This technical note accompanies
“8 reasons why countries disagree over a WTO intellectual property waiver”
See also:
“Why Africa’s first Covid vaccine factory struggles to find customers” Financial Times
“Why Africa’s Covid vax plant failed to take off” The Statesman
“Aspen debacle shows global vaccine funds must buy African” African Business
By Peter Ungphakorn
POSTED FEBRUARY 19, 2022 | UPDATED JUNE 17, 2022
On February 3, 2022, Nature reported that the South African mRNA vaccine hub of the World Health Organization (WHO) had successfully copied Moderna’s mRNA COVID-19 vaccine. This was achieved without a WTO intellectual property waiver because the scientists used publicly available information and Moderna said it would not enforce its patents — in effect Moderna voluntarily waived its own patents.
Still in early stages, the breakthrough would take some time to turn into industrial scale production, and before completing the trials needed for the vaccine to be approved medically and marketed.
Then on February 18, 2022, the WHO announced that six African countries would receive technology transfer from the South African hub — Egypt, Kenya, Nigeria, Senegal, South Africa and Tunisia. This would allow them to produce vaccines based on messenger ribonucleic acid (messenger RNA or mRNA) technology, the type used for Moderna and Pfizer/BioNTech vaccines.
The move is part of the WHO’s programme to create a “hub and spokes” for vaccine production in developing countries, particularly in Africa, where the big pharmaceutical companies have been reluctant to set up production themselves.
The creation of the mRNA vaccine technology hub in South Africa was announced on June 21, 2021. It involves a consortium of South African companies and universities, and is set up at Afrigen Biologics and Vaccines in Capetown.
The Medicines Patent Pool (MPP) is providing support on intellectual property, licensing, negotiating with technical partners, and the hub’s governance. Additional support comes from the WHO’s Access to COVID-19 Tools (Act) Accelerator and COVAX, a “global risk-sharing mechanism for pooled procurement and equitable distribution of COVID-19 vaccines”.
The South African hub has developed mRNA vaccine production based on Moderna’s technology at laboratory scale. The next step would be to expand production to industrial levels, and to go through clinical testing, from the fourth quarter of 2022 so that it can eventually be approved.
The WHO and scientists involved in the project estimate that approval for general use could be achieved in 2024. This is slow because although Moderna is not enforcing its patents, it has not actively shared its technology or test data.
The South African vaccine would be available for general use considerably sooner if Moderna did cooperate actively, according to Tulio de Oliveira, director of the Centre for Epidemic Response and Innovation at Stellenbosch University.
He told told BBC Radio 4’s The World Tonight on February 18, 2022 (from 18 minutes in), that this vaccine might arrive too late to have a major impact on the COVID-19 pandemic. De Oliveira said that the hub’s main value would be in developing vaccines for diseases that the big pharmaceutical companies ignore, such as ebola, zika, dengue, rift valley fever, HIV or tuberculosis.
The “hub-and-spokes” approach means the technology is developed in South Africa and then transferred to other countries through training and sharing knowhow so that they can produce the vaccines developed at the hub. In Africa, the first “spokes” will be in Egypt, Kenya, Nigeria, Senegal, South Africa itself, and Tunisia. The WHO says “spokes” are also being created in Brazil and Argentina.
“Once a vaccine has been successfully developed, the spokes will mass-produce the vaccine for national and regional use. Each spoke will need to seek approval in their jurisdiction, which will be facilitated by the sharing of the full pre-clinical and clinical data from the hub,” the WHO says.
Whether the manufacturing “spokes” eventually develop into research and development “hubs” in their own right remains to be seen.
The WHO has repeatedly criticised the pharmaceutical companies — including Moderna and Pfizer/BioNtech — and rich countries for failing to share their technology and supply enough vaccines for developing countries. The South African hub is a first step at getting round the problem.
See also analysis by Priti Patnaik (Geneva Health Files) and Alan Beattie (Financial Times.)
Updates:
June 17, 2022 — this page was deleted in error and has been recreated from original notes. It might not be identical to the original
Image credit:
Main picture, Cape Town | Pieter van Noorden, Unspalsh licence
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