Data Dive: What will it take to build an African medicines industry?

Around 99% of vaccines administered in Africa are produced outside the continent. This became a real problem during COVID-19, when rich countries monopolized the majority of vaccines. In response the African Union set a target of producing 60% of its own vaccines by 2040.

Scaling up African manufacturing capacity is crucial not only in the fight against COVID-19, but also for the development and roll out of vaccinations against other diseases, such as malaria, HIV and any future diseases.

It is also an economic and job creation strategy. The US pharma industry earned $425 billion in 2020, making up 3.2% of GDP. In the EU, the industry is worth $282 billion. By 2040, the industry in Africa could be worth $17 billion a year.

But what are the steps needed to make this a reality? This data dive maps out the challenge and the opportunity.

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    Key Facts

    • 2x: Africa has nearly twice the disease burden per capita compared to the rest of the world.
    • 99%: African imports 99% of the vaccines administered.
    • 25%: Percent of the world’s total vaccine doses used by sub-Saharan Africa
    • 5: Number of African countries that have the facilities to produce vaccines — Egypt, Morocco, Senegal, South Africa, and Tunisia.
    • $3 billion – $17 billion: The potential worth of the 2040 African vaccine market.

    Why dispersing vaccine manufacturing matters

    Four multinational manufacturers (GSK, Pfizer, Sanofi Pasteur, and Merck) represent 80% of revenues from global vaccines sales. Production is highly concentrated in Europe and North America.

    Global vaccine production is concentrated in wealthier regions

    Unequal distribution of vaccine production sites has coincides with inequitable access to vaccines.

    When COVID-19 vaccines became available, the lack of vaccine manufacturing in Africa became a problem as rich countries bought up supply contracts.

    The African Union’s Vaccine Acquisition Trust (AVAT) raised finance with support of the World Bank and Afrexim bank, but were initially unable to purchase vaccines because other countries had secured all the supply.

    COVAX, the mechanism designed to secure enough supply for low- and middle-income countries, contracted the majority of its supply with India’s Serum Institute.

    When the pandemic hit India hard in April 2021, the country imposed an export ban on vaccines, meaning vaccines that were promised in 2021 were not delivered.

    The lack of adequate production left the continent at the mercy of other countries’ export restrictions.

    But this isn’t just about the COVID-19 response.

    Response to current diseases and resilience to future pandemics will require vaccination production in all regions of the world.

    With mRNA technology rapidly accelerating the speed of vaccine development, the capability to produce these vaccines locally could save millions of lives, especially with vaccines for TB, malaria, and HIV in late stage development.

    Local production in Africa: The current state of play

    The African Union mandated the Partnership for African Vaccine Manufacturing (PAVM) to implement a 20-year plan for producing 60% of Africa’s vaccine demand by 2040. In the long term, this could also include therapeutics and diagnostics.

    The $30 billion plan aims to create 23 manufacturing plants with capacity to sustainably manufacture medical tools for some of the region’s leading causes of illness, including hepatitis B, diphtheria, human papillomavirus (HPV), malaria, and influenza. These plants include fill and finish (filling vials and packaging the medicine) and manufacturing of the drug substances.

    Moderna, BioNTech, and entrepreneurs, such as South African-born US biotech billionaire Patrik Soon-Shiong, have announced deals in support of the plan. They are at early stages, but aim to produce around 100 million to 400 million doses of COVID-19 vaccines in 2022.

    Only Aspen managed the end-stage production of millions of J&J vaccines in 2021. But Aspen received widespread criticism when it forced the South African government to deliver doses to Europe before serving African markets at a time when only 7% of South Africans were vaccinated.

    BioNTech’s modular containers are able to produce vaccines in shipping containers. BioNTech have been praised for the innovative approach that allows rapid scale up, but they have also been criticized for attempting to create a regional monopoly by sidestepping knowledge and technology transfer to African manufacturers. Similar criticism is made of Moderna’s announced facility in Kenya.

    African manufacturers have also taken things into their own hands, with some notable success:

    Still, it will take African countries some time before they can deliver safely manufactured and approved vaccines.

    In the absence of technology transfer and removal of intellectual property (IP) barriers, African manufacturers will have to repeat clinical trials processes for existing vaccines, grapple with the complexity of the vaccine making process, fulfil regulatory requirements, and overcome market access hurdles.

    Without a waiver on intellectual property, suitable licensing or commitment, it is unclear whether patents would be enforced on the relevant technology and products in the future.

    Creating a market for vaccines and countermeasures in Africa

    Critics of the plan point to the fact that supply of COVID-19 vaccines to Africa has ramped up since early 2022; but demand for vaccines has decreased.

    Several factors are contributing to decreased demand, including: mistrust in vaccines, fuelled by disinformation; the lack of a detailed and coherent strategy for generating demand for locally produced vaccines, especially for countries that are not subsidized or supported by Gavi; and weak investments in manufacturing capacity by African governments.

    Yet, these are short-term challenges that can be addressed, rather than reasons not to invest for the long term — not least because inequitable access to vaccines is now being replicated for treatments and other countermeasures.

    Vaccine manufacturers located in developing countries tend to be more receptive than large multinational corporations to focus on neglected diseases, especially when those diseases remain endemic in their country or region. For example, Bio Farma in Indonesia is now the sole developer of several oral polio vaccines used around the world, even as large multinational vaccine companies have stopped making them.

    Africa is home to many infectious diseases, and will need quick, affordable access to a suite of medical tools to fight these diseases with countermeasures based on local needs. Local manufacturing can also drive down costs while creating jobs and a broader economic footprint. The AU’s strategy could add $6 billion to the continent’s GDP and create 12,500 jobs by 2040.

    Overcoming barriers to success

    Intellectual property and the lack of technology transfer will mean repeated clinical trials and unnecessary struggles over the vaccine making process, regulatory requirements, and market access hurdles.

    To overcome current challenges and benefit from locally produced medical tools, a clear strategy is needed, now. Such a strategy should consider the following:

    Focus on technology, not just a disease

    Efforts to scale up should guarantee sustainability and aim to have the broadest possible impact on health, by not just focusing on one disease but developing technologies, for legacy diseases (hepatitis B, yellow fever), outbreak diseases (Ebola, influenza) and expanding diseases (malaria, COVID-19).

    mRNA technology offers high yield at small scale and low costs, while technologies that target specific outbreak diseases can make the African market more attractive for global investors.

    Build regional capacity

    Most African countries are not large enough to justify a dedicated vaccine manufacturing facility for domestic use. A few designated regional hubs could therefore serve the population of Africa as well as other regions. Current operations that could be scaled up include Senegal’s Institute Pasteur of Dakar (IPD), which currently produces yellow fever vaccines and is the only manufacturer that has capacity to produce WHO prequalified vaccines in Africa; South Africa’s Biovac, which has experience across the full vaccine value chain; and Nigeria’s CACOVID coalition, which funds research and diagnostics.

    Technology transfer at scale

    South Africa’s mRNA technology transfer hub aims to establish technology transfer at an industrial scale by delivering to multiple existing and new developing country manufacturers while promoting research and development, developing regulatory capabilities and upskilling workforce. Fifteen countries have been selected as recipients of the mRNA technology from the hub, six of which are located in Africa.

    The European Commission, MasterCard Foundation, and other donors have supported the hub’s ~€103 million annual budget (2021-2026) period — although an additional $20 million is still needed. Pharmaceutical companies should work to share COVID-19 data, know-how, and technology with the hub, as well as with the WHO’s COVID-19 Technology Access Pool.

    Sustainable financing and demand certainty

    Manufacturing capacity only makes sense if there are guaranteed buyers for the products. Africa-led pooled procurement through the African Vaccine Acquisition Task Trust (AVAT) could solve this problem.

    A feasibility study, which modeled capacity, volume, and scale against financing needs, estimates that the total cost for an “ideal” modular facility could cost $70 to deliver 21 million doses per year, sufficient for regional supply. A $138 million facility could supply almost the whole African market with one single antigen vaccine. A similar exercise is needed for different types of facilities, in order to build an investment case.

    Success stories

    In 2010, African leaders called for the eradication of group A meningitis epidemics in Africa, which led to the Meningitis Vaccine Project (MVP).

    This global collaboration between public health officials, the World Health Organisation, NGOs, and private companies developed an affordable, tailor-made vaccine called “MenAfriVac.”

    Technology transfer, regulatory approval, and testing enabled MenAfriVac to launch mass vaccination campaigns that dramatically reduced meningitis A.

    Global collaboration,technology transfer to local actors, and strong political will were all crucial factors in MenAfriVac’s success. A similar approach, where African production capacity benefits from global knowledge and technology transfer, could go a long way in producing medical tools locally.

    What needs to happen next?

    Global actors should continue to support the African Union’s goal of reaching a 60% production rate by 2040 in a sustainable environment. The 2022 G7 Leaders’ Communique expresses support for expanding manufacturing capacity in developing countries. Verbal support should be followed up with concrete actions. G7 and G20 leaders could take the following steps could help materialize this goal:

    Technology transfer at scale to accelerate production capacity by

    • Contributing to the additional €20 million required by the mRNA manufacturing hub in South Africa;
    • Committing to share vaccine, therapeutic and diagnostic technologies with the WHO technology transfer hub, Medicines Patent Pool and WHO C-TAP.

    Collaboration on market strategy to stimulate demand certainty by

    • Encouraging stakeholders like Gavi and the Global Fund to develop a market shaping plan by 2024 that outlines how their purchasing power can support a viable market for safe, effective, and affordable vaccines in Africa.
    • Collaborating with AVAT and regional development banks to ensure a viable, regional pooled procurement mechanism exists for locally produced medical tools.

    How can I learn more and stay informed?

    ONE’s Africa COVID-19 Tracker provides the latest reliable figures, commentary, and analysis on the health, economic, and social impacts of the pandemic on the continent. Sign up for our weekly email and follow @ONEAftershocks.