South African pharmaceutical company Afrigen is the first on the continent to manufacture a COVID-19 mRNA vaccine using publicly available data from Moderna. The company hopes to begin clinical trials of the vaccine in November.
Afrigen is one of the companies participating in a center supported by the World Health Organization to develop vaccines for low- and middle-income countries. Afrigen chief executive Petro Terblanche said the mRNA vaccine was made with the company’s knowledge base, processes and personnel. She said there was no transfer of technology from a third party.
“The latest development at the Afrigen mRNA Center in Cape Town is that our scientists have taken the Moderna 1273 vaccine sequence released by Stanford University in an open source fashion and formulated a lab-scale drug product. They are currently doing more batches and analytical testing to make sure they have the quality in place, so this is the first full lab-scale candidate vaccine that has been developed,” she said. declared.
Terblanche said the company does not need Moderna’s clearance because its vaccine is still in the research and development stage.
“The footage is released first, second we operate in the R&D space,” she said. “We have complete freedom to operate, an exemption under the Bolar exemption in intellectual property law. So until phase 3 clinical trials, we are completely legal and we don’t need any no permission. Once this product is commercialized and there are intellectual property constraints, we need to obtain a voluntary license for it.”
Terblanche said they would ask Moderna to voluntarily license the vaccine to them, as it would be mutually beneficial for companies and low- and middle-income countries that will use this technology.
She added that they were using the new vaccine as a test case for a second-generation vaccine that is in the design phase.
Moderna has not commented on Afrigen’s announcement, but it was widely reported late last year that the company had suspended a patent dispute with the US government over its coronavirus vaccine.
Moderna had disputed claims that three US government scientists were co-inventors. However, the company said it would not pursue the fight at this time as it did not want to distract from the fight against the pandemic.
Terblanche acknowledged the support of scientists from other countries for Afrigen’s work.
“This is our learning case and we are pleasantly surprised with the results, but the design of the new formulation is already underway with scientists and technical partners around the world,” she said. “It’s not just us, it’s a fantastic partnership with scientists in the US and Europe.”
The Acting Director General of South Africa’s National Department of Health, Dr Nicholas Crisp, welcomed the news of the mRNA vaccine development.
“We are very happy to see that they have ramped up their capabilities very quickly,” he said. “It’s very exciting, it’s very important for the country. It’s one of many facilities we’re working on as a country between the Ministry of Health, Science and Innovation and other partners. So it’s very encouraging.”
The World Health Organization’s regional director for Africa, Dr Matshidiso Moeti, said 11% of Africa’s population is fully immunized and 85% have not received a single dose. She added that 239,000 people in Africa have died due to the pandemic.