In two years, a Covid-19 vaccine developed in Africa for Africans will be approved, with human trials expected to start early next year.
The vaccine candidate produced from mRNA technology will be the first to be designed, developed and assembled at a laboratory scale in Africa, thanks to the hub at Afrigen Biologics and Vaccines, a biotechnology company that may help the continent end its overreliance on developed countries.
The lack of soup-to-nuts manufacturers is one major reason low- and middle-income countries, and specifically Africa, were boxed out of buying Covid-19 vaccines when the pandemic first hit.
Globally, the concentration of vaccine production in a few high-income countries has led to vast inequities in access to Covid-19 vaccines, with more than 80 per cent of Africa’s population yet to receive a single dose.
Africa produces only one per cent of the vaccines it needs but the continent uses 25 per cent of all vaccines produced globally.
The failure to globalise the vaccine ecosystem to include production in a greater number of lower-income countries amplified global inequities in vaccine access.
Without a manufacturing hub that produces at least 50 per cent of the vaccines Africa needs, there will never be research and development capability. There will also be no pandemic preparedness, no vaccine and health equity.
“We have to build this sector at all costs. This is our breakthrough as a continent and it’s now,” said Prof Petro Terblanche, Afrigen's managing director, when journalists toured the facility in Cape Town, South Africa, earlier this month.
Several disease outbreaks have been reported on the continent in recent years, mostly recently Ebola in Uganda and the Covid-19 virus, yellow fever, swine flu, polio, measles and monkeypox.
“If African countries come together and make Afrigen the mRNA vaccine hub, then the continent will have their first vaccine manufacturing hub, making it the first mRNA vaccine ever in Africa to receive approval by the World Health Organisation,” Prof Terblanche said.
The majority of mRNA vaccine trials have been going on in high-income countries, with minimal interest in Africa. Only two mRNA vaccines have been approved for Covid-19 – one from Moderna, and the other from Pfizer and BioNTech.
The mRNA vaccine teaches its cells how to make a protein that will trigger an immune response in one’s body, rather than putting a weakened or inactivated germ into the body.
With the lessons learnt after Covid-19 and the need for Africa to produce its own vaccine, the WHO in April last year asked countries to send proposals to scale up production and access to coronavirus vaccines.
Afrigen then partnered with Biovac and the Medical Research Council (MRC) and made a proposal as a consortium. The hub was to develop the technology and transfer the first spoke to Biovac and MRC to develop a pipeline of next-generation vaccines.
“We saw this as an opportunity to establish and develop vaccines for neglected diseases in low-income countries that are of no priority to high-income countries because either the market is smaller or return investment is not there,” Prof Terblanche said.
About 28 countries declared their interest, and on June 21, the WHO announced that the South African consortium had been selected to establish the first Covid-19 mRNA vaccine technology transfer hub in Africa.
“I could not believe it when the announcement was made. It completely changed the face of this company and the continent,” said Prof Terblanche.
She added: "This placed the power in our hands to produce a vaccine in Africa for our African population and for future pandemics.”
At the hub, manufacturers from low- and middle-income countries are trained on the entire process of developing a vaccine through the technology.
Until recently, Afrigen specialised in developing veterinary vaccines using fairly traditional methods. The company’s laboratories are now a hive of research into the cutting-edge technology behind mRNA vaccines.
“This is the ideal target product profile for low- and middle-income countries,” Prof Terblanche told Nation.Africa in Cape town.
“The hub targets to lower cost of goods as well as reducing the cost of producing the same vaccine for the same safety and efficacy.”
The WHO asked Moderna to transfer technology to Afrigen. Afrigen will then conduct the clinical trial development and transfer the technology spoke to countries including Kenya.
Biovac, a partly state-owned South African vaccine producer, will be the first recipient of the technology from the hub.
Scientists in Cape Town made their own version of the vaccine using the same sequence as the Moderna vaccine, 1273.
“I think that the scientists and scientific capability in South Africa were underestimated by the world,” said Prof Terblanche.
“Technology is not a given privilege for the rich or for some countries and not for others. We need to really bring technology home to all of our countries.
“We were confused for weeks; we did not know what to do. Our scientists then regrouped, took the sequence that was in the public domain and moved to the innovation process. We used our knowledge, skills and experience and made our own vaccine.”
She added: “We went through several challenges. We were developing a new product with no regulatory process, no validation, no transfer of clinical data. We had to do everything from nothing.”
In three months, with the University of the Witwatersrand, Johannesburg, the hub produced its first micro-litre laboratory-scale batches of Covid-19 mRNA vaccines at the Cape Town facility. Although the quantities made so far are small, it's been developed more quickly than many expected.
The team started in November last year and after validation, qualification and formulation, a vaccine candidate was developed.
“We started all the way from groundwork, all the qualifications, developing the process and ensuring that licensing and quality were in place, an amazing process, all these achieved in months is unbelievable. We still have more to do,” Prof Terblanche said.
“We proudly announced the results. We surprised the world and even the Moderna team that underestimated our researchers. It was phenomenal and unbelievable how the African team could do this. Many people still don’t believe we have an African vaccine.”
Prof Patrick Arbuthnot of the University of Witwatersrand, who helped produce the lab-scale samples for Afrigen, said that even with Moderna’s refusal to share its patent, they were determined to push ahead.
“I was not shaken and I am glad we hacked it,” he said.
“The vaccine candidate was tested on mice, the product elicited a strong anti-spike immune response. Mouse proof of concept study conducted at the university confirmed immune response and neutralising antibody after boost comparable to the control, reference vaccine,” the study says.
There was no reactogenicity observed at the injection site. The clinical safety study on rats has begun, with the trials on humans set to begin early next year and the approval of the vaccine expected in 2024.
It could take a couple of years for large-scale production of the vaccine to begin.
The company is working on cloning the vaccine as part of the WHO's effort to make technology and treatments related to Covid-19 more widely available around the world.
The hub is ready for the clinical trials and what is left is the arrival of equipment, which will have to go through regulatory qualifications on whether they can produce a safe and effective vaccine.
The hub will not only produce Covid-19 vaccines but the knowledge and the technological know-how will be used to produce other vaccines suitable for mRNA, including for HIV, malaria and tuberculosis.
Prof Terblanche explained that the model the hub is using is different from the bigger pharmaceutical model. Batch sizes are smaller, giving the hub unique flexibility.
The model, she explained, does not have to be big to be sustainable and relevant.
“At the hub, we can make a quick vaccine even for disease for a small group of people. You cannot get this in a facility that is geared towards making profits and bigger batch sizes of vaccines. We are not a profit-oriented facility,” she said.
The end goal is to contribute to public health and have enough money to invest in vaccine accessibility.
The advantage of the mRNA technology is that little can go a long way. The hub has the capacity to produce 50 million doses of vaccines.
“The biggest part of this facility is not the production of mRNA but quality. That’s why the facility is small but can produce millions of doses,” she explained.
The five-year project is funded by taxpayers from high-income countries including France, Germany, Canada, Belgium, Switzerland, Norway, and the South African government to the tune of $107 million.
On sustainability, she said, there was a need for an ecosystem and African governments to commit to local manufacturing and to see the benefit of the hub.
“The time is now. We must make this work. We have to invest and guard it as our project or else it will turn into a white elephant project that never picked up,” Prof Terblanche said.
She added: “It is essential that African leaders have the ability to have a long-term plan. We will have to pay a premium, to think long term and be able to absorb, where possible, premiums of local manufacturing because ultimately, it changes your world.”
The Covid-19 pandemic demonstrated that reliance on a small number of companies “to supply global public goods is limiting, and dangerous”, WHO Director-General Dr Tedros Adhanom Ghebreyesus has said.
“In the mid to long term, the best way to address health emergencies is to significantly increase the capacity of all regions to manufacture the health products they need, with equitable access as their primary endpoint.
“We expect the benefits of this initiative will extend far beyond Covid-19 by creating a platform for vaccines against other diseases, including malaria, tuberculosis, and even cancer.
“This is a strategic investment, not just for Covid but for all the major health problems that we face.”
The WHO, he said, will train manufacturers in the six chosen African countries, and the Medicines Patent Pool will help in managing intellectual property and licensing.
South African President Cyril Ramaphosa said the operation of the hub has been affected by intellectual property barriers and failure by other companies to transfer technology to the hub.
He called on big buyers of vaccines, including Covax and Gavi, the Vaccine Alliance, to consider buying from local manufacturers instead of purchasing them elsewhere and selling them on the continent.
“The local manufacturer will majorly be affected by lack of market for the vaccines after production. Let’s make this our baby and grow it together. That way we are going to sustain the hub,” the President Ramaphosa said.
He also called for the swift approval of the TRIPS waiver, which would ensure that intellectual property isn’t a barrier to access to health products during a pandemic.
Prof Charles Gore, executive director at the Medicines Patent Pool – a United Nations-backed public health organisation working to increase access to and facilitate the development of life-saving medicines for low- and middle-income countries – said the project will change the profile of the continent.
African member states have been asked to support the project by buying the end products. “We got to do things differently. We have to be better prepared,” Prof Gore said.
“This is going to be a game changer. And there is definitely political will to make this happen. If this project succeeds and produces the end product, then definitely the attitude that Africans can’t do it will have to change.”
Africa, he said, is disadvantaged with few manufacturing companies, lack of skills, poor infrastructure, poor development programmes, unemployment and a high cost of moving goods from one country to another.
“From the hub, we can develop our skills, sell our own medicines across the continent [and] employ African researchers … The project has attracted good funding and we must make it work,” Prof Gore said.
He added that long-term commitments are needed to build capacity in poor countries by ensuring equity and maintaining a worldwide network of collaboration, including scientists and institutions, to develop vaccines and drugs in the long term and be prepared for future pandemics.
Dr Lul Riek, Africa Centre for Disease Control regional coordinator, said Africans rely too much on wealthy countries to take care of their health.
“A case in point is a Covid-19 outbreak. This was a lesson enough for countries to see the need of supporting each other and building the hub, which will go a long way in benefiting the continent,” Dr Riek told reporters at a gathering on pandemic preparedness.
“We have the resources, all we need is to put our heads together and get prepared for any future pandemics.”
Prof Terblanche warned that unless a pipeline of products is developed, mRNA may become redundant.
“We have been approached by leading scientists in the HIV community … with clinical HIV candidates in development wanting to work with mRNA,” she said.
“So we need to build the pipeline. We need to build a platform for vaccine innovation while looking at new disease targets.”
Ms Winnie Byanyima, executive director of UNAids and co-chair of the People’s Vaccine Alliance, said: “How can we now, each time there is a pandemic, have to wait for reverse engineering; do we have to go through this process again?
“So that's why I keep saying that to fight and end Aids, to fight other pandemics, we must confront the rules that are rigged against ordinary people from poor countries. We must fight.”