The government's ambition to see large-scale local production of vaccines relies on intellectual property rights waivers, but even then we probably lack the required infrastructure.
South Africa is still in its infancy when it comes to being able to develop and manufacture vaccines, despite leading the charge on the continent.
The government’s ambitions to see large-scale local production of vaccines relies heavily on a proposed agreement among developers to waive intellectual property rights for Covid-19 vaccines and medicines in poor countries.
In his weekly statement this Monday, President Cyril Ramaphosa says South Africa plans to rapidly scale up local production of its Covid-19 vaccines if the proposal supported by South Africa, India and the US is accepted at the World Trade Organisation.
According to Jeff Dorfman, associate professor of the Division of Medical Virology at Stellenbosch University, South Africa could not have been ready to produce vaccines in meaningful quantities in the time it has had.
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“This capacity was not pushed quite early enough for us to be in the game already and make a difference now,” he said.
Local vaccine manufacturers and distributor Biovac announced a partnership earlier this year to produce a vaccine made by life sciences company ImmunityBio that is still in the early stages of testing.
Hope for South Africa entering the global vaccine manufacturing sector in earnest also lies in the multibillion-rand agreement that will see Aspen Pharmacare produce more than 300 million doses of the Johnson & Johnson vaccine over the next three years from the former’s specialised plant in Gqebera, Eastern Cape.
But as Ndlovu Care Group CEO Dr Hugo Tempelman points out, this activity will only deal with the packaging of the product. He suggests venturing into full scale production may be seen as too risky an investment in South Africa.
‘If you look at Aspen, for example, and its deal with Johnson & Johnson in Port Elizabeth, the material for the vaccine production is not made here. The bottling and creation of the vials is done here. But even with just that, the estimated R4.5 billion that will be invested will probably be one of the largest investments in pharmaceuticals we have seen in a long time, if not ever.’
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According to the World Health Organisation, South Africa is one of only five countries on the continent with local vaccine production capacity. Upstream production on the continent is low and most local companies’ activities are limited to packaging the finished product.
Professor Robert Bragg of the University of the Free State’s school of Microbial Biochemical and Food Biotechnology, suggests South Africa does have some capacity for producing vaccines as has been demonstrated in the local production of paediatric vaccines, but a lack of funding in the research and development stage is an important hindrance.
“The company, Biovac, also has vaccine manufacturing capabilities, but is limited in its ability to produce cell culture-based vaccines. It is geared to bacterial based or yeast based vaccines. All of the current Covid-19 based vaccines are cell culture based,” says Bragg.
Bragg is part of a research group that has a patented yeast-based expression system. In March 2020 the team had already designed the genes for expression of the Covid-19 virus in their expressions system.
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“The design of the genes for SARS-CoV-2 was based on the work we did with the avian coronavirus. We attempted to publish this work in March 2020, but one of the reviewers requested that we first express the genes before we could publish. Due to a lack of funding we could not move forward to the expression of these genes. We have only been able to scrape some funding together to start on this work in 2021.”
According to Bragg, the university also has a project on the expression of the South African variant of SARS-CoV-2 and the Wuhan strain in order to first show proof of concept so it can move forward on its discussions with a local vaccine manufacturer.
As soon as proof of concept has been demonstrated with the two strains being researched, Bragg says it would be relatively easy to roll out the technology for other variant SARS-CoV-2 viruses.
Tempelman traces South Africa’ s local vaccine manufacturing to the last decades of apartheid when South Africa was eventually forced by a global sanctions to produce paediatric vaccines.
Investment in the sector shifted heavily away from manufacturing when those sanctions were lifted.
“When the transition happened a lot of those investments were not being made any more and we did not keep up with developments,” says Tempelman.
“What is hampering development now is the tendering system. You need the infrastructure and the knowledge to develop vaccines. Knowledge is there, but there is no infrastructure. If you want to develop a vaccine that you can only secure a two-year contract from the Department of Health for a certain line of production, then the risk of not being able to continue afterwards is too high.”
Criticism of South Africa’ s lack of investment in vaccine development and manufacturing, in light of the Covid-19 pandemic, may not take into account how much South Africa already contributes to the global vaccine race. So suggests Dr Mmboneni Muofhe, deputy director-general of technology innovation at the Department of Science and Innovation.
He suggests that South Africa’s role in the development of Covid-19 vaccines may be underestimated, because many of the finished products arriving in SA have been developed with the help of South Africa’s leading scientists during various stages of the process.
“For example, we talk about the Pfizers and Astra Zenecas of this world, but the reality that some overlook is the infrastructure with which these companies manufacture vaccines is not necessarily theirs and in many instances, it is government infrastructure,” he says.
“So what people are talking about with this whole concept of vaccine nationalism fails to recognise there are various steps involved in the development and manufacturing of a vaccine. Making sure that it is working and registered is done by multiple players.”