World first, South Africa makes mRNA vaccine using Moderna data

Afrigen Biologics in South Africa has used the publicly available sequence of Moderna Inc’s mRNA COVID-19 vaccine, to make its own version in a world first. Test could begin before the end of the year according to Afrigen’s top executive.
The vaccine would be the first to be produced without the assistance and approval of the developer, and would be the first mRNA vaccine designed, developed and produced at lab scale on the African continent.
The World Health Organization (WHO) last year picked a consortium including Afrigen for a pilot project to give poor and middle-income countries the know-how to make COVID vaccines. The market leaders of the mRNA COVID vaccine, Pfizer (PFE.N), BioNTech (22UAy.DE) and Moderna (MRNA.O), declined agreed a WHO request to share their technology and expertise.

The WHO and the consortium partners hope their technology transfer hub will help overcome inequalities between rich nations and poorer countries in getting access to vaccines. Some 99% of Africa’s vaccines against all diseases are imported and the negligible remainder manufactured locally.

The WHO are keen for the pilot to work after wealthy countries snapped up most of the world’s supplies of vaccines.

Biovac, a partly state-owned South African vaccine producer, will be the first recipient of the technology from the hub. Afrigen has also agreed to help train companies in Argentina and Brazil.

In September, the WHO’s hub in Cape Town decided to go it alone after failing to bring on board Pfizer and Moderna, both of which have argued they need to oversee any technology transfer due to the complexity of the manufacturing process.

Moderna’s vaccine was chosen by the WHO due to an abundance of public information and the company’s pledge not to enforce patents during the pandemic. It’s not clear what will happen after the pandemic ends and whether the company will try to enforce them again.

Charles Gore, Executive Director at MPP told Reuters: “If this project shows that Africa can take cutting edge technology and produce cutting-edge products, this will banish this idea that Africa can’t do it and change the global mindset … this can be a game-changer:”

Under pressure to make drugs in lower-income countries, Moderna and BioNTech have announced plans to build mRNA vaccine factories in Africa, but production is still a long way off.

“We haven’t copied Moderna, we’ve developed our own processes because Moderna didn’t give us any technology,” Petro Terblanche, Managing Director at Afrigen, told Reuters.

“We started with the Moderna sequence because that gives, in our view, the best starting material. But this is not Moderna’s vaccine, it is the Afrigen mRNA hub vaccine,” Terblanche said.

The first vaccine is being made in a micro litre laboratory with the help of the University of the Witwatersrand.

Terblanche said Afrigen was also working on a next generation mRNA vaccine that didn’t need freezing temperatures for storage, required for the Pfizer and Moderna doses, and which would be better suited to Africa, which is often dealing with high temperatures and poor health facilities and infrastructure.

“We will only make our clinical trial batch probably in six months from now, (meaning) … fit for humans. And the target is November 2022,” Terblanche added.

If the company in South Africa is successful in producing mRNA COVID vaccine using Moderna publicly available data, it will be a game changer that could save the lives of countless people across the world whose lives are threatened by the lack of availability to vaccines.

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