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Helping You Protectevery Last Child

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Helping You Protectevery Last Child Helping You Protect Every Last Child. Tropis® – Information Dossier RATIONALE FOR fIPV WITH TROPIS® INTRADERMAL INJECTION SYSTEM INTRODUCTION Polio Eradication and Endgame Strategic Plan (Polio Endgame Strategy) 2013–2018 was developed in response to the World Health Assembly declaration in 2012 that the disease constitutes a global public health emergency. The plan includes the introduction of at least one dose of inactivated polio vaccine (IPV) into routine immunisation schedules. The information below summarizes the key reasons for introduction of IPV, challenges surrounding the strategy and consideration of Tropis® Needle-Free Injection System to mitigate the same.1 INCLUSION OF IPV INTO ROUTINE IMMUNISATION SCHEDULES IPV was first developed in 1955 and is given by injection. It is available only in trivalent form containing all the 3 virus serotypes which are known to cause disease. Oral Polio Vaccine (OPV) was initially introduced in early sixties as a monovalent vaccine and soon converted into a trivalent version (tOPV).1 GLOBAL CHALLENGE: IPV SHORTAGE The components of tOPV had to be relooked for the below reasons. There were no new cases of polio As part of the Polio Endgame Strategy and as recommended by the WHO, all 126 countries which at caused by serotype 2 for over 15 years. In contrast, there were several cases of serotype 2 vaccine the start of 2013 were only using OPV, were required to introduce at least 1 dose of IPV into routine associated paralytic polio. This led to the recommendation on the cessation of use of the serotype immunisation schedules. This would require an increase in the long-term supply of IPV provided by the 2 2 component of OPV and a switch from tOPV to bivalent OPV (bOPV), which contains types 1 and 3 vaccine manufacturers. viruses only. This bOPV has been licensed and used in some settings since December 2009. Following the planned global switch from tOPV to bOPV in April 2016, tOPV will no longer be available and will be Vaccine manufacturers had initially been confident that the scale-up of IPV production would ensure replaced by bOPV.1 sufficient capacity to meet the global demand for IPV. Unfortunately, the rapid scale-up of IPV production has encountered multiple challenges, leading to a global shortage in the available supply. In March 2016, WHO recommends the inclusion of at least one dose of IPV in the vaccination schedule for all countries the largest IPV supplier to the Global Polio Eradication Initiative (GPEI) announced an approximately 2 using OPV in the national immunisation programme. The primary purpose of this IPV dose is to induce 40% reduction in supply for 2016 and 2017, which are related to production scale up issues. an immunity base that could be rapidly boosted should there be an outbreak of polio due to poliovirus type 2 following the removal of serotype 2 virus from OPV. Additionally, depending on the timing of the The shortage in IPV supply is being managed globally, with prioritisation of IPV delivery to countries at administration of the dose or doses of IPV, the inclusion of IPV may reduce risks for the development of highest risk. Certain plans are put in place to mitigate risks should there be a delay in the receipt of IPV. vaccine-associated paralytic poliomyelitis and could boost immunity against poliovirus types 1 and 3 in One option is to provide an alternative to the intramuscular injection of a full IPV dose, wherein countries vaccine recipients.1 in any situation may choose the implementation of a two-dose fractional dose schedule (using 1/5 of a full dose), via the intradermal (ID) route.2 RATIONALE FOR fIPV WITH TROPIS® INTRADERMAL INJECTION SYSTEM FRACTIONAL DOSE IPV (fIPV) AND ITS EFFICACY BENEFITS OF TROPIS® INTRADERMAL INJECTION SYSTEM FOR Intradermal IPV administration with fractional doses of IPV (0.1 mL or 1/5 of a full dose) offers potential fIPV ADMINISTRATION cost reduction and allows immunisation of a larger number of persons with a given vaccine supply. Ongoing research on fIPV from the 1990s up to the recent years has come to demonstrate that two Tropis® Intradermal Injection System uses jet injector technology that propels liquid at high pressure to fractional doses administered intradermally offer higher immunogenicity compared to one full 0.5 mL deliver vaccines through the skin without utilising needles. intramuscular (IM) dose of IPV. Collectively, the data generated supports the strong recommendation from the WHO Strategic Advisory Group of Experts on Immunization (SAGE) for a two-dose fIPV schedule. The advantages of using the system are as follows: The following table summarizes the studies conducted comparing two ID fIPV doses with one full IM IPV Superior Coverage: It has a potential for dose-sparing by virtue of the fact that delivery can be targeted dose.3 to the intradermal layer. Considering that the dose of fIPV is 0.1 mL and two doses are to be administered, the total vaccine required is just 0.2 mL, in comparison with 0.5 mL which would be required for IM route; thus ensuring a 60% savings in amount of vaccine used. Thus, more than double the number of Schedule Seroconversion (%) Publication children benefit from the same quantity of vaccine when given via IM route.4 Country (Year) 2 fractional 1 full dose 2 fractional 1 full dose doses doses Greater Safety: Being a needle-free injection system, there is no fear of needle-stick injuries to Resik S, et al the healthcare workers or caregivers. The device is manufactured in such a manner that there is no Cuba 6, 10 weeks 6 weeks 55 36 (2010) opportunity for accidental or intentional reuse of the disposable syringes.4 Mohammed AJ, et Oman 2, 4 months 2 months 72 32 al (2010) Ease-of-use: A recent study assessed the feasibility of using the Tropis® Needle-Free Injection System for an intradermal fIPV campaign. In this study, eleven vaccinator teams underwent a two-day training Resik S, et al. Cuba 4, 8 months 4 months 98 63 and immunized 582 children between 4 months and 5 years of age. Application time was defined as time (2013) period from charging of the device till disposal of the used syringe. The average application time was 48 Anand A, et al. seconds which decreased towards campaign completion. The time of application of the vaccine using Bangladesh 6, 14 weeks 6 weeks 81 39 (2015) Tropis® Needle-Free Injection System is likely to be considerably shorter than traditional intradermal injections, though a head-to-head comparison has not been done. The vaccinators reported that filling the device and administration of the injection was easy. There was also no vaccine loss during the entire The approach of using two fractional doses instead of one full dose increases the immunogenicity of study. The authors concluded that it is feasible, safe and efficient to use the Tropis® Needle-Free Injection IPV and can extend coverage if supplies are limited. This dose sparing method could ensure that more System for the administration of fIPV in a campaign setting.5 eligible infants receive IPV and results in better immunogenicity than a single full dose of IPV. 3 In order to ensure early protection, a schedule of fractional intradermal doses administered at 6 and CONCLUSION 14 weeks from birth may be considered, ascertaining that the two fractional doses are separated by a In order to achieve global aim to successfully implement Polio Endgame Strategy and resolve the issue minimum interval of 4 weeks.3 of polio vaccine shortage, the introduction of a safe and effective solution is necessary. Tropis® Needle- free Injection System not only provides a quick, effective and safe solution to the polio vaccination CHALLENGES WITH ADMINISTRATION OF fIPV schedule, but also helps to address the global shortage of IPV by the introduction of fIPV, which is fully aligned with the WHO SAGE recommendation on immunization. Thus allowing for better immunization Intradermal delivery of fIPV using needle and syringe can be performed using the Mantoux technique, as well as helping to resolve vaccine shortage issue in order to achieve the Polio Endgame Strategy. wherein the needle is inserted at a narrow angle from the skin surface and the vaccine deposited underneath the skin. Generally, the procedure is considered to be slow and technically challenging, especially when vaccinating an infant. Intradermal vaccine delivery systems with the use of needle-free injectors could potentially alleviate this concern.4 2016, 91, 145-168 No 12 Weekly epidemiological record Relevé épidémiologique hebdomadaire 25 MARCH 2016, 91th YEAR / 25 MARS 2016, 91e ANNÉE No 12, 2016, 91, 145–168 http://www.who.int/wer Polio vaccines: WHO Note de synthèse de Contents position paper – March, l’OMS sur les vaccins 145 Polio vaccines: WHO position 2016 antipoliomyélitiques – paper – March, 2016 mars 2016 Sommaire Introduction Introduction In accordance with its mandate to provide Conformément à son mandat qui est de donner 145 Note de synthèse de l’OMS sur les vaccins antipoliomyéli- guidance to Member States on health aux États Membres des conseils sur les ques- tiques – mars 2016 policy matters, WHO issues a series of tions de politique de santé, l’OMS publie une regularly updated position papers on série de notes de synthèse régulièrement actua- vaccines and combinations of vaccines lisées sur les vaccins et les associations vacci- against diseases that have an international nales contre les maladies ayant un impact sur public health impact. These papers are la santé publique au niveau international. Ces concerned primarily with the use of notes portent essentiellement sur l’utilisation vaccines in large-scale immunization des vaccins dans le cadre des programmes de programmes.
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