mRNA Technology Transfer Programme – A Systems Thinking Approach
10 March 2023
– By Mmboneni Muofhe, Deputy Director-General at the Department of Science and Innovation (DSI)
When Covid-19 hit, low- and middle-income countries (LMICs) were left behind regarding access to vaccines. We all started talking about how to build capacity so that developing countries have equitable access in the future, and to never again see such inequities. Everyone was eager, which was terrific, but quite quickly, it became clear that a coordinated approach was required and that not everybody had the capacity to do it on their own. It was clear that there were many moving parts and that we cannot just do one thing on our own and hope that others will fall into place. The World Health Organization‘s vision in 2021 of bringing together a network of partners and creating the mRNA Technology Transfer Programme is exemplary; together with Medicines Patent Pool, they have paved the way. The Programme relies on partnership and working together with scientists, industry, the global health community, governments, and communities, among others. We need a whole ecosystem and need to make sure that the ecosystem can function the way it is supposed to.
In just over 18 months, we have all been working hard, pushing the boundaries to achieve our collective ambition of equitable access to regionally develop and produce mRNA vaccines in LMICs. We are looking beyond Covid-19 to other disease areas where we can use the mRNA technology platform. We want mRNA vaccine research for tuberculosis, malaria and HIV and other diseases that affect LMICs. It is true that, at times, progress towards this vision seems slow. Sometimes I get caught up in the details of our work, and it can feel like we are in a washing machine; we go round and round trying to address critical gaps that, at times, feel insurmountable. It is unavoidable that there are moments of wonder because, despite our progress, there are still many gaps.
Identifying those gaps has also been our strength and our ability to build solutions. What I like so much about the mRNA Technology Transfer Programme is the systems thinking approach which says we need to look at all the parts that make the whole, and actually make the whole work. We come together to address the challenges one by one. Already we are working with the manufacturers in the 15 countries currently included in the Programme. The level of assistance that we need to provide is different for each, which is why the Programme has sequenced the companies to know the level of support required. Some have started receiving technology transfer training, while others are still putting the building blocks in place. We are looking very closely at local manufacturing in these countries because in providing companies with the capacity to develop and make vaccines, they become the bedrock of ensuring true ownership instead of imposing a technology from somewhere without local capability. Through our close engagement with countries, we identified what sort of schemes are required and the people who need to be trained through comprehensive programmes in South Africa at Afrigen, and the global biomanufacturing training hub in South Korea led by the International Vaccine Institute.
Once the vaccines are closer to being available, there will be regulatory hurdles. A strong point of the Programme is that it includes strengthening regulatory aspects, not only in South Africa but in all the countries that are part of the Programme. Finally, we must have markets for these vaccines, and we must now work closely with governments and communities so that the markets are ready, and the ground is prepared for procuring vaccines when the day comes.
Today in South Africa, we are building a solid local ecosystem, which includes the Department of Science and Innovation and the Department of Health. I am saying this because it raises the issue of what has been very helpful in terms of leadership and government backing in building capacity. Equally important is engaging with our funders, who continue to show tremendous support. At times we have had to turn to the highest office in the land and say, “We now need your intervention,” and our leaders, President Ramaphosa of South Africa and President Marcon of France, who stand out among others, have been ever present in voicing that support. Strong political support remains essential, and I thank our leaders for being there when we need them.
Our efforts are being rewarded. Afrigen has the first mRNA vaccine candidate developed from concept to proof of concept that is now in pre-clinical studies – AfriVac 2121 in recognition of its origins (Africa) and the date of the announcement of South Africa as the Hub (21 June 2021) is the vaccine we are proud of, and Phase -1 clinical trials are on track to start later this year. To date, twelve companies have signed MOUs, and we have begun the technology transfer training. Despite the gaps, we have a way forward, and I thank all of you in the ecosystem for this. My final message is, I urge you to please be patient with us. We are all doing our best. Our goal is getting this Programme to the finish line; the signs are promising, and each day, we are a little closer.