Research Explained

Can Africa Make Its Own mRNA Vaccines Without Waiting for the West?

When Moderna declined to license or assist with its mRNA vaccine technology in 2021, Afrigen Biologics in Cape Town reverse-engineered a version anyway, without Moderna's involvement. Five years on, Afrigen has become the first African facility certified to manufacture experimental biologics for human trials.

Illustrative laboratory photograph, not Afrigen's own facility. Photo: ThisIsEngineering/Pexels.

During the COVID-19 pandemic, almost none of the world's mRNA vaccine manufacturing capacity sat in Africa. Doses arrived on the continent later than almost anywhere else, largely because the companies that owned the technology controlled where it was made. In 2021, the World Health Organization set out to change that permanently, not by asking those companies for help, but by building a manufacturer from nothing. It picked Afrigen Biologics and Vaccines, a small biotech in Cape Town few outside South Africa had heard of. Afrigen's plan was to base its first product on the best-understood mRNA vaccine in the world, Moderna's COVID-19 shot. Moderna declined to help.

Afrigen built one anyway, without them.

How do you copy a vaccine without the company that made it?

The genetic blueprint for Moderna's vaccine had already surfaced in published patent filings and scientific literature, filed as part of the normal process of seeking intellectual property protection. Afrigen's scientists, working with the Medicines Patent Pool and the University of the Witwatersrand, used that public information to design their own version of the vaccine from scratch. It was reported at the time as a reconstruction built without any cooperation from Moderna itself, relying on published science rather than a shared formula or transferred cell lines.

What does the hub actually do, beyond one company?

Afrigen was never meant to be the whole programme. It is the anchor of the WHO's mRNA Technology Transfer Programme, coordinated from Geneva by the Medicines Patent Pool, which exists specifically to move what Afrigen learns out to other manufacturers rather than leaving the knowledge sitting in one facility. An initial announcement in February 2022 named Egypt, Senegal, Kenya, South Africa, Tunisia and Nigeria as the first recipients. The network has since grown to 15 partner organisations across low- and middle-income countries, each intended to build its own manufacturing capacity rather than remain dependent on the hub indefinitely. The logic behind spreading the knowledge this widely, rather than concentrating it in one country, was that a pandemic does not wait for a single factory to scale up, and a continent that can only point to one manufacturer has not actually solved the problem the hub was built to fix.

Why "failure was not an option" for Afrigen

On 27 May 2026, South Africa's health products regulator, SAHPRA, certified Afrigen under Good Manufacturing Practice standards, the first African facility cleared to manufacture investigational biological products for Phase I and II clinical trials. It came nearly five years after Afrigen was selected in 2021, years spent building laboratories, training staff and satisfying a regulator that had never certified an mRNA facility before. "Failure was never an option," said Professor Petro Terblanche, Afrigen's chief executive, while crediting support from the WHO, the Medicines Patent Pool and international donors. Charles Gore, head of the Medicines Patent Pool, called the path from concept to regulated manufacturing "mindboggling." WHO Director-General Tedros Adhanom Ghebreyesus called it "an important milestone not only for South Africa and the African continent, but also for global health." A certificate alone does not make a vaccine. It means Afrigen can now legally produce experimental doses for the human trials that would prove whether one works.

Is the underlying model actually sound?

Not entirely, according to the programme's own independent scrutiny. A 2024 study by Matthew Herder of Dalhousie University and Ximena Benavides of Yale University examined the mRNA hub and found it largely mirrors the same power imbalances it was built to fix. The programme, they wrote, imposes no binding pricing requirements on most products: "apart from requiring IP sharing inside the programme, the architects opted not to stipulate terms of affordability." Control also stays centralised in Geneva rather than with the manufacturers doing the work; one participant they interviewed put it bluntly: "You do not have a remote group that does tech transfer." The study also warned that bilateral deals between individual partners and outside pharmaceutical firms could fragment the network before it fully forms, each partner striking its own arrangement rather than the network growing as a whole.

What happens next?

Afrigen has moved well past COVID-19. With $6.2 million in funding from the Coalition for Epidemic Preparedness Innovations, it is now developing an mRNA vaccine against Rift Valley fever, a livestock and human disease with no licensed human vaccine anywhere in the world. The company is also moving toward a non-profit structure in partnership with South Africa's Medical Research Council, a shift aimed squarely at the problem Herder and Benavides flagged. Newly certified manufacturers like Afrigen will likely face higher production costs than established pharmaceutical firms already supplying global markets at scale, and nothing so far guarantees that governments or aid agencies will actually buy what the hub can now make. Manufacturing the vaccine and finding a buyer for it are different challenges. Only the first has been solved.

Institutions in this article: Afrigen Biologics and Vaccines, South Africa; Medicines Patent Pool; South African Health Products Regulatory Authority; University of the Witwatersrand.

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