The first “technology transfer hub” for messenger RNA COVID-19 vaccines will be established in South Africa to scale up production of and access to doses across the African continent, which has vaccinated less than 1% of its population.
The new hub, which the World Health Organization announced on Monday, will provide training on mRNA technologies for manufacturers from low- and middle-income countries and license them to move forward with local production.
But the hub still needs to secure agreements with mRNA vaccine manufacturers, and these efforts are not a substitute for a waiver of the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights, or TRIPS, according to health officials.
“We just cannot continue to rely on vaccines that are made outside of Africa, because they never come. They never arrive on time, and people continue to die,” said South African President Cyril Ramaphosa during a press conference.
Currently, two COVID-19 vaccines using mRNA technologies have proved safe and highly efficacious: one developed by Pfizer and BioNTech and another by Moderna. This type of technology induces cells to produce a protein, or a piece of a protein, that triggers an immune response in the body.
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The benefit of this technology, which has been in development for decades, is that it is potentially easier to scale than alternatives and could be faster and easier to adapt for COVID-19 variants of concern, said WHO Director-General Tedros Adhanom Ghebreyesus.
If knowledge of the way to produce an existing mRNA COVID-19 vaccine is transferred to this new hub in South Africa, doses could be produced at the site in the next nine to 12 months, said WHO Chief Scientist Soumya Swaminathan. A facility already exists there, but the hub needs to purchase equipment, train the local workforce, and source the raw materials.
However, this process could take longer if the hub instead receives the know-how for a vaccine that is still in development, as clinical trials would need to be completed, she said.
“It’s much easier to transfer a technology that’s proven, that’s gone through clinical trials, [and] that’s proven to be safe and efficacious,” Swaminathan said.
She said Uğur Şahin, chief executive officer at BioNTech, has committed to building capacity for manufacturing his company’s vaccine in Africa.
WHO is “in discussions with the larger companies that have proven mRNA technology, and we are hoping very much that they will come on board,” Swaminathan said.
Ramaphosa said that while the establishment of this hub is a step in the right direction, a TRIPS waiver is still necessary to quickly increase access to vaccines.
Intellectual property becomes a barrier when patents are filed domestically, Swaminathan said. The agency is not aware of any such hurdles related to mRNA technologies on the African continent or in lower- and middle-income countries located elsewhere, she said. However, these kinds of issues could arise in the future.
“We don’t believe that, currently for the hub planned in South Africa, that there’s going to be a major barrier,” Swaminathan said, but delays could occur if intellectual property protections block a vaccine ingredient or component. Thus, a TRIPS waiver could make the process smoother.
“We just cannot continue to rely on vaccines that are made outside of Africa, because they never come.”
— South African President Cyril RamaphosaThe hub is spearheaded by WHO; partners in the international COVAX initiative; South African companies such as Biovac — which will serve as a vaccine developer — and Afrigen Biologics and Vaccines, which will serve as a manufacturer; universities; and the Africa Centres for Disease Control and Prevention. The Medicines Patent Pool is helping WHO negotiate with technical partners and supporting governance of the hub.
“It is possible to make enough mRNA vaccines for the world within a year. [U.S.] President [Joe] Biden and other leaders should offer funding, technical capacity and political support to share vaccine recipes and accelerate WHO’s plans to make a difference not only against future pandemics, but also against COVID-19 today,” said Peter Maybarduk, director of Public Citizen’s Access to Medicines Program, in a press release.
This hub is expected to yield results in the medium term but won’t provide a new influx of doses in the short term, said Dr. Mike Ryan, executive director of the emergencies program at WHO.
“It will not deal with the immediate problem, which is getting vaccines into people now,” he said.
Update, June 22, 2021: The new technology transfer hub was announced by WHO on Monday.