The Independent Uganda: You get the Truth we Pay the Price
Can the continent walk the talk?
****
The African Union has embarked on one of its most audacious health security missions: Ensuring that the continent manufactures 60% of its own vaccines by 2040. Africa 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 first of a four-part series, The Independent’s Ronald Musoke, unpacks the continent’s plan, looking at both opportunities and hurdles.
****
From its headquarters in the Ethiopian capital, Addis Ababa, the Africa CDC is working on the mission together with international partners such as the European Union, GAVI, and international financial institutions, such as the African Development Bank and the World Bank.
A major achievement, so far, has been setting up the Partnership for Africa Vaccine Manufacturing (PAVM) to develop the “framework for action” of the mission. That was in 2022. Another milestone was in February 2024, when PAVM was renamed the “Platform for Harmonised African Health Products Manufacturing (PHAHM) to reflect its expanded mandate that now includes developing “medical countermeasures.”
The target year, 2040, might be 15 years away but the Africa CDC Director-General, Dr. Jean Kaseya, is leading the mission with a sense of urgency. He says the continental leadership learnt a big lesson during the COVID-19 pandemic.
“We saw during COVID-19 that all other countries can lock their doors and we (Africa) are left on our own; we saw with COVID-19 that African people could never survive if they did not get what others were calling appropriate vaccines. Who can accept that?” he says.
As head of an autonomous continental public health agency mandated by the AU to strengthen the capacity of African countries to respond quickly and effectively to disease threats, Dr Kaseya says he does not want a repeat of that.
In late November 2023, on the opening day of the International Conference on Public Health in the Zambian capital, Lusaka, the Congolese-born expert in epidemiology and community health told journalists that local manufacturing of vaccines will mark the “second independence of Africa.”
“I repeat, local manufacturing is the second independence of Africa,” he said, adding that it’s a message he preaches every day. He says the Covid-19 pandemic exposed the continent’s vulnerability and overly dependence on other continents for vaccines, medicines, diagnostics and other health commodities. “Our countries got independence in 1960. But we saw with COVID-19 that Africa is not independent.”
Dr. Abebe Genetu Bayih, the Acting Lead of PHAHM also recalls the tough COVID days; especially when money became available but Africans could still not be allowed to buy vaccines.
“We were unable to buy lifesaving vaccines even when the money was available,” he told The Independent recently in an email, “As a lesson learned, African leaders decided to put the agenda of vaccine manufacturing as a top and central continental priority to avoid the COVID-19 scenario in the future.”
AU Vaccine agenda
Dr. Bayih says the AU wants governments, manufacturers, national regulatory authorities, donors, and funders, to work in a coordinated, concerted multi-year effort in order to overcome constraints along the path to vaccine independence.
He says the venture is witnessing a sub-optimal availability of finance from the traditional financing institutions because “vaccine manufacturing is a high-risk endeavour.” He also mentions the need for a robust regulatory framework to ensure that African manufacturers adhere to quality, safety, and effectiveness of vaccines.
Already, the Africa CDC and partners have concluded a study on the current vaccine manufacturing, supply and demand landscape in Africa with findings suggesting that the continent has 25 active vaccine manufacturing projects at three different stages of development.
Dr. Bayih told The Independent that five of these have commercial-scale manufacturing facilities with technology transfers signed or underway; five have commercial-scale manufacturing facilities but have yet to sign technology transfers and 15 manufacturers are still in the early stages of development.
According to the African Manufacturing Landscape survey, currently, there are 574 health products manufacturers active in Africa. Among the existing vaccine players, about 40% engage in just packaging and labelling, and 40% engage in “fill-and-finish,” while five local companies engage in some degree of drug substance manufacturing, but mostly at a very small scale, with limited ongoing research and development (R&D) activity in the facilities.
This, experts say, is mainly due to a lack of local scientific capacity, along with weaknesses in the commodity supply chain, prohibitive regulatory regimes, powerful trade blocs, scarcity of potential buyers of vaccines, competition with subsidized markets, political instability, geographical and logistical challenges, lack of sustainable financing mechanisms and low economic purchasing power on the continent.
According to the Africa CDC, in the next five years, three African vaccine manufacturers are expected to produce and secure “World Health Organisation (WHO) prequalification” for nine different vaccines and supply the continental market. A few additional manufacturers will also produce vaccines at scale to supply their respective countries.
Case for local vaccine production
The demand for Africa-manufactured vaccines and medicines is big. The continent has around 16% of the world’s population and suffers 25% of the global disease burden and over 50% of the world’s infectious disease burden including; HIV, Ebola, malaria, Lassa Fever, cholera, dipththeria, tetanus and pertussis (Whooping cough).
Yet, despite having the highest global incidence of mortality caused by infectious diseases, just under 1% of the vaccines required by Africans are produced in Africa. At the moment, Africa imports 99% of its vaccines, with seven of every 10 vaccines used in Africa currently being donated through GAVI, the Vaccine Alliance. This, experts say, has created a significant health security risk on the continent. Africa’s ever-growing population is expected to shoot from the current 1.4 billion people to 2 billion by 2040. This will ensure a three-fold increase in vaccine demand.
Other experts who have talked to The Independent say demand for vaccines is set to more than double in volume from 1 billion doses today to over 2.7 billion doses in the next 15 years. By producing vaccines locally, Africa will ensure that its people have timely and equitable access to critical vaccines, reducing reliance on external suppliers and mitigating supply chain vulnerabilities, Natasha Kofoworola Quist, a communications specialist at VaxSen, the commercial subsidiary of Senegal’s Institut Pasteur de Dakar, told The Independent.
Itai Rusike, the Executive Director of the Harare-based Community Working Group on Health (CWGH) -Zimbabwe, says Africa must take a leaf from the way the developed world tackled COVID-19. “A vaccine was developed, prequalified and administered within a single year. Yet we still grapple with diseases that are centuries old simply because they mostly only affect Africans, our pace remains too slow and yet we can do it,” he told The Independent.
Dr. Bayih also told The Independent that investing in a local vaccine manufacturing industry in Africa will result in significant long-term benefits, including increased sovereign health security, harmonisation of regional regulatory and trade policy, a boost in technological expertise, higher GDP, higher employment, and savings from substituted imports.
Priority diseases
The African Union has already prioritized vaccine manufacturing for up to 22 diseases including the “legacy diseases” (Dipththeria, Whooping Cough, Tetanus, Hepatitis B, Yellow Fever, Tuberculosis, Measles, Typhoid Fever, Cholera, Meningitis). In the near future, the AU intends to expand production of HPV (Human Papillomavirus), HIV, Pneumococcal, COVID-19 and Rotavirus vaccines. It is also keeping an eye on vaccines for Ebola, Chikungunya, Rift Valley Fever, Influenza, Lassa Fever, among others.
International support
In a bid to support Africa’s domestic vaccine manufacturing, several international partners including development financing institutions like the World Bank, the Africa Development Bank (AfDB), the European Investment Bank and the AfreximBank have pledged billions of dollars worth of investment in the vaccine manufacturing and supply value chain for Africa while GAVI, one of the main buyers of vaccines that are administered on the continent has, in principle, also pledged to support the continent’s vaccine programme.
With such assurances, over the last three years, billions of dollars worth of investments aimed at creating 23 vaccine manufacturing plants on the continent have been mooted. On 20 June, 2024, the European Union launched a U.S$ 1.1bn project to accelerate vaccine production in Africa.
The EU said the programme would offset start-up costs and ensure demand for vaccines in Africa. “Importantly, it will also support the sustainable growth of Africa’s manufacturing base and contribute to the African Union’s ambition to produce most vaccines required by African countries on the continent,” the EU said in a statement.
Nurturing partnerships and marshaling resources
All this is being done in close collaboration with African partners at national, regional and continental level (Africa CDC and AUDA-NEPAD), says Javier Niño Pérez, the European Union Ambassador to the African Union.
For example, by the end of 2024, the Manufacturing and Access to Vaccines, Medicines and Health Technologies in Africa (MAV+ ) initiative had mobilised 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+ initiative is an integrated and comprehensive support aimed at tackling barriers in the three dimensions of supply, demand, and enabling environment. One aspect is looking at strengthening public health agencies and regulatory frameworks with support for Africa CDC and the African Medicines Agency (through AUDA-NEPAD, WHO and the European Medicines Agency) to drive impact at continental level.
The second aspect is looking at boosting the continental ecosystem for product development and equitable access with €107 million set aside for the creation of an African centre of innovation for mRNA vaccines and therapeutics, the WHO – Medicines Patent Pool Technology Transfer Hub located in South Africa.
The third aspect is looking at incentivising 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 of Dakar, DEK Vaccines) and other health products (Akagera, Emzor).
Pérez told The Independent that enhancing integration of African health product markets with €750 million to the African Vaccine Manufacturing Accelerator (AVMA) is expected to purchase more than 800 million doses produced in Africa over the next decade.
Still, continental experts like Jane Nalunga, the Executive Director of the Southern and Eastern Africa Trade Information and Negotiations Institute (SEATINI-Uganda), a Kampala-based thinktank, see a number of issues which Africa must confront head-on to achieve vaccine independence. One, is the issue of Intellectual Property, particularly patents, she says. “Patents are controlled by private companies and they are not into charity; patents are about money and making more money.”
Dr. Bayih agrees.
“African vaccine manufacturing requires an optimum technology transfer scheme that benefits both the innovator and the tech recipients. Moreover, African manufacturers should invest in making themselves tech transfer ready,” Dr. Bayih told The Independent.
But, Dr. Adrian Ddungu Kivumbi, the Secretary General of the Uganda Pharmaceutical Manufacturers Association (UPMA) told The Independent that “the 15-year timeline to the 2040 target is too long.”
“From what I’ve learned about vaccine manufacturing, the agenda that the African Union has established can be achieved,” he says. The only limitations Dr. Ddungu foresees are majorly limitations in funding, regulatory framework, and lack of political will.
“I will not even say that we lack manpower because we have highly skilled scientists that end up going elsewhere because we don’t pay them as much. If the salaries or the environment of work is conducive, we can have many people (retained) here (Africa). So we need to clean our own house.”
And perhaps, more importantly, sustainable manufacturing of vaccine at scale must offer a predictable demand and offtake guarantee. Member states of the AU will have to commit to buy African made vaccines. In order to avoid duplication and a potential waste of resources and fragmentation of the market, there also needs to be a continental coordination mechanism.
Dr. Bayih says the success of African-made vaccines will be based on the ability to leverage the AfCFTA free movement of goods and harmonization of trade policies across Africa.
“Eliminating trade barriers, boosting intra-Africa trade, advancing trade in value-added production are AfCFTA goals that Africa CDC will rely on to deliver the ambition of manufacturing 60% of vaccines need by 2040.” Dr. Bayih told The Independent that the AfCFTA Secretariat and Africa CDC are working together to remove any bottlenecks, therefore supporting African vaccine manufacturers.
For Manuel Batz, the Lead for the Global Programme BACKUP Health at GIZ, the German International Development Cooperation Agency, there are possibilities for Africa to build strong partnerships with international pharmaceutical firms to overcome this.
“First, it's about finding ways to create mutually beneficial relationships. For example, international companies could be drawn to the growing African market and the potential for long-term partnerships,” he says, adding that: “Access to new markets could be an attractive proposition.”
The other possibility Batz is looking at is focusing on technology transfer agreements that respect IP rights but also create a framework for local capacity-building. For instance, he says, companies could provide access to know-how, training and raw materials while keeping their IP protected. “This allows African manufacturers to build their skills and capacities over time, leading to greater self-reliance and autonomy in vaccine manufacturing,” he told The Independent.
Batz says international organisations or multilateral frameworks could step in to mediate and facilitate agreements that ensure fair access to technology while protecting IP rights. “With the right legal frameworks and support, both parties can find a way to make this work for Africa’s vaccine manufacturing ambitions,” he said.
For example, the Medicines Patent Pool (MPP), an organisation mandated to improve access to affordable and appropriate essential medicines in low- or middle-income countries, for instance, plays a role by negotiating voluntary licensing agreements and enabling technology transfers. A good example of how this aligns with Africa’s goals 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.
Dr. Denis Kibira (PhD), the Coordinator of the Medicines Transparency Alliance (MeTA), a multi-stakeholder initiative that brings together governments, civil society and the private sector on the continent to improve access to pharmaceutical markets believes the continent can achieve its lofty aspiration.
“Manufacturing of pharmaceuticals including vaccines on the African continent is no longer an option but a must,” he told The Independent.
Dr. Sabrina Kitaka, a Paediatrics Infectious Disease Specialist and an immediate former member of the Uganda National Immunization and Technical Advisory Group (UNiTAG) told The Independent that, Africa has multiple recurring epidemics such as Ebola, Marburg and now MPox that need urgent attention and vaccines.
Prof. Pontiano Kalebu, the Director of the Uganda Virus Research Institute (UVRI) agrees.
“I always tell people that we can't wait. Even if we don't reach the goal in our lifetime, we have to work for the future, for future generations, so we cannot stop. We cannot say, this is not possible, we'll leave it for others.”
“We have diseases here that are common, killing children, and also Africa is prone to emerging and re-emerging infections, so I see it as very important that Africa gets involved in development of vaccines.”
*** ***
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.
