According to the World Health Organization, only 3 percent of all doses of Covid-19 vaccines delivered in 2021 went to Africa, which is home to one-fifth of the world’s population. In the massive debacle of global vaccine inequality, it was Africa that lagged furthest behind as the pandemic raged, and had the least clout to negotiate contracts.
African leaders vowed to make sure this would never happen again. High-income countries and philanthropic groups pledged to help fund efforts to make access to vaccines more equitable. There has been a flurry of announcements of new partnerships and investments: plans to modernize the handful of existing pharmaceutical manufacturing operations in Africa; plans to build new ones; plans to send shipping containers from Europe with pop-up facilities to produce the new mRNA vaccines; plans for an mRNA production incubator that would spread open source technology across the continent.
Now some of the hype has dissipated and there are some signs of real progress. But it has also become clear how big the obstacles are.
There aren’t many shortcuts in the decades-long process of developing an advanced biotechnology industry that can make a standard vaccine for export, let alone develop an injection that protects against a new pathogen.
The African Union has set a goal of having 60 percent of all vaccines used on the continent produced in African countries by 2040 – down from 1 percent today – a plan that seems hugely ambitious given the current production landscape.
The big problem, as always, is money. The multi-step process of making vaccines requires high biosecurity and intensive quality control. The cost of putting everything in place means that vaccines made in Africa will cost significantly more than those made by the Indian pharmaceutical industry, which is the main supplier of routine vaccines used in Africa.
Manufacturers such as the Serum Institute of India, the world’s largest vaccine producer, have achieved huge economies of scale and taken over much of the market share held by European producers. But the Covid vaccine rollout made it clear that despite the low price of Indian-made vaccines, African leaders cannot afford to rely on them. In March 2021, as millions of serum-made doses of the AstraZeneca vaccine were on their way to Africa, the Indian government imposed an export ban and rerouted those vaccines to its own people.
The Africa Centers for Disease Control and Prevention say the continent’s existing vaccine market is worth an estimated $1.3 billion and is expected to grow to about $2.4 billion by 2030. But many who work in global healthcare say that buyers will have to pay a “resilience premium”. — a higher price for African-made vaccines, the production of which helps build the African industry. There is much less clarity about who is willing to pay that higher price.
The obvious candidate is Gavi, the organization that uses funds donated by high-income countries and major charities to buy routine and emergency vaccines for low- and middle-income countries. Gavi today buys half of the vaccines used in Africa.
Aurélia Nguyen, Gavi’s Chief Program Strategy Officer, says the organization is willing to sign pre-purchase contracts with new vaccine manufacturers in developing countries to assure business owners a revenue stream that will fund expansion investments.
“The traditional market economy that has brought us to a place where we have strong manufacturers in developing countries in Asia and Latin America will not take us to a place where we will have regional players on the African continent,” she said. . “Gavi is able to bridge the market failure.”
If Gavi can provide that cushion, these are the projects experts say are most likely to help the continent meet its goal of producing a majority of vaccines for Africans in Africa. Most will take at least three years before even running a bottling and packaging line.
Dakar’s Pasteur Institute was making a million doses of yellow fever vaccine a year before Covid, and business was falling. But it has recently been a prime target for new investment, nearly completing a major expansion of its existing production facility. It aims to increase production of the yellow fever vaccine to 50 million doses per year. A second site will produce a low-cost rubella and measles vaccine for the African market, with a production target of 300 million doses.
It will use a new biomanufacturing production platform from Univercells, a Belgian start-up that aims to make vaccine ingredients faster and in a smaller space.
“Progress in Dakar is the fastest I’ve ever seen in the world,” said Prashant Yadav, a medical supply chain expert at the Center for Global Development, who has visited the institute several times over the past year.
In South Africa
Aspen Pharmacare, one of the few serious pharmaceutical players in Africa before Covid, received a $30 million infusion of philanthropic funds to build a manufacturing process for four of the major childhood vaccines, including injections for pneumonia and rotavirus.
In 2021, the World Health Organization set up an “mRNA production hub” at a small biotechnology company in Cape Town called Afrigen Biologics and Vaccines with the aim of reverse engineering the Moderna Covid vaccine and then sharing knowledge about mRNA production in the South of the world. . Afrigen will move its Covid injection into clinical trials in early 2024. There is no longer a market for Covid vaccines, but the hope is that the process of designing, testing and manufacturing this product will build technological know-how to make others, including an mRNA injection for tuberculosis, an Afrigen priority.
Afrigen’s manufacturing partner is nearby BioVac Institute, which makes childhood vaccines for South Africa. BioVac has signed an agreement to bottle Pfizer’s Covid vaccine (a process called fill-finish) and has entered into a new licensing and technology transfer agreement to produce an oral cholera vaccine with the International Vaccine Institute, a Southern Korean non-profit organization.
In mid-March, six shipping containers arrived in the country to form the first “BioNTainer” — a pop-up production line for mRNA vaccines packaged in the containers — donated by BioNTech, the maker of the mRNA technology in Pfizer’s Covid vaccine. The modular site is intended to form the core of a new vaccine production center. According to BioNTech, it will be staffed by Europeans for the first five years.
A major challenge here, noted Dr. Yadav on, is that the site has no vaccine to make: there is no demand for the Covid vaccine and BioNTech is not currently making any other product. An mRNA vaccine against malaria or tuberculosis that could prove useful to Rwanda and the region is most likely a decade away. The new capacity in the country is for production only; in Rwanda, as in most other African countries, there is no biotech industry capable of the kind of research and development essential in responding to a new pathogen, said Alain Alsalhani, a vaccine expert with access to medicines from Doctors without borders campaign.
Two other companies – Biogeneric Pharma in Egypt, which will receive an mRNA technology transfer from Afrigen, and SENSYO Pharmatech in Morocco – have received significant investment to expand their production. And in Kenya, the government is allowing the Kenya BioVax Institute to switch from producing vaccines for animals to making vaccines for humans. It has dr. Michael Lusiola, a Kenyan expatriate who was a senior executive at AstraZeneca in the UK, to come home and run it.
Ms Nguyen said having the ability to produce large numbers of vaccines would help provide Africa with security in the event of another pandemic. The continent could build that capacity by making routine vaccines for the African market, she said.
In most cases, that will mean starting with fill-finish agreements on existing vaccines – putting a bulk vaccine made elsewhere in vials. Then companies can start producing the actual drug substance and eventually do the research and develop the vaccines, either for known pathogens or new ones.
Countries will need stronger regulatory bodies so their vaccines can be quickly approved for export. They will also need better supply chains of everything that goes into vaccines. The Africa CDC hopes to create regional ones, in which some countries make glass vials and make other medicines, as a way to ensure fair access in a future pandemic.
Ms. Nguyen said she was encouraged by the number of African initiatives embracing new technologies that allowed them to “leapfrog”. In the past, making vaccines required a huge physical footprint, so that meant huge volumes had to be produced to pay for them.
“Having a small unit that can get going and do five or 10 million doses and then switch to something else — I think that really changes the established market,” she said.
Many of the new initiatives rely heavily on philanthropic funding, largely from the Bill & Melinda Gates Foundation and the multilateral Coalition for Epidemic Preparedness Innovations, as well as low-cost bilateral loans. It is not clear how long that enthusiasm will last. Martin Friede, who heads the vaccine research unit at WHO, predicted that “the Covid guilt will be over by this afternoon”. He added: “I just don’t see South Africa agreeing to buy vaccines from Nigeria at a higher price than vaccines from India or Europe – that’s a tough question.”
Patrick Tippoo, the chief scientist at Biovac in Cape Town and a key player in the African network of manufacturers, said this was similar to what he and his colleagues heard in meetings. “There is a lot of goodwill from development finance institutions,” he said, but concerns about how manufacturers can repay loans. “That depends on product volumes and access to markets,” he continued. “So we’re kind of going around in circles.”
BioVac’s new cholera vaccine is a good example of the promise of this new manufacturing capability and the obstacles it faces. There is a critical worldwide shortage of that vaccine and outbreaks are raging in several sub-Saharan countries. This will be the first time in decades that an African drugmaker will develop a strategic vaccine, taking it through the full chain of clinical development to production, regulatory approval and, BioVac hopes, prequalification by the WHO for worldwide use. But it will be a process of many years – and the construction of costly new facilities will be necessary.
“A number of things have moved forward and if half succeeds, we are doing well,” said Mr Tippoo. “It’ll get us closer — the question is, will it get us close enough?”