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How continent is navigating decades-old obstacles to build robust vaccine industry
ANALYSIS | The African Union has embarked on one of its most audacious health security missions: Ensuring that the continent manufacture 60% of its own vaccines by 2040. It currently manufactures a lowly 1% of the vaccines. However, since April 2021, when the AU tasked the Africa Centres for Disease Control and Prevention (Africa CDC) to initiate a structure, technocrats have been busy pushing the dream. In the second of a four-part series, The Independent’s Ronald Musoke, looks at how partners are addressing some of the obstacles that have held back the continent from nurturing a robust vaccine manufacturing industry.
Africa’s push for a robust vaccine manufacturing sector has for long been hamstrung by, among others, inadequate human and technical skills, insufficient investment in research and development, global competition laws and policies, intellectual property rights laws, regulation shortfalls, poor capital markets, and high operation costs.
But challenges are meant to be conquered. Many experts in the optimistic corner argue that Africa’s age-old challenges can be subdued this time. The optimists are buoyed by current projections that point to a large African population that will swell even further over the coming decades and the many promising developments across the continent.
“We see promising developments on the continent and we’re looking at engaging with all the stakeholders to join forces with Africa CDC as we strive to achieve the AU’s ambition to manufacture 60% of vaccines needed by 2040,” Dr. Abebe Genetu Bayih, the Acting Lead, Platform for Harmonized African Health Products Manufacturing (PHAHM), at the Africa CDC, told The Independent recently in an email interview.
Charting roadmap for vaccine freedom
The last four years have seen a ramp-up in activity; with the African Union mandating the Africa CDC to chart a roadmap that is supposed to halt the dependence on imported vaccines by building a robust health system. This, in turn, is supposed to help Africa achieve the United Nations’ Sustainable Development Goals (SDG 3 on Good Health and Well-being, SDG 8 on Decent Work and Economic Growth), and SDG 9 on Industry, Innovation, and Infrastructure).
While vaccine manufacturing across the continent can broadly be described as nascent, if not stagnant, vaccine demand has been projected to more than double in volume over the next decade from 1 billion doses today to over 2.7billion doses in 2040. Still, experts say for local vaccine manufacturers to benefit from the expected demand, a number of obstinate challenges that have held back the industry will have to be tackled head-on.
“We need to build capacity, attract good scientists, attract funding, encourage tech transfer, work with Africa CDC and many others, including the World Health Organization (WHO), and the whole international community,” says Prof. Pontiano Kaleebu, the Director of the Uganda Virus Research Institute (UVRI), the oldest institution in the country that has been at the helm of vaccine research in eastern Africa for close to 90 years.
Dr Kaleebu was echoing sentiments Rangarirai Machemedze, the Coordinator of the Zimbabwean chapter of the Southern and Eastern Africa Trade Information and Negotiations Institute (SEATINI), made at a conference on “Advancing Regional Vaccine Manufacturing and Access in Africa,” hosted in the Ugandan lakeside town of Entebbe in June, 2023. Machemedze was presenting a paper: “Advancing Local Pharmaceutical Production through Legislation and Institutions Reform in the East and Southern Africa region.”
He said, in Africa, operational costs are often high because of very old (pharmaceutical) plants, skilled workers cannot be retained, tariffs on water and electricity are high, and working capital and technology are often lacking.
Nurturing partnerships
In another conference held six months later, still in Entebbe, on the same issue of vaccine manufacturing in Africa, Nazeem Mohamed, an international pharmaceutical consultant with over 40 years of experience told delegates that besides African pharmaceutical manufacturers requiring huge sums of capital to set up vaccine plants capable of producing 15 legacy vaccines, they would also need partnerships with bigger pharmaceutical industries in the West to share technology.
“That will not come cheaply,” he said. Under its Partnerships for African Vaccine Manufacturing (PAVM), the Africa CDC strategy highlights the need for stakeholders, including private sector actors, to support its vision, build sufficient human capital and skills, and raise finance for the vaccine manufacturing value chain on the continent.
The PAVM, for instance, is collaborating with public and private education and research institutions to develop skills. It is working closely with pilot facilities such as the MADIBA project in Dakar, Senegal.
The MADIBA or the “Manufacturing in Africa for Disease Immunization and Building Autonomy” project is a groundbreaking initiative spearheaded by the Institut Pasteur de Dakar (IPD) to advance vaccine manufacturing capacity in Africa. Named after South African statesman, Nelson Mandela (“Madiba”), the project embodies the spirit of African self-reliance and innovation, says Natasha Kofoworola Quist, a communications specialist at VaxSen, the commercial subsidiary of Institut Pasteur de Dakar.
She says the project is focused on developing and scaling up the production of affordable, high-quality vaccines for diseases that disproportionately affect Africa, such as yellow fever, measles, and COVID-19 by leveraging cutting-edge mRNA and other advanced vaccine production technologies.
“It involves collaborations with global stakeholders, including governments, multilateral organisations, and private sector partners, to share knowledge, resources, and expertise,” Quist told The Independent.
Access to finance
Over the last half-century, access to finance has been one of the most important factors that have blocked vaccine manufacturers across the continent from running successful pharmaceutical manufacturing ventures.
In spite of current enthusiasm, building manufacturing capacity in African still faces the challenge of securing low-cost finance. The good news is that several initiatives have over the last four years been launched to cure this problem. Low-interest multi-lateral Development Bank lending with longer payback periods have come on board.
The African Development Bank (AfDB) in line with its vision for Africa’s pharmaceutical industry, has committed to invest US$3 billion for vaccine manufacturing over the next 10 years. In June 2024, US$1.2 billion for the African Vaccine Manufacturing Accelerator (AVMA) was launched. The innovative financing mechanism will be available over 10 years. In addition, the Afreximbank in 2024 unveiled a US$ 2 billion pledge in support of African Health Products Manufacturing.
A Pooled Procurement Mechanism (PPM) with the support of the Afreximbank and United Nations Economic Commission for Africa (UNECA) was also launched during the 37th AU Assembly to improve affordability, availability and equitable access to high-quality medical supplies across the continent.
Additionally, the European Investment Bank (EIB) and Afreximbank have each put €100 million in co-designed mechanism to enable scaled production of safe, affordable, and effective medicines across sub-Saharan Africa.
Also, according to Javier Niño Pérez, the European Union Ambassador to the African Union, by the end of 2024, MAV+ had mobilized investments in excess of €2 billion through 99 projects funded in a coordinated “Team Europe” approach by the European Union, EU member states Belgium, Germany and France, the European Investment Bank, and European Development Financing Institutions.
The MAV+ is an integrated and comprehensive support initiative aimed at tackling barriers in supply, demand, and enabling environment. Among its many funding aspects is the incentivising of investment in African health product companies with more than €800 million in loans and grants, including to companies focused on vaccine manufacturing (Afrigen, Aspen, Biovac, Institut Pasteur de Dakar, DEK) and other health products (Akagera, Emzor).
Pérez says the EU is also enhancing integration of African health product markets with €750 million to the African Vaccine Manufacturing Accelerator (AVMA), which is expected to purchase more than 800 million doses produced in Africa over the next decade.
Pérez also told The Independent that one effective modality of working with the AU across the work streams are the “embedded experts” who are working at Africa CDC and the AUDA-NEPAD, funded by Team Europe.
The experts have notably been supporting the fast-track operationalisation of the African Medicines Agency and the design of the African Pooled Procurement Mechanism. There are also specific actions at national level. For example, in partnership with the Rwandan government, Team Europe has established Master’s and PhD programmes in biotechnology at the University of Rwanda, enabling the training of medical professionals, biologists, and lab technicians from around the continent.
Meanwhile, the President’s Emergency Plan for AIDS Relief (PEPFAR), a U.S initiative, has been collaborating with the United States Development Finance Corporation to finance eligible private sector projects that build regional manufacturing capacity for therapeutics, and ancillary supplies in lower-income countries, with a focus on Africa. It is hoped these initiatives will go a long way in contributing to the longer-term goal of holistic pharmaceutical manufacturing in Africa.
Still, some of the experts who talked to The Independent remain guarded saying achieving the objective of expanding end-to-end African vaccine manufacturing capacity will require a carefully structured “Advance Market Commitment” that right-sizes volume targets and payments. This, they say, is what will incentivise manufacturer entry without creating barriers to future entrants or compromising market stability.
Skill and talent development
Experts have also told The Independent market shaping strategies and affordable financing should be complemented with building human skills and capacities and sharing of crucial knowledge around vaccine technologies and intellectual property.
There is no doubt that Africa, and particularly sub-Saharan Africa, suffers from acute skills shortages in pharmaceutical, biotechnology, and related industrial workforces. This scarcity has mainly been driven by brain drain of local talent, resulting in an overreliance on imported expertise.
According to recent modelling, the importation of skilled workers is a major potential cost driver for new vaccine manufacturing facilities in Africa. This is especially so because modern vaccines are more complex than small molecule pharmaceuticals, often requiring rare skills and highly specialised industrial processes.
This is why an ecosystem fostering skilled human resources is essential. “This applies not just to manufacturing but also to the full vaccine value chain, from research capacity and laboratory networks through to the manufacture of ancillary supplies, and which will require considerable and broad-based investment.”
According to Dr. Jean Kaseya, the Director General of Africa CDC, “Between 9000 and 14,000 full time employees will be needed in vaccine manufacturing and research roles across Africa by 2040.” In response, PAVM has proposed setting up a series of “Capability and Capacity Centres” to foster partnerships between research institutions, manufacturing companies and educational institutions.
Some experts are looking in the direction of the World Health Organization (WHO) Tech Transfer Hub or COVID-19 and other vaccines / routine biologics. A hub has been established in South Africa and six spokes already identified (Egypt, Kenya, Nigeria, Senegal, South Africa and Tunisia).
In addition to technology transfer, the hub is collaborating with local manufacturers, regulatory authorities, and other stakeholders to provide training and technical assistance to build and strenghten local manufacturing capabilities.
Manuel Batz, the Lead for the Global Programme, BACKUP Health, at the German International Development Agency, GIZ, told The Independent that regional collaboration is important, and the establishment of Regional Capability and Capacity Networks (RCCNs) is a key step forward.
By working as a network, he says, RCCNs can ensure that knowledge is shared and that the right skills are built at the right scale. Batz says skill and talent development is all about combining education, training, and collaboration – both locally and internationally.
Vaccine technology transfer
Currently, there is limited vaccine manufacturing technology transfer to Africa with majority being formulate/fill/package capacity. This, experts say, is due to the often complex nature of vaccine manufacturing. It also means that African vaccine manufacturers are only able to produce a fraction of what, they in theory, could produce.
Some experts have argued that human resource capacity has to be built hand-in-hand with technology transfer, including direct exposure to drug substance development and manufacture. This, experts say, will enable development of the wide range of specialisation needed across the vaccine value chain.
Fortunately, there appears to be goodwill to help the continent close this gap. “With the right legal frameworks and support, both parties can find a way to make this work for Africa’s vaccine manufacturing ambitions,” says Batz.
For example, Batz says, the Medicines Patent Pool (MPP), an organisation mandated to improve access to affordable and appropriate essential medicines in low- or middle-income countries, negotiates voluntary licensing agreements and enables technology transfers. A good example is the mRNA Technology Transfer Programme, which BACKUP Health supports.
“It’s about creating win-win partnerships – where Africa gets the support it needs to build manufacturing capacity and international companies see the long-term value in being part of the solution,” Batz told The Independent.
The recent Berlin Declaration from the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) also showed industry intent to accelerate manufacturing partnerships, business-to-business agreements, capability development support, voluntary licensing and/or early, voluntary technology transfer.
The Distributed Vaccine Manufacturing Collaborative convened by the World Economic Forum is also exploring options for industry and other partners to support an enabling environment for technology transfer. Still, much greater attention and investment will be required if technologies and know-how from experienced manufacturers are to support the expansion of local manufacturing.
Research & Development
Relatedly, experts say, participation in the full vaccine value chain requires investment over time in African biotechnology facilities and research capacity. This has been lacking on the continent over the last 80 years.
In 2021, PAVM set out an ambitious proposal for an R&D coordinating platform on the continent to support long-term investment in the sector. In addition, the CEPI (Coalition for Epidemic Preparedness Innovations) and the African Union Commission have recently agreed upon a memorandum of understanding also aimed at significantly enhancing vaccine R&D and manufacturing on the continent.
The willingness and ability of the private sector to invest in research, development and innovation is also a key aspect; together with a revised African manufacturing model that benefits from innovation from incumbent manufacturers.
Regulatory capacity
Across the world, medicinal product regulation is essential for health care systems to guarantee access to high-quality vaccines. However, in Africa, this has been lagging.
At the moment, a number of national regulatory authorities are working towards the much-coveted World Health Organization (WHO) ‘Maturity Level-3’ standard to allow authorisation of domestically manufactured vaccines.
Only Egypt, Ghana, Nigeria, South Africa, and Tanzania operate at this level which is the second highest level in the 4-tiered scheme. It means that only these authorities will be eligible for inclusion in the transitional WHO-Listed Authorities (WLA) that meet WHO and other international standards for ensuring access to safe, effective, and high-quality medical products.
Experts say expanding manufacturing capacity from this low baseline will necessitate strengthening of Africa’s regulatory environment.
Experts say the success of Africa’s vaccine manufacturing agenda is critically dependent on new facilities being able to export products to procurement partners like UNICEF with sufficient regulatory authorisation.
In response, there have been a number of recent positive developments. For example, progress has been made in establishing the African Medicines Agency (AMA), with the first meeting of the Conference of the States Parties (CoSP) to the AMA held in June, 2022 in Addis Ababa.
On the sidelines of the 2nd Vaccines and other Health Products Manufacturing Forum held in Cairo, in February 2025, the national regulatory authorities (NRAs) from seven African countries-Ghana, South Africa, Tanzania, Nigeria, Zimbabwe, Senegal, and Rwanda-signed a Memorandum of Understanding (MoU).
The agreement marked a significant milestone in strengthening regulatory systems across the continent by fostering collaboration and mutual reliance on regulatory decisions among signatory agencies while also creating an enabling environment for the local production of medical products.
“It is fulfilling to see the commitment that the Heads of African NRAs have towards collaborating with a common goal of ensuring timely access to safe, quality and effective medical products in Africa,” said Dr Mimi Darko, the Chief Executive Officer, Ghana Food and Drugs Authority.
“As we sign this MoU, we —the ML3 NRAs on the continent — commit ourselves to leading efforts toward a more harmonised regulatory landscape that strengthens local manufacturing and improves access,” he said.
Experts say while several nascent moves have been made towards developing African vaccine manufacturing capacity, many challenges remain. Urgent among them are priority investment in building national regulatory capacity to ensure adequate oversight of production sites, market authorisation and pharmacovigilance/postmarket surveillance and continent-wide regulatory harmonisation.
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This article is made possible by the African Union Media Fellowship programme, which is implemented by the African Union (AU) through the Information and Communication Directorate and supported by the European Union (EU). Its content is the sole responsibility of the journalist and does not necessarily reflect the views of the AU or the EU.
