1. Background and Context

The Nelson Mandela School of Public Governance at the University of Cape Town, in partnership with the Centre for Competition, Regulation and Economic Development (CCRED) at the University of Johannesburg, launched the AfCFTA and Transformative Industrialisation series in 2020. The main objective of this series was to explore the potential of building regional value chains in pharmaceuticals, agriculture, textiles and clothing, to strengthen policy implementation of the AfCFTA.

In 2022, the Nelson Mandela School and its partners sought to make key policy and other actionable recommendations to develop regional value chains in the healthcare and pharmaceutical sector across Africa through leveraging opportunities presented by the implementation of the African Continental Free Trade Agreement (AfCFTA). To this end, a roundtable series on pharmaceutical manufacturing was curated for delivery in 2022.

Many organisations have raised the issues of vaccine equity and the lack of access to vaccines in Africa since the start of the pandemic. Ways to address this inequity, both to meet the needs of the continent during the current pandemic and to create a state of self-sufficiency and competitiveness through local manufacturing, have been debated. Varying solutions have been proposed, some of which will keep the African continent in a perpetual state of external dependency.

National and international responses to the Covid-19 pandemic have further exposed the global asymmetries in installed manufacturing capabilities and industrialization1. This inadequacy, as further revealed by the pandemic has renewed concerns and the genuine commitment to change the narrative of Africa’s lag in industrialization when compared with its peers2 . Pharmaceuticals are ranked the 4th highest category in terms of the value of imports to sub-Saharan Africa in 2018 (World Integrated Trade Solution), amounting to 70% - 90% of the total market in this region. In sharp contrast, the value of exports of pharmaceuticals in the same year was less than 10% of the value of imports3 .

An assessment of the vaccine manufacturing landscape in Africa reveals that the situation is dire in comparison to pharmaceuticals. Vaccine production in Africa is currently estimated at around one percent of the domestic need of the continent for routine immunization – this does not include needs for pandemic and outbreak control. There is limited accurate and up-to-date information on the status of existing vaccine manufacturing facilities in terms of their manufacturing capacity, sustainability in terms of business viability, compliance with required regulatory standards and their ability to ensure the security of supply.

In response to this critical and urgent need for vaccines, Heads of State from across the continent met to make a collective commitment of manufacturing at least 60% of Africa’s consumption of vaccines for routine immunization on the continent by 20404. This important task was delegated to the Africa Centres for Disease Control and Prevention (Africa CDC) who facilitated the inauguration of the Partnerships for Africa’s Vaccine Manufacturing (PAVM) in April 2021, together with the establishment of several technical task teams with experts from Africa.

Africa CDC’s PAVM initiative has motivated at least 9 countries on the continent to start (or plan) multiple initiatives towards expanding domestic manufacturing capacity on the continent, starting with Covid-19 vaccines through

1 Kumar A, Singh R, Kaur J, et al. (2021, November). Wuhan to World: The COVID-19 Pandemic. Front Cell Infect Microbiol. doi:10.3389/FCIMB.2021.596201/FULL 2 The African Continental Free Trade Area. Accessed March 10, 2022. https://www.worldbank.org/en/topic/trade/ publication/the-african-continental-free-trade-area 3 Banga et al., 2020; Conway et al. 2019; UNCTAD. 4 Africa-CDC. (2021). African Union and Africa CDC launches Partnerships for African Vaccine Manufacturing (PAVM), framework to achieve it and signs 2 MoUs. 12th and 13th April 2021. Africa Union-Africa CDC; Africa-CDC. 2021. Partnerships for African Vaccine Manufacturing in Africa (PAVM) –workshop with mRNA vaccine manufacturers and key players: Concept Note. Addis Ababa: Africa Union-Africa CDC.

the establishment of partnerships, and new manufacturing facilities or upgrading existing facilities. These countries include Algeria, Egypt, Ghana, Morocco, Nigeria, Rwanda, Senegal, South Africa and Uganda.

Some of these countries have taken the bold step to manufacture vaccines using newer technologies like the mRNA platform. Other initiatives include the development of novel vaccines using virus-like particle technology platforms.

In addition, the Africa CDC, World Health Organisation (WHO) and Covid-19 Vaccines Global Access (COVAX) have partnered with government and industry stakeholders to set up the first African Covid messenger RNA (mRNA) vaccine technology transfer hub in South Africa.

The PAVM initiative has focused mainly on the mRNA vaccines (Moderna and Pfizer/ BioNTech), and the adenovirus vector platform (AVV) vaccines developed by Johnson & Johnson5,6. These efforts have so far also focused predominantly on the latter part of the vaccine value chain, i.e. fill & finish, which is considered less complex but at the same time creates some level of vulnerability due to the ongoing dependence created by the need to import the drug substance or active for the vaccines.

In addition, due to the urgency of the pandemic and the need to optimize speed and quality, there is limited opportunity to source any of the production input materials required for the manufacturing of vaccines from local African sources due to stringent regulatory requirements. Changes in the source of production inputs or manufacturing process methods would require regulatory approval and, if significant, could require new clinical trials due to the potential clinical impact on patients.

Other initiatives within the PAVM framework, such as pathways for regulatory harmonisation, tech transfer & IP and R&D for vaccines to be produced in Africa will require the support of the AfCFTA Secretariat to create an enabling environment to establish optimized regional value chains for sustainable vaccines production.

Even though the pandemic has created a high level of momentum to develop local vaccine manufacturing capabilities with urgency, there is also a fair amount of scepticism around African countries’ capabilities to implement and maintain this level of manufacturing infrastructure. There is also the risk of duplication of effort and capabilities across countries which may become problematic in terms of access to markets to consider.

While the current efforts are nested in the global push for access to Covid-19 vaccines on the continent, a holistic, implementable strategy that is African-led is needed to ensure sustainable health security and self-sufficiency in the supply of critical health commodities to its populations.

5 The Johnson & Johnson vaccine is already being manufactured (fill and finish) by Aspen Pharmacare in South Africa 6 Slaoui, M. & Hepburn, M. (2020). Developing Safe and Effective Covid Vaccines — Operation Warp Speed’s Strategy and Approach. The New England Journal of Medicine. (383;18):1701-1703. https://www.nejm.org/doi/full/10.1056/NEJMp2027405.