IPAC BULLETIN. A note from the Chair: Chris Morgan. Inside this issue: December 2017 WORLD HEALTH ORGANIZATION. Dear colleagues,

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1 IPAC BULLETIN A note from the Chair: Volume 3, Issue 4 December 2017 WORLD HEALTH ORGANIZATION Dear colleagues, Welcome to the fourth IPAC bulletin for This is a time of change for immunization at WHO I m sure you will have noted the widely circulated call for a new Director of Immunization Vaccines and Biologicals the online recruitment for this on the WHO site closes on 16 th January 2018; so there s still time to tap someone on the shoulder if you have a good prospect! Plenty of good content in this bulletin: including news of a new Working Group and the latest on the influential Global Vaccine Action Plan progress assessment report, as well as the updates from our regular Working Groups. Of these, it was great to hear, via the Controlled Temperature Chain (CTC) teleconference in late December of the successful trial of feasibility of CTC for human papilloma virus vaccination in Uganda; exciting to see the potential of this strategy for enhancing programmes simplicity and reach. Craig Burgess reflections on the need to situate our discussions of immunization practice in the frameworks of Universal Health Coverage and the Sustainable Development Goals (SDG) are encouraging, especially as I study the benefits for immunization in greater integration of health services. Broader perspectives are important: I d like to mention two non-immunization studies that I ve found helpful this year. Karin Stenberg and colleagues from WHO health systems reviewed the investments in the whole health system needed to enable progress toward the SDGs ( S X(17) ); of interest to immunization programmes is their focus on people-centred service delivery platforms as a starting point. In the same way that IPAC has been discussing Total System Effectiveness in assessing immunization innovations, this paper reminds us of the need to ensure any consideration of costs and benefits extends across the whole health system. The other work I wish to bring to your attention is the collection of papers bringing to culmination eight years of review of the role of communitybased primary health care (CBPHC) ( jogh ) in promoting maternal, neonatal and child health. This raises the evidence base for primary health care, whose history is so integral to the Expanded Programme on Immunization. The data on effectiveness gives new confidence in CBPHC planning as a means to increase community engagement with front-line services; one key pathway to the renewal of vaccine confidence and demand that is essential to the future of immunization programmes. Another recent highlight in immunization practice has been the GRISP Scholar program. In the 2017 July bulletin, we referred members to WHO s Global Routine Immunization Strategies and Practices (GRISP) as a key resource. It has been excellent to see the GRISP Scholar programme take off, using GRISP as a means to trigger project-based action planning in countries, focused on transformative investments. This past month, TechNet-21 hosted a commencement event highlighting this programme, which allows participants to learn through connecting with EPI colleagues from over 30 countries through intense dialogue and peer review. Lastly, IPAC members will note that the March dates for our face-to-face meeting have had to be changed to mid-june. We apologise for the inconvenience of this change; it has not been done lightly and reflects our desire that our scheduled meetings make optimal use of members time, by ensuring that the right participants are available. This is an increasing challenge as the level of activity in the global immunization world continues to accelerate. And, the end of the year gives me the opportunity to acknowledge our gratitude to our partners and to IPAC members for their support, particularly through teleconferences and document review, as well as contributions to IPAC bulletins. I d like to close with heartfelt thanks to the IPAC secretariat at WHO, so ably led by Anna-Lea Kahn, and send you all very best wishes for this holiday season and for the New Year. Chris Morgan cmorgan@burnet.edu.au Inside this issue: From the Working Group frontlines 2 4 Release of 2017 GVAP Reports 4 UHC an IPAC member s perspective 5 Upcoming meetings and events 6 A final word from the IPAC Secretariat 6

2 Page 2 IPAC BULLETIN From the Working Group frontlines Update from the Secretariat of the Controlled Temperature Chain Working Group The CTC-WG has con nued to meet every two months by way of teleconference or webinars in order to discuss progress on the CTC agenda as it is defined in the CTC Strategic Roadmap. Most recently, on December 18th, the working group was presented an overview of the outcomes and lessons-learned emerging from the October 2017 pilot of HPV vaccine delivery through a Controlled Temperature Chain in Uganda. This pilot project consisted of adop ng the CTC strategy of vaccine delivery without a cold chain in two specific districts (Adjumani and Luweero) designated by the Ugandan na onal EPI program. The strategy was applied to school-based outreach ac vi es for the HPV vaccine and then evaluated through monitoring efforts and a survey of health-worker percep ons. The project was med to coincide with Uganda s Child Health Days, scheduled each year in October and April, during which HPV immuniza on efforts are concentrated. Photo:WHO-Uganda/ S. Zalwango; The specific HPV product that has been licensed and prequalified for CTC use since June 2016 is Merck s Gardasil 4. It is believed that delivering this vaccine through a CTC can yield cost savings, as well as program efficiencies allowing improved coverage and equity. CTC also reduces some risk associated with the mishandling of vaccines. This ini al HPV-CTC pilot focused on characterizing the op mal CTC approach in the context of HPV programs, while documen ng lessons-learned and determining the cri cal factors of success for an effec ve delivery of HPV through a CTC. The principal conclusion of this pilot was that CTC offers relief to health workers and is a welcome approach, however specific circumstances are required for its effec ve implementa on and to ensure that the benefits of CTC outweigh the poten al associated risks. These circumstances consist mainly of a well understood target popula on and appropriate microplanning efforts which allow for accurate es mates of needed vaccine during outreach efforts. In addi on, adequate training and supervision to ensure proper management of CTC excursions was shown to be instrumental. It was also recognized that CTC can only be applied to outreach ac- vi es that do not involve the integra on of addi onal non- CTC-approved vaccines. This is because the la er would require a fully effec ve cold chain thereby diminishing most of the benefits of CTC and limi ng the flexibility it offers, to the point of not making CTC worthwhile. Among the preliminary findings to emerge from this pilot were that while health workers generally favoured the CTC approach and implemented it correctly in both Luweero and Adjumani, they could not fully appreciate its benefits as they lacked recogni on of their own gaps in adequate cold chain adherence. Nevertheless, the study team was able to confirm that CTC helps overcome poor cold chain capacity and reduce such prevailing risks as exposure to freezing. The CTC implementa on effort was undermined in Uganda by a significant problem of confusion around the HPV target popula on and eligibility criteria. This lead to poor forecas ng and inadequate microplanning, which hampered supervisory efforts and caused a fair amount of vaccine to be wasted due to poor es ma ons of the ming and quan es needed for a given excursion. Lastly, it was determined that CTC could have been more successful with HPV immuniza on had the excursion allowance been longer than three days. The upper temperature limit was considerably less of an issue given that average ambient temperatures recorded during the study never exceeded 36 C. It was acknowledged that assessing economic benefits of CTC was beyond the scope of this ini al implementa on and best kept for a subsequent occasion when the approach is op mized and more representa ve of typical implementa on scenarios.

3 VOLUME 3, ISSUE 4 Page 3 Update from the Secretariat of the Delivery Technologies Working Group The DT-WG met twice over the last quarter, offering members insigh ul presenta on by guest speakers as follows: On 25 October 2017 the DT-WG hosted a presenta on on the Uniject TM injec on system by BD Medical - Pharmaceu cal Systems. The guest speakers was Roderick Hausser, Business Development & Opera ons Director BD Uniject TM BD Medical - Pharmaceu cal Systems. BD Uniject technology has been available for some me and is currently used to deliver HepB birth dose vaccines in Indonesia (produced by Bio Farma), was previously used to delivery TT in mul ple countries (past produc- on by Bio Farma), and is being introduced in mul ple countries for contracep on (Sayana Press, produced by Pfizer). The objec ve for this webinar was to bring the DT-WG up to speed with new developments in Uniject, help understand why it hasn t reached its full poten- al, and discuss the poten al future applica ons of this device. On 19 December 2017, a presenta on was offered on the Next Genera on DNA vaccina- on Approaches by Dr.Kate Broderick, Senior Director, Research and Development Inovio Pharmaceu cals, and Dr.Laurent Humeau, Senior Vice President, Research and Development Inovio Pharmaceu cals. Inovio s technology represents both a novel vaccine formula- on approach (DNA vaccines) as well as an alterna ve delivery technology (electropora on), and presents an approach for intramuscular and intradermal vaccina on. WHO is very interested in nucleic vaccine candidates for emerging/epidemic disease and infec- ous disease. It is also interested in the delivery aspect and whether these vaccines can be extended to rou ne immuniza- on as well, based on poten al costs and programma c suitability. It was considered to be important for the DT-WG to have conversa ons about upstream technologies like this to help inform the development process and guide suitability for lowresource se ngs. Mee ng minutes for each of these webinars are available on request from Birgi e Giersing of the DT-WG Secretariat. Announcing a new working group on Product Innovation, convened by Gavi. In the Gavi Secretariat Supply and Procurement Strategy, the Alliance reaffirmed innova on as one of three priori es in shaping markets to the benefit of the countries that Gavi supports, aiming to pursue a common agenda on driving product innova on to be er meet country needs and support Alliance goals on immunisa- on coverage and equity. To this end, the Alliance agreed to undertake a number of ac vi- es in : Understand varied countries needs by leveraging countries, and technical partners field experience to consider financial and nonfinancial impact of innova- ons (eg, safety, efficacy, equity and coverage); Develop common principles across the Alliance to make the assump ons underpinning the value proposi on for innova ons explicit. This includes considering the full trade-offs between financial and non-financial benefits for countries and feasibility to implement in countries. This also includes further developing and refining the Total Systems Effec veness model; Establish a pla orm and convene key partners to enable ar cula on of a clear and aligned perspec- ve on how and what to priori se in long-term innova on with a view to ul mately accessing the Gavi market, and communicate these priori es in a nonbinding manner to vaccine development partners. As a number of individual Alliance partners and other market-shaping intermediaries already engage in the innova on space, the Secretariat will convene these actors and leverage their rela ve capabili es, data and exper se. In this context and over 2017, an Alliance working group has been working on a landscaping of innova on-related ac vi es

4 Page 4 IPAC BULLETIN Working Group news (cont d from page 3) across the Alliance and gap analysis. Building on this learning, the group defined a scope, framework and process for a new shared Innova on Strategy. This leverages the exis ng capabili es, exper se and experience of current partners in immuniza- on innova on. The vision for this Innova on Strategy is one where Gavi, as the biggest funder of vaccines for LMICs, convenes Alliance partners under a single integrated framework that drives innova ons in product development, from pipeline to procurement. The details of the implementa- on of this ini a ve are s ll being defined and will be communicated with more precision at the next IPAC mee ng in Release of the 2017 Global Vaccine Action Plan Reports - by Christoph Steffen (GVAP Secretariat) The Global Vaccine Ac on Plan Reports for 2017 are now available for download through the WHO Global Vaccine Ac on Plan (GVAP) website. The yearly reports summarize progress against each of the GVAP indicators. They serve as basis for the annual independent review of progress made by the Strategic Advisory Group of Experts on immuniza on (SAGE) which in turn is discussed at the World Health Assembly. In 2016, some progress was made towards the goals set out in the Global Vaccine Ac on Plan (GVAP). The year saw the fewest number of cases of wild poliovirus ever reported, and three more countries were cer fied as having achieved maternal and neonatal tetanus elimina on. Nine addi onal countries have introduced new vaccines. Overall DTP3 vaccina on coverage increased, but by only 1% to 86%. Progress therefore s ll remains too slow for most goals to be reached by the end of the Decade of Vaccines in Furthermore, mul ple global, regional and na onal issues threaten further progress, and have the poten al to reverse hardwon gains. Economic uncertainty, conflicts and natural disasters, displacement and migra- on, and infec ous disease outbreaks all pose major challenges to immuniza on programmes. As the Decade of Vaccines draws to a close, there is a need to intensify global efforts to promote immuniza on and to address the systemic weaknesses that are limi ng equitable access to lifesaving and life-changing vaccines, par cularly in outlier countries and middle-income countries. The 2017 SAGE Assessment Report of the GVAP provides a series of key recommenda ons aimed at accelera ng progress and solu ons to key challenges. Well implemented these recommenda ons have a poten al to go far beyond protec ng people from vaccine-preventable diseases they promote the founda- on of resilient health systems for all. To facilitate the exploration of data analysis in the 2017 Secretariat Report, interactive data visualizations on progress against the goals and strategic objectives of the GVAP have been made available through the GVAP Indicators Portal. For further information on the Decade of Vaccines and the Global Vaccine Action Plan please visit the GVAP webpage or the DoV Secretariat : dovsecretariat@who.int. The GVAP Indicators Portal and Reports can be accessed from the GVAP website: global_vaccine_action_plan/ en/

5 VOLUME 3, ISSUE 4 Page 5 A New Year wish: delivering more to more by putting immunization programs at the heart of Universal Health Coverage - by Craig Burgess Immuniza on programs can play a central role in Universal Health Coverage (UHC). Unfortunately, immuniza on programs and UHC o en appear to inhabit parallel universes: program designers and implementers separated from health system planners and financers; upstream separated from downstream and product development separated from frontline customers. There is a need to bring these worlds together as immuniza on programs contribute to UHC in several ways: 1. Immuniza on delivery pla orms support UHC increasing popula on access: Although stagnant at 86% DTP3 global coverage rate, immuniza on programs s ll reach more vulnerable communi es (o en with the greatest disease burdens and risk of infec ous disease outbreaks) than any other health program. Outreach, microplanning, engaging communi es, using data for ac on, suppor ve supervision and strong supply chains are all cri cal elements for successful immuniza on programs that can be adapted for delivering other Primary Health Care (PHC) interven ons. This will be especially important as vulnerable popula ons increasingly live in fragile, displaced or urban se ngs; o en with weak Government infrastructure dependent on private sector or NGOs. 2. Integrated approaches can strengthen PHC: preven on and care for malaria, TB and HIV, antenatal, reproduc ve health and nutri on interven- ons could all be delivered at the same me as vaccines in PHC contexts, if integrated with vaccine delivery; 3. Immuniza on schedule along the life cycle: specific ages and mes for contact with health systems generate opportuni es to deliver other interven ons beyond just infancy to all stages of a person s life. Examples include delivery through schools, work places or to specific high risk popula ons; 4. Vaccines are one of the most cost effec ve health interven ons: vaccines (as part na onal schedule) need to be at the core of UHC essen al health packages to ensure funding and delivery of these effec ve interven ons are priori zed for those who need them the most. 5. Cos ng and transparent on-budge ng : Immuniza on programs cos ng and budge ng processes are o en ahead of other programs and must be protected as health investments rely on greater domes c resources and poli cal nego a- ons with donors and Ministries of Finance, transparently being on budget ; Immuniza on services can strengthen health systems: Investments in surveillance, supply and cold chains, monitoring processes and new vaccine introduc ons all present opportuni es to strengthen broader health systems, beyond just immuniza on programs. For more information on WHO s work on Universal Health Coverrage, including the December 2017 WHO News Release on UHC, please consult: universal_health_coverage/en/

6 VOLUME 3, ISSUE 4 Page 6 PLEASE TAKE NOTE: New dates for 2018 IPAC Meeting... The first quarter of 2018 is proving to be a busy season during which mul ple global and regional mee ngs have been scheduled, compe ng with IPAC for the presence and a en on of our members and par cipants. For this reason, it was decided that it would be more judicious to postpone our mee ng to later in the year. The most probable new ming will be mid-june and so we ask that you please block your calendars the week of June 11th. A confirma on of more specific dates will be communicated shortly. Please accept our apologies for any inconvenience this change in mee ng ming might cause you and thank you for your understanding. Upcoming Meetings / Events: January 2018 Meeting on Immunization Information Systems 6-7 March 2018 Meeting of the Polio SAGE Working Group March 2018 Bangkok, Thailand: Global Vaccine and Immunization Research Forum (GVIRF) March 2018 Meeting of the Malaria Vaccine Implementation Programme RTSS Programme Advisory Group April 2018 Meeting of the Strategic Advisory Group of Experts (SAGE) on Immunization A final word from the IPAC Secretariat This is a me of transi on in WHO s department for Immuniza on, Vaccines and Biologicals (IVB). In November 2017, the department had to bid farewell to both the IVB Director, Jean- Marie Okwo-Bele, and the EPI Coordinator, Thomas Cherian, as they took their re rement. Finding suitable replacements has been an ambi ous task that has yet to be completed. During this transi on, Mar n Friede (Coordinator for WHO's Ini a ve for Vaccine Research IVR) has been appointed to serve as Director, Ad Interim. It should also be noted that IVB currently sits within the cluster for Family, Women, Children and Adolescent Health (FWC) which is headed up by Dr Princess Nothemba (Nono) Simelela since October There is no doubt that 2018 will be a year filled with change and transforma on, along with the challenges and opportuni- es that typically accompany that. We will strive to keep you updated all along, but also thank you in advance for your pa ence and understanding during this evolu on. We are most grateful for the roles you have played in support of this Commi ee throughout the past year and look forward to more frui ul collabora on in the year to come. HAPPY NEW YEAR 2018! The IPAC Secretariat Team