Issue 12, April 2012

MenAfriVac™ planned for use in a controlled temperature chainby Simona Zipursky, project Optimize (PATH); Jean-Marie Préaud, Meningitis Vaccine Project (PATH); and Mamoudou Harouna Djingarey, WHO Regional Office for Africa

The World Health Organization (WHO) and PATH are collaborating with the Drug Controller General of India, Health Canada, and Serum Institute of India to obtain a license variation for MenAfriVac™, the meningitis A conjugate vaccine developed through the Meningitis Vaccine Project. If approved, the variation will allow countries to distribute the vaccine in a controlled temperature chain (CTC) outside the traditional 2°C to 8°C range.

Almost all vaccines used in immunization programs today are licensed for storage and distribution within a temperature-controlled supply chain of between 2°C and 8°C. However, keeping vaccines within this range is extremely difficult in countries with limited cold chain and ice pack production capacity. Many immunization campaigns encounter this problem, including the MenAfriVac campaign in the meningitis belt of sub-Saharan Africa. This vaccine will be introduced in 25 countries by 2016 and has the potential to eliminate epidemic meningitis as a public health problem. With 55 million people already vaccinated, MenAfriVac must still be delivered to almost 400 million people. In countries with some of the weakest supporting infrastructure, the logistical challenges of maintaining the cold chain—from faltering electricity, poorly functioning or absent equipment, to ice pack production—are immense.

Thankfully, many vaccines are actually more heat stable than their licensing states. Studies in both the laboratory and the field have validated the feasibility of distributing and delivering vaccines in a CTC (outside the traditional 2°C to 8°C range) for limited periods of time, under monitored and controlled conditions, as appropriate to the stability of the antigen. This approach—which has been

ContentsMenAfriVac™ planned for use in a controlled temperature chain . . . . . . . . . . . . . . . . . . . . . . . . 1

Global Vaccine Action Plan to receive endorsement at World Health Assembly . . . . . . . . . . . . . 3

wVSSM goes online in Tunisia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Assessing the benefits of regional distribution centers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Do battery-free solar refrigerators work in low-light conditions? . . . . . . . . . . . . . . . . . . . . . . . . . 8

In Pictures: Installing and testing battery-free solar refrigerators in Vietnam. . . . . . . . . . . . . . . 10

Announcements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

Resources. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

MenAfriVac is a trademark of Serum Institute of India Ltd.

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used successfully for both heat-stable vaccines such as hepatitis B and those with a lower stability profile such as the oral polio vaccine—is now being explored for MenAfriVac.

Unpublished data obtained from the vaccine manufacturer show that MenAfriVac has proven stable at temperatures of 40°C for limited periods of time. This indicates that the vaccine could be safely distributed outside of the 2°C to 8°C range for a specific period under controlled conditions during campaign activities. The data are currently being reviewed and Serum Institute of India plans to formally submit the request for a MenAfriVac license variation within the next few months.

In addition to supporting the license variation for MenAfriVac, project Optimize is also working with its partners in other areas to ensure that the re-licensed vaccine can be safely distributed in a CTC. Firstly, Optimize is conducting a detailed analytical study of the benefits of using a CTC in immunization campaigns. Drawing on cold chain campaign costing studies conducted in Chad and Ghana in 2011, the analysis will investigate the potential cost savings and other benefits of using a CTC for the remaining MenAfriVac campaigns.

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Just a few of the ice packs needed for a measles campaign in Ghana, 2010.

A child is vaccinated with MenAfriVac in Burkina Faso, December 2010.

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The potential benefits of distributing vaccines in a CTC are compelling. Preliminary studies have shown that it has the potential to reduce costs and demand on human resources, and can increase flexibility in vaccination strategy design and coverage potential. However, the logistical challenges of implementing this new distribution model are considerable, and many issues still need to be resolved. For example, the training necessary to implement CTC for campaigns has not yet been fully defined. To address this, Optimize is working with a sub-group of WHO’s Immunization Practices Advisory Committee (IPAC) to formulate operational guidance on how to distribute MenAfriVac in a CTC. It is hoped that this guidance will be endorsed by IPAC later this year. A pilot scheme being planned with the WHO Regional Office for Africa will allow for field validation and revision of the operational guidance as needed.

Another issue that needs to be resolved is whether vaccines that have been exposed to a CTC can be safely returned to the cold chain. Serum Institute of India is conducting tests to find an answer, and their findings will—once assessed by regulators—guide how MenAfriVac can be distributed in a CTC.

Realizing the benefits of a CTC may have implications for how vaccines are developed and delivered across the globe. Obtaining a license variation for MenAfriVac will allow countries to distribute the vaccine outside the traditional 2°C to 8°C range, which could help to define a regulatory pathway and operational guidance for the distribution of other vaccines outside this narrow range.

Global Vaccine Action Plan to receive endorsement at World Health Assemblyby Magda Robert and Laurie Werner, Decade of Vaccines Collaboration

Over the past year, the Decade of Vaccines (DoV) Collaboration has been developing a Global Vaccine Action Plan (GVAP). The plan is now being finalized and will be presented for endorsement at the 65th World Health Assembly, to be held in Geneva on May 21–26, 2012. One of the recommendations made is the need to improve immunization delivery systems, and the importance of innovation in achieving this.

The GVAP outlines how best to provide lifesaving vaccines to those who need them most, how to maintain a strong pipeline of new vaccines, and how to strengthen public support for vaccination efforts. By 2020, the plan aims to meet the following goals:

• Achieve a world free of polio.

• Meet global and regional elimination targets.

• Meet vaccination coverage targets in every region, country, and community.

• Develop and introduce new and improved vaccines and technologies.

• Exceed the MDG 4 target for reduction in child mortality.

The GVAP proposes that these ambitious goals be met through six strategic objectives:

1. All countries commit to immunization as a priority.

2. Individuals and communities understand the value of vaccines and demand immunization as both their right and responsibility.

3. The benefits of immunization are equitably extended to all people.

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4. Strong immunization systems are an integral part of a well-functioning health system.

5. Immunization programmes have sustainable access to predictable funding, quality supply, and innovative technologies.

6. Country, regional, and global research & development (R&D) innovations maximize the benefits of immunization.

For those working in the field of vaccine supply chains, strategic objective 4 is particularly important, as it emphasizes the importance of innovation in the supply chain. Establishing and improving information systems, cold chain capacity and logistics, and waste management is also highlighted as critical for the next decade.

The GVAP was initially developed through the work of stakeholders across the immunization spectrum, with input from eight working groups composed of more than 100 core members. Starting in November 2011, the DoV Collaboration shared the draft GVAP with stakeholders around the world. Over the ensuing months, the DoV Collaboration held approximately 20 consultations with stakeholders in Asia, Africa, the Americas, Europe, the Middle East, and Western Pacific regions.

Overall, more than 1,100 stakeholders from the working groups and global consultation process, representing more than 140 countries and 290 organizations, provided ideas, feedback, and comments on the GVAP. They represented governments, policymakers, elected officials, civil society, health professionals, global development organizations, the research community, manufacturers, and other experts.

Dr. Ciro de Quadros (DoV Collaboration Steering Committee Co-chair), Salomon Chertorivski (Minister of Health of Mexico), Dr. Phillippe Lamy (Pan American Health Organization/World Health Organization Representative in Mexico), and Dr. Jean-Marie Okwo-Bele (Director, World Health Organization Department of Immunization, Vaccines and Biologicals) discuss the importance of immunization during the closing panel at the Americas regional consultation in Mexico City, February 2012.

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Emerging from the consultation process, certain critical components of the World Health Organization/UNICEF Global Immunization Vision and Strategy have been given greater emphasis in the GVAP. This includes amplifying the emphasis on country ownership, generating demand for immunization, having a comprehensive strategy for vaccination (from research and development to delivery, access, and public and political support), and strengthening comprehensive disease prevention and control. The GVAP also proposes:

• A high-level monitoring and evaluation framework with defined indicators and stakeholder responsibilities.

• Innovation as a guiding principle.

• Recasting the Reaching Every District strategic approach as “Reaching Every Community.”

• Adding supply-side interventions to ensure sustainable access to vaccines.

• Broader stakeholder participation in the planning and implementation process, including a larger group of actors from across the immunization spectrum.

We hope the GVAP will be endorsed by the World Health Assembly in May. Once endorsed, we will have a plan that looks at the discovery, development, and delivery of immunization, and provides a strategy for country ownership, demand generation, equity, health systems strengthening, financing, supply, and research and development that needs to be translated at the regional and country levels. It will also set the foundation for a monitoring and evaluation framework for implementation of the plan over the decade.

We now have a strategy for the next ten years and, once approved, the decade-long task of implementing such an ambitious plan will begin.

For more information on the DoV Collaboration, visit the DoV Collaboration website or email Laurie Werner (lwerner@path.org).

wVSSM goes online in Tunisiaby Mojtaba Haghgou, consultant, and Ramzi Ouichi, WHO

A web-based version of the Vaccination Supply Stock Management (VSSM) tool has been successfully deployed in Iran. Now, project Optimize is collaborating with the Tunisian Ministry of Health to field-test wVSSM in Tunisia.

VSSM is an open-source software application developed by the World Health Organization (WHO) to enable immunization program managers and vaccine store staff to manage vaccines and related supplies. It is based on existing WHO and UNICEF policies on vaccine management, with consideration for common field practices in developing countries. Although the focus is on vaccines, the application can be used to manage health supplies, particularly those provided through primary health care services. First deployed in 2006, VSSM is now available in ten different languages and used by immunization programs in more than twenty countries.

The web-based version of VSSM, named wVSSM, has all the features of the standalone version. Being web-based, wVSSM is simple to use and easy to access. Inventory data are stored on a central server that can be viewed by anyone with a wVSSM account, a computer, and a working Internet connection. Once connected, staff can view the total current stock of any item up to the country level.

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In 2009, the Iranian Ministry of Health and Medical Education deployed VSSM in the national vaccine store and three regional stores. In early 2011, Iran moved from VSSM to wVSSM, starting at the national level and then going to the regional, provincial, and district levels. Today, all 6 regional, 46 provincial, and approximately 350 district stores in Iran are connected to wVSSM, and all vaccine stock management is done with wVSSM. (wVSSM has not been deployed below the district level).

In November 2011, in collaboration with project Optimize, the Tunisian Ministry of Health began field-testing wVSSM in Tunisia. The goal of this testing was to demonstrate the benefits of moving away from a paper-based system to a computerized, networked information system that links national, regional, district, and health center levels. This will enable the exchange of real-time data on vaccine forecasting, stock management, and order status information, ensuring that the right quantities are distributed to the right place at the right time. It is expected that this ability to track and trace vaccines throughout the supply chain will reduce the risks of overstocking, expiry, and high vaccine wastage. As Tunisia begins to introduce new and more expensive vaccines, reducing these risks is becoming increasingly important.

Although wVSSM is a comprehensive stock management solution, some modifications were needed to accommodate the local context in Tunisia. In particular, some Arabic and French text was modified to make it more easily understood by Tunisians. Relevant forms for ordering vaccines also needed to be added.

Once the wVSSM tool was updated for use in Tunisia, over the course of 2011, the team conducted a series of induction and refresher workshops. In parallel with the training activities, the required computer hardware was purchased and installed. A wVSSM server was set up at the Informatics Centre of the Tunisian Ministry of Health in Tunis, and IT equipment such as computers and printers were installed at the ten pilot sites selected to use wVSSM. The team also worked to ensure that the pilot sites had the Internet connectivity required to communicate with the wVSSM server.

In the three months since field-testing began, moving from a paper-based system to a computerized one has worked well, and health workers are pleased with the change. Currently, the national, regional, and district levels of the system have all been linked, and complete stock management information for vaccines can be seen in real time at each level.

Although the initial experience has been positive, it has not been free of challenges. Without a reliable Internet connection, wVSSM cannot function. In the more remote areas of Tunisia, where connectivity cannot be guaranteed, this has made it difficult for health workers to use the new system. It has also taken time for health workers to adapt to the new tool.

A demonstration version of wVSSM is available online. Contact Mojtaba Haghgou (mojtaba@wvssm-demo.com) to receive a username and password.

District health workers in Tunisia using wVSSM to prepare orders for vaccine dispatches to health centers.

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Assessing the benefits of regional distribution centersby Kristina Lorenson, PATH

Regional distribution centers (RDCs) may be a realistic option for countries that distribute large quantities of vaccines and need to invest in cold chain infrastructure, according to a report by project Optimize. The report, completed this month, assesses the cost of using an RDC, or intercountry warehouse, for the storage and distribution of vaccines for multiple countries in a single geographic region.

Over the last decade, interest in vaccine development has increased dramatically. As a result, the number of World Health Organization-prequalified vaccines has almost tripled during this time. Given the large investments in research and development by manufacturers, new vaccines are priced higher and are often presented in single- or two-dose vials to minimize vaccine wastage. Countries are therefore facing the challenge of maintaining cost-effective, high-quality supply chains as more temperature-sensitive products that are priced higher and packaged in larger unit volumes are introduced.

Given the significant investment that countries may need to make as new vaccines are introduced, alternative options for the timely, cost-effective, safe delivery of vaccines are under evaluation. The report by project Optimize focuses on a specific supply chain strategy—the feasibility of leveraging an RDC model for vaccine distribution. It outlines the economic issues that need to be addressed for such a solution to be acceptable to country decision-makers, vaccine manufacturers, and private-sector warehouse and distribution companies.

Typically, an RDC organizes the shipment of vaccine products directly from manufacturers, stores these products in a central warehouse, and distributes them to countries as needed. By servicing multiple countries, an RDC would ideally be able to gain cost savings throughout the supply chain by generating economies of scale with regional consolidation and increased volumes of vaccines. The proximity of vaccine inventories to client countries would enable countries to increase the frequency of vaccine distribution to central or directly to second-level vaccine stores, aiding in inventory management and subsequently minimizing stockouts and wastage rates. In addition, leveraging an RDC could reduce the cold storage and transport investment requirements of individual countries.

The countries included in the Optimize study are Botswana, Malawi, Mozambique, Namibia, South Africa, Zambia, and Zimbabwe. This region was selected because it currently leverages an RDC model under the US President’s Emergency Plan for AIDS Relief for distributing HIV commodities and other pharmaceuticals and vaccine products for the private sector. The region also includes a diverse sample of countries with varying population sizes, income levels, and immunization coverage rates. The assessment, conducted via a series of interviews, involved stakeholders representing manufacturers, immunization program managers, other Ministry of Health personnel, existing RDC managers, and the UNICEF Supply Division.

To assess the potential cost of an RDC, an economic model was developed to test three different vaccine adoption scenarios for each of the seven countries between 2010 and 2020. While it would be ideal to model the potential reduction in wastage, freight damage, and vaccine security, data limitations required the model to compare only distribution costs—shipping and transport costs, handling and management fees, and cold chain infrastructure—between existing distribution and a potential RDC distribution model.

Four of the seven countries in the study were interviewed. Of the four, three had facility and transportation cold chain constraints from the provincial or district level down and one country had constraints at the central level and down. The initial assumption of the assessment model was that the RDC would take the place of a country’s central warehouse, saving governments from potentially large investments in

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cold chain equipment. However, several of the central warehouses in countries in the African region had recently been upgraded through funding provided by the USAID Supply Chain Management Systems project; thus, the potential savings impact of an RDC in such countries was not as significant.

The economic model shows that an RDC may be attractive to countries distributing large volumes of vaccines and needing to invest in additional cold chain infrastructure to meet future vaccine requirements. However, there are other situations where an RDC may be less attractive. For example, if management and distribution pricing is the same across all participating countries, the RDC may not be economically attractive for smaller countries that distribute smaller volumes of vaccines.

As the volume and value of vaccines increase over the next decade, handling and distribution costs will increase dramatically; those countries that have not already committed to investing in cold chain infrastructure may, therefore, be best positioned to consider leveraging an RDC for vaccine distribution.

To request a copy of the Optimize report, please email project Optimize (optimize.who@path.org).

Do battery-free solar refrigerators work in low-light conditions?by Joanie Robertson, PATH, and Steve McCarney, Solar Electric Light Fund

Field-tests conducted in the cloudy north of Vietnam suggest there may be a bright future for battery-free solar refrigerators in low-light conditions.

As reported in the Op.ti.mize October 2011 issue, project Optimize is collaborating with Vietnam’s National Expanded Programme on Immunization to evaluate the effectiveness of battery-free solar-powered vaccine refrigerators. One of the key questions being asked is, how well do these refrigerators perform under relatively poor solar conditions?

For years, solar refrigeration has helped developing countries to increase their cold chain capacity while decreasing energy costs and consumption. However, problems with battery maintenance and cost have made solar refrigeration a challenge. To address these problems, manufacturers have created a new type of refrigerator that eliminates the need for a battery. But without a battery to store solar energy, how can solar refrigerators continue to keep cool in low-light conditions?

“Insolation” refers to incoming solar radiation at a particular time and place. If a location is typically cloudy for long periods, then it would be said to have low insolation, and would not usually be considered an appropriate location for solar-powered equipment. We decided to test this assumption with the True Energy BLF 100 DC Sure Chill® vaccine refrigerator.

Periods of low insolation are commonly encountered from December to February in northern Vietnam, which can often go for several weeks without a sunny day. However, in the sunnier south of the country, year-round high insolation is more common. We installed and evaluated the Sure Chill vaccine refrigerator in both parts of the country—Phu Tho province in the north, and Ben Tre province in the south.

The Sure Chill vaccine refrigerator installed in northern Vietnam showed constant temperature performance into mid-February 2012. This was particularly impressive as the period being measured included 15 consecutive cloudy days. Figure 1 charts the daily insolation values in this critical time frame of very low-light conditions.

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Figure 1. Daily insolation during three winter weeks in northern and southern Vietnam

The insolation for this entire period trends below the average daily insolation of 3.0 kWh/m2 for the full monitoring period from May 2011 to February 2012. For comparison, the data from the site in the sunnier south of Vietnam are also charted, along with the average daily insolation there of 5.0 kWh/m2 from October 2011 to February 2012.

From December 23, 2011 to February 14, 2012, the refrigerator in the south performed well, as expected given the good solar conditions. But how well did the vaccine refrigerator in the cloudy north of the country perform during this period? The data show that the temperature in the middle of the refrigerator was maintained at a steady average of 4.4°C with no excursions to less than 3.9°C or greater than 7.0°C. Perfect performance.

You may wonder how the Sure Chill vaccine refrigerator can cope so well under these conditions. First of all, it should be noted that the cloudy conditions in northern Vietnam correspond with generally cool ambient temperatures. From December 23, 2011 to February 14, 2012, the ambient temperature in the room where the refrigerator was located averaged around 17°C, with a minimum of 15°C and a maximum of 21°C. Compare these temperatures to the summer temperatures from May 12, 2011 (when monitoring started) to September 30, 2011. During this time, inside ambient temperatures ranged from 26°C to 32°C, with an average of 30°C. In effect, the vaccine refrigerator did not need to work as hard to keep cool in the winter.

Another design feature that seems to serve this technology well is the low starting voltage. The Sure Chill vaccine refrigerator uses a specially designed compressor that requires a lower voltage to start than some other refrigerators, so it can start earlier in the morning and continue until later in the day, when the solar energy is still low. During cloudy days, the compressor is able to start with the small amount of solar energy coming through the clouds, whereas another system might never have enough energy to get going.

The thermal storage system of the Sure Chill vaccine refrigerator has been shown to have adequate capacity to cover a long period of low energy input. (“Thermal storage” refers to the frozen liquid that

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Average daily insolation in south Vietnam, 10/2011 to 02/2012

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is generally used in battery-free refrigerators to store energy for cooling, in place of the battery used in traditional solar systems.) These results indicate that battery-free solar refrigerators could be reliably placed in more locations than previously thought, and that batteries are not necessarily the only way to manage low-insolation conditions for vaccine refrigerators. This may be good news for immunization programs in many countries.

Optimize will publish an evaluation of the battery-free solar refrigerator testing in Vietnam later this year. For more information, please email Joanie Robertson (jrobertson@path.org).

In Pictures: Installing and testing battery-free solar refrigerators in Vietnamby Hai Le and Kien Vu, PATH

To accompany the article “Do battery-free solar refrigerators work in low-light conditions?” in this month’s newsletter, Optimize has published a photo set on Flickr that reveals how the solar refrigerators were installed and tested.

The photo set includes photographs of the installation and initial testing of two True Energy BLF 100 DC Sure Chill® vaccine refrigerators in Vietnam. The first vaccine refrigerator was installed in Phu Tho province in the north of Vietnam, while the second was installed in Ben Tre province in the south.

Access the photo slideshow directly.

Preliminary testing of the battery-free solar refrigerator included filling it with mineral water bottles to simulate vaccines and monitoring the temperature.

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OptimizeBatiment Avant Centre, 13 chemin du LevantFerney Voltaire 01210 FRANCE+33.450.28.43.75 | technet21.orgwho.int/immunization_delivery | path.org/vaccine-delivery.php

AnnouncementsNew funding opportunity: Seeking innovation to strengthen immunization systems

The Grand Challenges Explorations program is seeking bold ideas from innovative thinkers by offering US$100,000 grants to prove the potential of new approaches to optimize immunization systems. Priority areas for funding include: vaccine product characteristics, supply system design, environmental impact, information systems, human resources, and vaccination acceptance.

Great ideas can come from anyone, anywhere. Launched in 2008, Grand Challenges Explorations grants have already been awarded to 602 researchers in 44 countries.

The deadline for submissions is May 15, 2012. For more information, visit the Grand Challenges Explorations website or email GCEhelp@gatesfoundation.org.

View the announcement in full, or see our tips and tricks for developing strong submissions.

World Immunization Week 2012

This year, World Immunization Week takes place April 21–28, with the slogan “Protect your world, get vaccinated” under the overall theme of “Immunization saves lives.” This worldwide event is an opportunity to underscore the importance of immunization in saving lives and to encourage families to vaccinate their children against deadly diseases.

Immunization Week and the activities being organized this year.

Find out more about World Immunization Week and the activities being organized this year.

ResourcesNavigating WHO Product Decision-making: Vaccines

This navigation guide is designed to help orient product developers to the players and processes involved in product-related decision-making relating to vaccines at the World Health Organization. Contains detailed information on why specific groups and processes are important, how they operate, how they interact with one another, and where to look for more information.