The Department of Health, in partnership with the Department of Science and Innovation, convened a multi-stakeholder forum yesterday as South Africa prepares to lead Africa’s COVID-19 vaccine manufacturing drive through its mRNA technology transfer hub.

These exciting developments come at a time as COVID-19 cases, fuelled by the Omicron variant, continue to rise.

SA ‘well positioned’

Director General of the National Department of Health and public health practitioner, Dr Sandile Buthelezi, said that SA is well positioned to lead the initiative.

“We have existing facilities to pilot. South Africa has had a relationship with Biovac since 2013 to establish local vaccine manufacturing capability. We have a strong and capable regulatory authority that could support good manufacturing practices and ensure compliance.”

#HappeningNow – Forum on #mRNA Vaccines Technology Transfer Hub
🎙️@WHO's Martin Friede walks us through the governance of the #mRNA Vaccines Technology Transfer Hub and the anticipated timeline for the 🇿🇦 Hub.
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Buthelezi acknowledged the challenges that contributed to the slow vaccination rollout.

“We started off with constrained supply followed by increased supply. We also face a widening gap between developing and developed countries which are impacted by the global supply chain crisis. And this is really a threat to initiatives like this one. The COVID-19 pandemic has thus provided us with opportunities to strengthen the provision of health care, increase access and improve health outcomes,” he said.

Buthelezi noted with confidence that the recent discovery of the Omicron variant by SA scientists is a reflection of their expertise to harness science and produce research-based evidence against vaccines.

SA’s mRNA vaccine technology transfer hub

Cape Town has been chosen as a testament to the quality of SA’s scientific expertise.

“The South African hub will involve an end-to-end development of mRNA placed vaccines. This will serve as a vaccine training facility where technology is established at industrial scaling and clinical development is involved. The trading center will be established as part of the current good manufacturing practices clinical trial production facility to support vaccine development and the commercial manufacture of an mRNA vaccine. It will also ensure sustainability of the technology transfer,” explained Deputy Minister for Higher Education, Science and Innovation, Buti Manamela.

Manamela said that full use will be made of South African technical expertise in genomics immunology, vaccine manufacturing and clinical trials –  feeding the pipeline for local manufacturing.

Low and middle income countries will benefit

This also means that manufacturers from low and middle income countries will be able to receive training at the hub, as well as technology licences.

He added:“the program will transfer sufficient know-how to enable manufacturers in these countries to successfully manufacture vaccines at scale. Thereby, supporting further clinical development, national and regional marketing authorizations, with sustainable supply to meet local and regional demand.”

Initial mRNA vaccines are modeled on open source technology. This provides assurance that the hub will in no way be involved in the misuse of intellectual property.

“The Medicines Patent tool – which is responsible for the intellectual property, and licensing elements of the project – will ensure that patents are not infringed upon. The hub will utilize the results of ongoing research to ensure an improved vaccine that is safe and effective,” concluded Manamela.

Bio manufacturing training centre

Africa will enter phase one of the clinical trials with their technology by the end of next year.

Dr Martin Friede, Coordinator of the World Health Organization’s Initiative for Vaccine Research, acknowledged that there is a lack of a skilled workforce in bio manufacturing.

“This affects technology transfer into low and middle income countries. So, we will launch a bio manufacturing workforce training center,” said Friede.

One of WHO’s objectives is the development of local innovation and products. Friede added that the budget adds up to about 92 million euros.

“It is really important that South Africa tries to make new vaccines made in Africa for Africa. We are confident that we will be able to meet the financial objectives. We’ve got some of the best scientists on earth helping us and the South African infrastructure is excellent. Everything is in place for this to work,” said Friede.

Lessons learned

President and CEO of the South African Medical Research Council (SAMRC), Dr Glenda Gray, reflected on the lessons learned from SA’s history in fighting infectious diseases as well as HIV vaccine research and clinical trials.

“We now have great expertise in pre-clinical and clinical vaccine development and research. The HIV epidemic pivoted our resources to be able to respond to the pandemic in a rapid fashion. Learning to work together, with scientists, as well as, clinicians, maximized our support of pandemic preparedness. It is important that we use this mRNA hub not only to helps us respond to COVID-19, but also to help us with TB and HIV vaccines in the future,” she said.

The SAMRC will support the project developments and the fundraising aspects of this initiative.

Gray noted that they are looking forward to working with the departments to ensure the accurate response to the immediate problems caused by the pandemic and also not neglect diseases like HIV and TB in their endeavor to support the health work of the continent. –  Health-e News