RoundTable 4: Supply Chain and Cold Chain Management of Vaccines – Summary Report

THE AfCFTA AND TRANSFORMATIVE INDUSTRIALISATION ROUND TABLESERIES ROUNDTABLE SERIES

ROUNDTABLE 4: SUPPLY CHAIN & COLD CHAIN MANAGEMENT OF VACCINES SUMMARY REPORT 2023 Cape Town

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Contents 1. Background.................................................................................................................................. 2 1.1

Objectives...................................................................................................................... 5

1.2

Speaker Biographies.................................................................................................... 5

2. Presentations............................................................................................................................... 6 2.1

COVID-19 Pandemic: A Lesson in Cold Chain Management................................ 6

2.2

Case Study: Cryo-Vacc®............................................................................................... 8

3. Conclusion.................................................................................................................................. 10 4. References....................................................................................................................................11

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The Nelson Mandela School of Public Governance at the University of Cape Town (UCT) hosted a webinar titled ‘Vaccine Value Chains – Challenges & Opportunities in Supply Chain and Cold Chain Management of Vaccines on 8 February 2023. This webinar was part of The School’s African Continental Free Trade Area (AfCFTA) and Transformative Industrialisation Webinar Series. Panellists were invited to share their perspectives on supply chain and cold chain management in Africa. These aspects of the pharmaceutical value chain came into sharp focus during the COVID-19 pandemic, as distributing vaccines to patients was a key challenge for many African countries.

1. Background During the pandemic, African countries were plagued with several supply chain issues, some of which were created due to the globalisation of pharmaceutical and vaccine manufacturing resulting in external dependencies within the vaccine manufacturing value chain. For example, many African countries depend on imports of production inputs for vaccine manufacturing. Other supply chain issues arose due to a lack of infrastructure to adequately supply vaccines to local markets in a manner that would maintain the integrity of the vaccines until they reached the patients. The latter was not a problem that was limited to Africa but was also specific to the attributes of the vaccines being developed and distributed.

For example, the Pfizer vaccine needed to be stored and distributed at extremely low temperatures; most developing countries did not have the infrastructure to accommodate such specifications (Marani, 2021).

In addition to these technical challenges, broader infrastructure challenges relating to the location of patients have to be taken into consideration. In this regard, the rural-urban divide proved to be a significant obstacle, especially where adequate transportation links were non-existent.

This made it extremely difficult for patients to access healthcare services and facilities.

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Cold chain management is critical for transporting and supplying vaccines in warmer climates, such as in most regions of Africa. As such, temperature control must be managed throughout the supply chain to ensure the integrity of the vaccines at the point of patient administration. Refrigerators are critical tools for cold chain management and require an uninterrupted power supply. This is difficult to secure in many African markets as their local power supply is not always reliable – power cuts, a lack of access to reliable power sources, and a lack of power infrastructure are common in many African countries.

The WHO regional office in Africa surveyed 34 African countries in 2021 and recorded the following data on cold chain capacity challenges experienced on the continent (Asadu, 2021): • 31% (11 countries) have over 50% of districts with gaps in cold chain capacity.

• 29% (9 countries) have districts with 20–50% cold chain capacity gaps.

• 40% (14 countries) have districts with less than 20% cold chain capacity gaps.

Out of challenges, come the opportunities to innovate – Africa is no exception. For example, Renergen, a South African alternative energy investments company, developed Cryo-Vacc® in 2021, which uses liquid

Supply Chain & Cold Chain Management of Vaccines • SUMMARY REPORT

nitrogen to transport vaccines over land and liquid helium for air transport. These substances can thereafter be altered and modified to accommodate various vaccine storage requirements (Whitehouse, 2021) (Kaplan & Laing, 2005).

The Futures Report (2021), commissioned by the AfCFTA Secretariat, states that “African pharmaceutical manufacturers often have difficulties in forecasting demand, dealing with fluctuating costs, accessing finance and foreign exchange, sourcing locally manufactured ingredients, high transport costs and border delays, and managing their manufacturing pipeline.” Despite these challenges, the report also refers to “new opportunities” in the vaccine value chain, especially in the logis-

tics services sector (AfCFTA Secretariat, 2021). According to UNECA, these opportunities include: a) supply chain mapping to identify sources of vaccines and other critical medical goods; b) development of logistics and warehousing as a service to enable regional distribution & inventory holding; c) development of linkages with the agricultural sector for supply of pharmaceutical grade ingredients such as starch and sugar and to enhance cultivation and the production of medicinal plants; d) establishment of sustainable international cooperation to facilitate smooth operations of new vaccines (United Nations Economic Commission for Africa, 2022).

This is outlined in the diagram depicted in Figure 1 (see below).

Figure 1: Opportunities in the vaccine value chain (AfCFTA Secretariat, 2021)

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Supply Chain & Cold Chain Management of Vaccines • SUMMARY REPORT

1.1

Objectives

The primary purpose of convening this round table webinar was to outline Africa’s cold chain industry and showcase innovations that have already been developed to address vaccine transport challenges. In doing so, we endeavoured to address the following questions: • Historically, transporting medicines and other health commodities across borders has been challenging due to technical regulation challenges – how will the AfCFTA tackle this?

• What examples of best practices for supply chain management that leverage technology can be utilised in the African context?

• Share examples of cold chain management technologies that have specifically been developed for utilisation in the African context, such as ‘Cryo-Vacc®’.

• What else can be done to drive innovation and partnership in this space?

• What are the best practices in Africa’s cold chain management solutions that can be exported to the rest of the world?

1.2 Speaker Biographies Theano Kosmas is the Founder and Managing Partner of Strategnos Consulting, a management consultancy focused on implementing business and supply chain solutions. Since its inception in the year 2000, she has grown the company from a “one man” show to a team of professionally competent individuals. Theano strives to provide value-adding services and advice to her clients consistently. Strategnos is based in South Africa but has a footprint across Africa and other parts of the globe.

Prior to establishing Strategnos, Theano was the Technical Director at Adcock Ingram (1994-1997).

Gavin Hunter is responsible for sales at Renergen and ran the Cryo-Vacc business development, and was at the proverbial coalface in the vaccine roll-out in South Africa during the COVID-19 pandemic.

During this period he and his team oversaw the cold chain management of approximately 1 million doses of the Pfizer vaccine.

Renergen has since developed the ground-breaking Cryo-Vacc vaccine cooler which enables safe transportation of vaccines at extremely low temperatures without the need for an external electrical power source.

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2. Presentations 2.1 COVID-19 Pandemic: A Lesson in Cold Chain Management Theano Kosmas shared how the COVID-19 pandemic and the subsequent development of vaccines highlighted the need for effective cold chain management in developing regions, especially in Africa.

Of the new medicines coming onto the market, such as biologicals, vaccines and personalized medicine, approximately 49% require cold chain management, and this percentage is expected to increase in the coming years. Before the COVID-19 pandemic, most medicines needed storage and transport temperatures of between 2-8°C or less than 25°C. However, of the COVID-19 vaccines produced, approximately 69% could be stored and transported between 2-8°C, and the rest required temperatures between -15 to -25°C. A wide range of vehicles are used for medicine and vaccine transport, ranging from uninsulated to refrigerated and temperature-controlled vehicles. For air and sea medical freight, polystyrene and polyurethane components are used to transport medicines and vaccines safely.

To ensure supply chain integrity, all areas of the medicine or vaccine supply chain have to be validated, and temperature monitoring equipment must be verified. It is imperative that all elements, equipment, and infrastructure must meet internationally accepted standards to ensure product integrity at the point of use. These standards differ based on the product and geographical location to compensate for local climate conditions.

The World Bank Logistics Performance Index (LPI) is an interactive benchmarking tool that assists in identifying challenges

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and opportunities that countries face in their performance on trade logistics. The 2023 LPI measured the speed of trade for the first time, using indicators derived from big datasets tracking shipments across 139 countries. For LPI rankings in 2023, top-scoring countries are concentrated in Europe, although East Asia and Pacific, North America, Middle East and North Africa are also represented. The average dwell time for containers between May and October 2022 was three days for India and Singapore, and four days for the United Arab Emirates and South Africa. On the other hand, the average for the United States was seven days and ten days for Germany. The LPI 2023 rated South Africa at 3.7 on a scale of 1-5; five being the maximum rating. Comparatively, Germany’s rating was 4.1 while the USA was rated at 3.8.

In 2015, the Ebola vaccine clinical trial conducted in Sierra Leone required vaccines to be stored between -60°C and -80°C. However, the freezers available could not accommodate this temperature specification. Moreover, the unstable electricity supply and lack of monitoring equipment and transport also compounded the situation. To address some of these challenges, facilities were equipped with backup generators and human intervention was used for monitoring purposes.

It is imperative to understand the cost of equipment and compliance requirements for medicines and vaccines to ensure product integrity at the point of use. In many cases, domestic fridges are used in healthcare facilities, which is inadequate as they do not provide the required stringent temperature controls. In addition, some temperature monitoring equipment can be complex. Therefore, the supply chain needs to be as simple as possible.

Supply Chain & Cold Chain Management of Vaccines • SUMMARY REPORT

A study conducted by Strategnos across 17 facilities in Africa and funded by a multinational pharmaceutical company, showed an overall skills deficit in managing outages and temperature monitoring.

Equipment tested during the study failed validation requirements and validation processes. Where appropriate, facilities received assistance in getting monitoring equipment to be functional.

For supply chain efficiency, it is crucial to ensure that stock monitoring and demand planning are as accurate as possible through an integrated demand plan. Transport routes for medicines and vaccines need to be mapped beforehand to determine temperature variations along the way. These routes should be validated to ensure compliance with temperature requirements for specific medicines and vaccines and to ensure product integrity upon delivery at the point of use. Medicines and vaccines should reach the point of use, as soon as possible, emphasizing the need for appropriate and reliable transport infrastructure and investment in supply chain skills for local capacity development.

Under the AfCFTA, it is recommended that specific border posts be designated and profiled for the transport of medicines and vaccines, especially when considering the changing climate conditions. Investments will be required to ensure that the necessary infrastructure is in place at these border posts. A level of tolerance needs to be built into both vehicles used for transport as well as the packaging materials.

Where possible, existing packaging should be re-used to reduce cost and waste as long as the packaging material integrity remains intact in terms of temperature control.1 At present, the packaging is widely re-used in the public health sector, and therefore, it is important to monitor temperatures to ensure that required temperature control is adequately maintained.

1 There is less re-use of polystyrene packaging than polyurethane.

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2.2 Case Study: Cryo-Vacc® Gavin Hunter shared insights from Renergen’s journey in developing and commercialising Cryo-Vacc® for the storage and transport of vaccines. Cryo-Vacc® is an insulated vaccine chamber (independent of electricity) that circulates nitrogen (see

Figure 2: Cryo-Vacc® product characteristics

Figure 3: Cryo-Vacc® unit dimensions

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Figure 2). This is a significant development, especially for countries that do not have a reliable electricity supply (such as South Africa). The product is available in three sizes varying from 15kg to 25 kg; because of the light weight of the product, it is easy to transport (see Figure 3).

Supply Chain & Cold Chain Management of Vaccines • SUMMARY REPORT

During the development of Cryo-Vacc®, proof of concept was conducted for approximately 6-9 months, mainly in the Western Cape, which managed approximately 1 million doses of the COVID-19 vaccine. An additional study was conducted with the Western Cape Department of Health, which showed that with the use of Cryo-Vacc®, there was no need for external power, and costs were calculated to be approximately R830/day.

The initial vision for Cryo-Vacc® was to address the refrigeration needs of developing countries, especially at -80°C and below. The next development of Cryo-

Vacc® will focus on the transport of more specialised products such as stem cells, which require a temperature of -150°C. No specialised skills are required for installing and management of Cryo-Vacc®.

With the development of products such as Cryo-Vacc®, there is an opportunity for focused collaboration amongst industry and non-industry players. For instance, regulations and compliance requirements by the regulator for product registration and approval should not be a hurdle to bringing such innovations to market in the shortest possible time.

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3. Conclusion Supply chain and cold chain management for the safe storage and transport of medicines and vaccines remain challenging in Africa for several reasons. The challenges include a lack of appropriate infrastructure, intermittent power supply, and a lack of skills and understanding of compliance requirements to ensure product integrity at the point of use.

Considering the evolution and innovation towards more personalised medicines, most of which require stringent temperature controls, it is imperative to invest in appropriate infrastructure, systems and processes as well as skills to manage the healthcare supply chains in Africa. The AfCFTA allows opportunities for collaboration across multiple sectors to improve supply chain efficiencies.

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Applicable regulatory and compliance frameworks must be agile and forward-looking to deal with ongoing innovation in developing medicines, products, and devices to manage temperature control. Policymakers must factor these aspects into policy design and implementation so that product integrity is maintained throughout the supply chain.

Bespoke solutions such as Cryo-Vacc® amongst others, specifically designed for Africa’s unique environmental conditions, demonstrate that out of necessity, ground-breaking innovations can be developed. Ultimately for more solutions and tools for supply chain and cold chain management to be developed, innovation ecosystems in Africa need to be well-resourced and nurtured to produce solutions relevant to African challenges.

Supply Chain & Cold Chain Management of Vaccines • SUMMARY REPORT

4. References AfCFTA Secretariat, U. (2021). The futures report - Which value chains for a made in Africa revolution. (). Addis Ababa: https://www.africa.undp.org/ content/rba/en/home/library/reports/ futures-report-2021.html Asadu, C. (2021). As Africa awaits next Covid19 vaccine supplies, WHO survey shows cold chain gaps persist. The Africa Report.com. Retrieved Jun 8, 2022, from https://www.theafricareport. com/ 113056/as-africa-awaits-nextcovid-vaccine-supplies-who-surveyshows-cold-chain-gaps-persist/ Kaplan, W., & Laing, R. (2005). Local production of pharmaceuticals: industrial policy and access to medicines, an overview of key concepts, issues and opportunities for future research.

Marani, S. (2021). Inventive cold chain solutions for Africa. The Mail & Guardian. Retrieved Jun 7, 2022, from https:// mg.co.za/opinion/2021-08-18-inventivecold-chain-solutions-for-africa/ United Nations Economic Commission for Africa. (2022). Newsletter of the African Continental Free Trade Area-anchored Pharmaceutical Initiative - Issue 1. https://www.uneca.org/ afcfta-anchored-pharma-initiative/ newsletter-of-the-african-continental-free-trade-area-anchored. Retrieved Jul 3, 2023, from https://www.uneca. org/afcfta-anchored-pharma-initiative/ newsletter-of-the-african-continental-free-trade-area-anchored Whitehouse, D. (2021). South Africa: Renergen pioneers cold storage solution for coronavirus vaccine transport.

The Africa Report.com. Retrieved Jul 3, 2023, from https://www.theafricareport. com/94440/south-africa-renergen-pioneers-cold-storage-solution-for-coronavirus-vaccine-transport/

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