Pandemics such as COVID-19, Ebola, and the 2009 influenza instilled the need for a well-equipped domestic vaccine manufacturing industry in the minds of African leaders. Currently, due to insufficient local production, the continent depends heavily on imports from other countries, with the imports satisfying about 99% of vaccine demand in the continent. Thanks to recent significant FDI, Africa’s vaccine industry had a market potential of around US$1.3 billion in 2021. McKinsey estimates it could reach US$2.3 billion to US$5.4 billion by 2030.
Vaccine sovereignty needs local supply, not just local ambition
One of the most important lessons the COVID-19 pandemic has given to Africa is the pressing need to ramp up vaccine production locally. Biotech firms, such as Moderna and Pfizer, developed COVID-19 vaccines faster than any other producers. However, these vaccines were not easily accessible to most African countries.
Africans, in general, lack access to affordable and quality healthcare. Preventable diseases, such as pneumonia, malaria, and typhoid fever, have high fatality rates across the continent. This calls for localized production of pharmaceuticals and vaccines to lower the economic burden of these diseases and facilitate better access to affordable healthcare.
Currently, Africa relies heavily on other countries, such as China and India, for its pharmaceutical needs. The paucity of localized pharma production aggravates healthcare and vaccine inequity across the continent. To substantiate this, the COVID-19 vaccination rate at the beginning of 2022 in 16 African countries was less than 5% on average.
Currently, Africa consumes around 25% of the global vaccine production, whereas it produces less than 1% of its vaccine needs locally, as per the African Union (AU). Therefore, a lot remains to be done to reach the goal of meeting 60% of vaccine needs locally by 2040. This is the vision of the Partnerships for African Vaccine Manufacturing (PAVM) under Africa CDC.
Increasing the vaccine production capacity from 1% to 60% in 15-16 years is not an easy task. Considering this, PAVM designed a continental plan for creating a vaccine production ecosystem capable of achieving the 60% target. This plan, called the PAVM Framework for Action (PAVM FFA), set out the scale of the buildout. It assessed that Africa’s vaccine factories would need to increase from 13 in 2023 to 23 by 2040. This would include 11 form, fill, finish, or F&F factories and 12 end-to-end factories, providing 22 priority products by 2040. It will require dedicated efforts from all involved stakeholders, such as producers, biopharma companies, industry associations, regulatory bodies, and academia.
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FDI brings vaccine factories, but demand must follow
The continent is attracting considerable FDI from the USA and Europe for vaccine development. Several foreign biotechnology firms are partnering with African governments to venture into localized vaccine production.
In March 2023, US-based biotechnology company Moderna partnered with the Kenyan government to set up a production facility for making messenger RNA (mRNA). The proposed annual capacity of Moderna’s first-ever facility in Africa is around 500 million doses of vaccines. The facility is expected to produce drug substances or active pharmaceutical ingredients and the final product for the entire continent.
In another example, a Germany-based biotechnology company, BioNTech, is contemplating commencing production of mRNA-based vaccines in its Rwanda facility in 2025. The construction of the facility began in 2022. With an investment of around US$150 million, this is Africa’s first mRNA manufacturing facility built by a foreign company. The proposed annual capacity of BioNTech’s mRNA facility is about 50 million vaccine doses. BioNTech also plans to set up mRNA factories in other African countries, such as South Africa and Senegal. It plans to produce vaccines for malaria, tuberculosis, HSV-2, and HIV in the future.
In September 2023, the South African government partnered with the KfW Development Bank of Germany. As per the agreement, South Africa will receive €20 million from Germany’s KfW Development Bank over five years for developing and manufacturing mRNA vaccines. The fund will cover equipment procurement and API certification for vaccine production in South Africa.
The Global Alliance for Vaccines and Immunizations (GAVI), AU, and Africa CDC formed a consortium. It established the African Vaccine Manufacturing Accelerator (AVMA) to foster a sustainable vaccine industry. The formation of AVMA involved donors, partners, industry stakeholders, and non-governmental and not-for-profit organizations. GAVI planned to expand its supplier base, mainly in Africa, in 2021. Furthermore, the global alliance announced the commencement of around 30 vaccine manufacturing projects across 14 African countries.
Moreover, as of December 2023, over US$1.8 billion is planned for investment by a collaboration between the French government, Africa CDC, and other European and international investors to streamline the development and production of vaccines across the continent.
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mRNA preference leaves local non-mRNA vaccine plants exposed
African governments are not only proactively putting in dedicated efforts to attract considerable FDI to build and strengthen the continent’s vaccine manufacturing industry. They also focus on the quality and effectiveness of vaccine types. However, some perceive this as a lack of interest from the African governments in buying non-mRNA vaccines made by local companies.
For example, Aspen Pharmacare, a South Africa-based biotechnology company, made significant investments in ramping up the capacity of its manufacturing facility. The goal was to produce viral vector vaccines against COVID-19. The company announced in November 2020 that it would be formulating, filling, and packaging the COVID-19 vector vaccine made by J&J. It also received a €1.56 million investment from Belgian investors, BIO, the Belgian Investment Company for Developing Countries. BIO is a JV between the European Investment Bank (EIB) and several European DFIs.
However, millions of J&J COVID-19 vaccine doses made in South Africa were exported to Europe by J&J without the knowledge of the South African government. This was to support Europe’s domestic vaccine demand in August 2021, not complying with the initial agreement of vaccine distribution within the African continent. This created a political impasse between European and African governments over vaccine distribution. The standoff delayed production by leaving Aspen Pharmacare waiting longer to produce the COVID-19 vaccine.
Ultimately, by September 2021, the European countries agreed to return 90% of the J&J vaccines to Africa. In March 2022, J&J gave Aspen Pharmacare the license to manufacture and distribute the vaccine under its brand name, Aspenovax. The expected production capacity of Aspenovax was around 400 million doses. However, not a single order came from African governments. According to Health Policy Watch News, the reason was the rising supply of Pfizer and Moderna’s mRNA COVID-19 vaccines. COVAX distributed those vaccines, and most African governments were opting for them.
Thus, in August 2022, Aspen Pharmacare had to close its production line, citing nonexistent demand in Africa. Demand had fallen partly because the pandemic had subsided and partly because African governments lacked interest in non-mRNA vaccines. The company could not sell a single dose of the vaccine, owing to multiple factors. These included what was perceived as the government’s lack of intent to purchase home-grown vaccines. They also included delayed production due to the Europe-Africa political clash and the world’s rising inclination toward mRNA vaccines.
It is interesting to note that of the total Covid-19 vaccines Africa administered to its residents, 36% were J&J vector vaccines, shipped directly from the USA.
Technology transfer starts closing Africa’s vaccine skills gap
To strengthen vaccine production capacity in low- and middle-income countries (LMICs), the WHO declared the establishment of a technology transfer hub in Cape Town, South Africa, in June 2021. In February 2022, the WHO named the first African countries expected to receive support from the hub. They included Nigeria, Kenya, Senegal, Tunisia, and South Africa. The support would include technical expertise and training needed to make mRNA vaccines in Africa.
Afrigen Biologics, a South Africa-based biotech firm, is leading this initiative. As Moderna did not enforce patents on its mRNA COVID-19 vaccine, Afrigen Biologics could successfully reproduce the vaccine, capitalizing on the data available in the public domain. As per an October 2023 article, Afrigen Biologics reached a stage where its vaccine production capabilities are appropriate for “phase 1/2 clinical trial material production”. Additionally, in collaboration with a Denmark-based biotech firm, Evaxion, Afrigen is developing a new mRNA gonorrhea vaccine.
Besides setting up a technology transfer hub in South Africa, academic institutions are partnering with non-profits and companies. These partnerships aim to build the technical know-how and training needed for vaccine manufacturing. One such example is the development of vaccines in Africa under the partnership of Dakar, Senegal-based Pasteur Institute (IPD), and Mastercard Foundation. Approved in June 2023, MADIBA stands for Manufacturing in Africa for Disease Immunization and Building Autonomy. Its goal includes improving biomanufacturing on the continent by training dedicated staff for MADIBA and other African vaccine producers. It also includes partnering with African universities and fostering science education among African students.
Overcapacity and weak antigen output threaten vaccine profitability
With 13 vaccine manufacturing companies and academic organizations across eight African countries, the continent’s vaccine industry is in its infancy. However, the current vaccine manufacturing landscape includes a mix of facilities. These include 10 F&F facilities, three R&D facilities, and five drug substance or active pharmaceutical ingredient development facilities.
One of the challenges African vaccine producers face is not being able to become profitable in the long run. In 2023, a global consulting firm, BCG, in collaboration with BioVac, a South Africa-based biopharmaceutical company, and Wellcome, a UK-based charitable trust that focuses on research in the healthcare sector, conducted a detailed survey exploring stakeholder perspectives on challenges and feasible solutions. The respondent pool consisted of a diverse set of stakeholders spanning across Africa (43%), LMICs (11%), and global (46%).
According to this research, most vaccine producers in Africa say that profitability is one of their key concerns. This leads to a lack of foreign investments required for scaling up, which in turn creates insufficient production capacity, thereby increasing the prices of vaccines. Therefore, these producers are unable to meet considerable demand for their products, and their business model becomes unsustainable.
Continued commitment and support from all stakeholders are necessary for achieving a sustainable business model for vaccine producers in Africa and, consequently, for the industry at large. However, the support from global, continental, and national levels of governments and other non-government stakeholders, such as investors, donors, partners, etc., tends to diminish with the declining rampage caused by epidemics in Africa. Therefore, this poses a severe challenge to strengthening the vaccine production industry in Africa.
Another 2023 study, by a collaboration between the African CDC, the Clinton Health Access Initiative (CHAI), a global non-profit health organization, and PATH, involving 19 vaccine manufacturers in Africa, suggested that the current vaccine production capacity, including current orders to form/fill/ finish using imported antigens, is nearly 2 billion doses. In contrast, the current average vaccine demand is 1.3 billion doses annually. The proposed F&F capacity is over 2 billion doses. Thus, if Africa can materialize both current and proposed plans of producing F&F capacity vaccines from imported antigens, the continent can reach a capacity of more than double the forecasted vaccine demand in 2030. Overcapacity will lead to losses due to wastage. Thus, not all vaccine producers will be profitable in the long term. This may challenge the African vaccine manufacturing industry to be profitable.
Moreover, Africa’s current domestic antigen production capacity is lower than what is required to meet PAVM’s vaccine production target of 60% by 2040. In addition, a large part of the existing antigen capacity is being utilized to make non-vaccine products. Although antigen production plans are underway, these will not suffice to narrow the gap between demand and production of antigens domestically in Africa.
EOS Implic-Action: Vaccine makers need steady demand beyond outbreaks
To create a local, financially sustainable vaccine manufacturing industry with output adequate to support the continent’s needs, it is necessary to create an environment in which producers can achieve profitability.
Initiatives such as technology transfers and funding will only be fruitful when their on-the-ground implementation is successful. This will require the involvement of all stakeholders, from the state governments to bodies that approve the market entry of vaccines. All stakeholders need to be steadfast in their actions to achieve the ambitious target of 60% of vaccine needs to be met from local production by 2040 without compromising on the accuracy and quality of the vaccines.
One of the most vital aspects of the necessary planning is for stakeholders to ensure that even after the pandemic and its aftermath are entirely gone, the effort towards establishing facilities, creating know-how, and training a workforce skilled in vaccine development and production does not stop.
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The focus should extend beyond COVID-19, as there are many other preventable diseases in Africa, such as malaria, pneumonia, tuberculosis, and STDs, against which vaccines are not yet produced locally. These areas provide a great opportunity for vaccine producers and associated stakeholders to continue being interested and involved in vaccine production and development in Africa.