Polio is a crippling and potentially fatal infectious disease, mainly affecting children under five years old, and there is no cure. It is estimated that less than half the amount of vaccine is available to support the global demand, and this shortage is anticipated to continue for years to come. 1,2
As part of its Global Polio Eradication Initiative (GPEI), the World Health Organization has been working closely with PATH and the Gates Foundation to clinically evaluate alternate delivery options and technologies, including fractional dose needle-free delivery, to address increases in demand and vaccine supply shortages.3
Multiple clinical studies evaluated the effectiveness of one full dose of polio vaccine (0.5mL) administered intramuscularly vs. two fractional doses (0.1mL) administered intradermally, with either a needle and syringe or a needle-free injection device (PharmaJet® Tropis®). The studies found that two fractional doses of intradermal IPV (fIPV) (2 doses x 0.1mL) were superior to one full dose (0.5mL) administered intramuscularly4, thus using 60% less vaccine.5 This means 2-3x more children can be vaccinated with the same amount of vaccine.
Fractional dose polio vaccine delivery has been endorsed by the WHO and the Indian Ministry of Health, as it provides a more cost effective option that will enable routine immunization to 2 to 3 times more children. Specifically, the WHO Strategic Advisory Group of Experts (SAGE) recommends that countries adopt a two fractional dose IPV schedule in the routine immunization and outbreak response.7 The Technical Advisory Group on Vaccine-preventable Diseases (TAG) and Pan American Health Organization (PAHO) endorsement states that “countries that administer more than 100,000 doses of IPV each year and have the capability to adequately train health care workers and supervise implementation should immediately begin to prepare to implement a fractional dose IPV schedule. These countries include Argentina, Bolivia, Brazil, Chile, Colombia, Cuba, Ecuador, El Salvador, Honduras, Nicaragua, Paraguay, Peru, Uruguay and Venezuela.”8
While the clinical studies provided a workable solution for the supply shortage, they also recognized the ongoing difficulty of administering vaccines intradermally with the Mantoux technique using a needle and syringe. Administration can be slow, technically difficult and painful. Additionally, many health care workers are not familiar with the intradermal technique, making it unsuitable for house-to-house campaigns, and the inconsistent delivery is less than ideal for mass immunizations. Conversely, the PharmaJet needle-free Injector is easy-to-use and requires minimal training. Health care workers that have used the device found that they quickly became proficient in providing consistent and rapid injections.9
The PharmaJet needle-free Injector delivers the vaccine by means of a precise, narrow fluid stream that quickly penetrates the skin in about 1/10th of a second. Its simple point and click design ensures consistent and accurate intradermal injection. The preparation and administration time is 50-70% less than needle and syringe, making it an ideal choice for vaccination campaigns.10 And, because there is no needle, health care workers can work fast and not have to worry about needle sticks. Additionally, the auto-disabling syringe precludes any possibility of reuse, a problem with some needles.
Having a needle-free device available to administer polio vaccines also provides an important safety benefit. Needle sticks have been an ongoing safety issue accounting for 33,800 new HIV infections, 1.7 million hepatitis B Infections and 315,000 hepatitis C infections annually.11 In addition, as many as 500 million used needles are added to trash dumps and landfills every year and 75 million of those needles may be infected with blood borne illnesses.11 No needle means no needle-trash.
The PharmaJet needle-free device is currently being used as part of the polio eradication effort in Bangladesh, Cuba, Gambia and Pakistan. PharmaJet needle-free devices are also being used to administer flu vaccinations in the U.S. and measles immunizations in Cambodia and India.
- IPV introduction and RI strengthening, WHO; http://www.who.int/immunization/diseases/poliomyelitis/endgame_objective2/inactivated_polio_vaccine/en/
- Inactivated Polio Vaccine Supply and Demand Update, September 2016, Unicef Supply Division; https://www.unicef.org/supply/files/Inactivated_Polio_Vaccine_(IPV)_-_september_2016.pdf
- To help end polio, intradermal delivery takes center stage, Vaccine and Pharmaceutical Technologies News and Updates – PATH, May 2016, http://www.path.org/newsletters/vaccine-technologies-newsletter.php
- Immunogenicity to poliovirus type 2 following two doses of fractional intradermal inactivated poliovirus vaccine: A novel dose sparing immunization schedule. Anand A., et al. Vaccine, 2017 May 19:35(22):2993-2998; https://www.ncbi.nlm.nih.gov/pubmed/28434691
- Early priming with inactivated poliovirus vaccine (IPV) and intradermal fractional dose IPV administered by a microneedle device: A randomized controlled trial, Anand A., et al., Vaccine. 2017 May 19;35(22):2993-2998. doi: 10.1016/j.vaccine.2017.03.008. Epub 2017 Apr 20.
- Use of fractional dose IPV in routine immunization programmes: Considerations for decision-making, WHO Polio Global Eradication Initiative, March 2017; http://www.who.int/immunization/diseases/poliomyelitis/endgame_objective2/inactivated_polio_vaccine/fIPV_considerations_for_decision-making_March2017.pdf?ua=1
- Weekly epidemiological record, World Health Organization, June 2, 2017, page 309, http://apps.who.int/iris/bitstream/10665/255611/1/WER9222.pdf?ua=1
- Ad hoc Virtual TAG Meeting 20176, 10, March 2017, Washington D.C., USA, p. 7; http://www.who.int/immunization/sage/meetings/2017/april/6_2017_TAG_Ad-hoc_Meeting_Report_EN.pdf
- PharmaJet Inc., Doc. #60-10214-001A Cambodia Healthcare Worker Interview Video
- Intradermal Administration of Fractional Dose of Inactivated Poliovirus Vaccine (fIPV) Using Tropis® Intradermal Needle Free Injection System, Karachi Pakistan, Community Based Polio Vaccination Campaign, December 2016; Ali Faisal Saleem, Mach Ondrej, Muhammad Tahir Yousafzai, Attaullah Baig, Roland Sutter, Anita KM Zaidi, Aga Khan University, Karachi Pakistan, WHO, Geneva, Switzerland
- Health-care waste, World Health Organization Fact sheet No 253, November 2015; http://www.who.int/mediacentre/factsheets/fs253/en/