This technical note accompanies
“8 reasons why countries disagree over a WTO intellectual property waiver”
“The proposed COVID-19 intellectual property waiver: too soon to predict”
“WTO COVID-19 waiver: does the new draft move the talks forward?”
By Peter Ungphakorn
POSTED FEBRUARY 19, 2022 | UPDATED JUNE 3, 2022
“The first factory in Africa licensed to produce Covid-19 vaccines for the African market has not received a single order and may shut down that production line within weeks if the situation doesn’t change, according to executives of the company, Aspen Pharmacare,” — the New York Times, May 12, 2022: “Africa’s First Covid-19 Vaccine Factory Hasn’t Received a Single Order”
“Six months later, the factory is on the brink of closure because of lack of demand” — the Financial Times, May 30, 2022: “Why Africa’s first Covid vaccine factory struggles to find customers: With high prior rate of infection and apathy, demand is dwindling for jabs on the continent” (paywalled).
On February 3, 2022, Nature reported that the South African vaccine hub of the World Health Organization (WHO) had successfully reproduced a COVID-19 vaccine similar to Moderna’s. 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 in South Africa.
Then on February 18, 2022, the WHO announced that six African countries would receive technology transferred from the South African hub — Egypt, Kenya, Nigeria, Senegal, South Africa itself and Tunisia. This would allow them to produce vaccines based on messenger ribonucleic acid technology (messenger RNA or mRNA), the type used in 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 “hub” is the centre for research and development. The resulting technology is then transferred for manufacture at the “spokes”.
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 Cape Town.
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 multi-agency COVAX, which describes itself as a global risk-sharing mechanism for pooled procurement and equitable distribution of COVID-19 vaccines.
The South African hub has developed mRNA vaccine production at laboratory scale based on Moderna’s technology. 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.
This vaccine might arrive too late to have a major impact on the COVID-19 pandemic, he told told BBC Radio 4’s The World Tonight on February 18, 2022 (from 18 minutes in). 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 and tuberculosis.
The “hub-and-spokes” approach means the vaccine technology is developed in South Africa. It is then transferred to other countries through training and other ways of sharing know-how so that they can manufacture the vaccines themselves. In Africa, the first “spokes” will be in the six African countries announced on February 18. 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 to supply enough vaccines for developing countries. The South African hub is a first step at getting round the problem.
According to the Medicines Patent Pool’s VaxPal database of COVID-19 vaccine patents, Moderna does not appear to have any patents registered or applied for in any of the six African countries except South Africa, where it has seven patents for its vaccine. It has none in Argentina, and two (one not yet granted) in Brazil. By contrast, Moderna has about 50 patents granted in the United States, all related to its mRNA vaccine.
However, VaxPal cautions that its database uses available information, which is not necessarily complete.
“In most developing countries, the information on whether patent applications
for [COVID-19 vaccine patents] have been made or not remains unavailable,” write Ting-Wei (Alex) Chiang and Xiaoping Wu in a WTO Secretariat staff paper that uses the database to analyse patents on 10 main vaccines.
June 3, 2022 — adding update box with links to New York Times and Financial Times reports
Cape Town | Pieter van Noorden, Unspalsh licence