' needle-free injection device has been selected for use in the vaccine trial.
Also present at the workshop was Kimberly Kelly, Clinical Research Coordinator and Programme Officer at PATH, a US-based non-governmental organisation which is collaborating with the World Health Organisation (WHO) and the Atlanta-based Centre for Disease Control and Prevention (CDC) in evaluating the feasibility of using jet-injectors to completely replace needle and syringe in developing countries.
The study aims to prove that enhanced potency inactivated poliovirus vaccine (IPV), currently the anti-polio vaccine of choice in industrialised countries, can also be economically introduced in poorer nations. At present, limited worldwide capacity and the relatively high cost of IPV makes it less affordable for use in poorer countries as a means of disease-outbreak control.
Scientists believe that protective immunity against poliomyelitis can be achieved by administering a fraction of a dose of IPV. If indeed proven to be the case, this will both increase the current capacity, and correspondingly decrease the cost of the dose of the vaccine. Studies conducted so far indicate that this is feasible by intradermal delivery of the vaccine.
The Oman study aims to demonstrate that a schedule of three fractional doses of IPV is no less inferior to a full dose of IPV. The data generated by this clinical trial will facilitate regulatory approval for the manufacture of fractional doses of IPV using a needle-free device known as a 'Jet Injector'. While safe intradermal injection with needle-and-syringe requires extensive training, the use of jet injectors for intradermal delivery is highly reliable and requires only minimal training. Furthermore, jet injectors permit needle-free injection, and if applied to all vaccines, will result in the complete elimination of sharps from the immunisation process.
Four study sites -- Rustaq, Sur, Nizwa and Salalah -- have been identified for the implementation of the vaccine trial in the Sultanate. The roughly seven-month-long study will cover 100 newborn babies at each location. According to Marilyn Moore, the Biojector selected for the trial is a high-speed delivery system designed to inject medication intra-dermally or intramuscularly without a needle. The device employs compressed carbon dioxide as a power source to eject the vaccine or medication through a tiny orifice in a fraction of a second, effectively penetrating the skin.
The Biojector uses a fill needle or vial adapter to draw up the vaccine from a standard vial. Once the disposable syringe is filled, the fill needle or vial adapter is discarded prior to administering the injection.
Only the blunt-end plastic syringe comes in contact with the patient's skin. Thus, concern over transmitting blood borne pathogens through a needle stick injury is eliminated, since there is no contamination. Besides, most people report little or no pain with a Biojector injection, says Moore.
The WHO estimates that up to half of all injections in the world are unsafe because the needle or syringe has been improperly reused without sterilisation. Transmissions of blood borne pathogens such as HIV and Hepatitis B virus to patients, healthcare workers and community members can occur from unsterile injections, accidental needle sticks, and improper 'recycling' of needles and syringes.
By Conrad Prabhu
© Oman Daily Observer 2007
