By Catherine Jewell, Information and Digital Outreach Division, WIPO
During the COVID-19 pandemic, we saw warp-speed development of vaccines in some parts of the world. But for Africa, the pandemic highlighted the urgent need to build capacity on the continent to develop and manufacture much-needed vaccines. This is something the African Vaccine Manufacturing Initiative (AVMI) has been advocating for over 10 years. In a wide-ranging interview with WIPO Magazine, AVMI Executive Director and co-founder Patrick Tippoo, who is also Head of Science and Innovation at the South African bio-pharmaceutical company, Biovac, explains why vaccine independence for Africa is so important.
Why is it important for Africa to focus on vaccine development and manufacture?
During COVID, we saw that Africa was at the back of the queue, in spite of initiatives like COVAX, which fell short of expectations for multiple reasons. The best way to secure supply is to make it yourself. Then you have full control and can determine when and how much you are going to make and the markets you are going to supply.
Another important consideration is the need for a more diversified global vaccine supply chain so we are not overly dependent on Europe, India and the USA and thereby exposed to the risk that they will clamp down on vaccine exports. Those are the key reasons for building vaccine-manufacturing capacity in Africa.
What will it take to develop a sustainable vaccine-manufacturing ecosystem in Africa?
The question is, why hasn’t it already happened? AVMI has been trumpeting the need to build vaccine production capacity in Africa for some time. The challenge goes beyond getting goods at a competitive price. It’s more about the resilience of our health systems. Governments always have to manage competing priorities and while they don’t deny that pandemics occur, they’re not easily convinced that they’re an immediate threat. And we know the answer to that!
In Africa, prior to the pandemic, the supply of routine vaccines for infant immunization was secure. GAVI and UNICEF have taken care of this exceptionally well, such that 60 percent of UNICEF’s vaccine doses come into Africa. But during the pandemic, the vulnerability of depending exclusively on external sources of supply for COVID-19 vaccines came into full focus.
Accelerated access to know how is what shifts the needle in terms of building vaccine production capacity.
China, Europe, India and the USA were well positioned to respond to the pandemic and to manufacture COVID-19 vaccines, because they had warm facilities churning out routine vaccines on a daily basis. With the operational facilities, the workforce, the quality and regulatory approval systems in place, they could repurpose and scale-up their operations to produce COVID-19 vaccines relatively easily. Therein lies the conundrum. Without building the capacity for routine vaccine production, you will never be ready for pandemics. That’s why we need to build a sustainable vaccine manufacturing ecosystem in Africa for routine vaccines.
So, is there a need to change existing vaccine procurement systems in Africa?
Yes, definitely. It comes down to simple economics. For a company to be sustainable, it needs to make a profit to cover overheads and continue operating. And to generate a profit, it needs to sell product and to sell product it needs a market. Currently, less than one percent of the vaccines used in Africa are made in Africa. Only around 10 countries self-procure vaccines; the others rely on GAVI and UNICEF. So we need to look in three directions. We need to look at the dominant position GAVI and UNICEF hold in the African vaccine market. We need to look at the countries that depend on them and we need to look at the countries that self-procure vaccines.
Countries that self-procure vaccines need to implement a coherent strategy underpinned by fully aligned internal policies to support local vaccine manufacture. It’s a challenge because different government departments have competing priorities, but they need to align their efforts to support local vaccine manufacture. Countries that are not yet self-procuring need to signal to GAVI that they want their vaccines to come from African suppliers, as and when these suppliers are ready. GAVI recently published a white paper on the role it can and should play in shaping the African vaccine market. This is a major development. So things are shifting in the right direction.
Are there vaccine manufacturers in Africa with capabilities to do end-to-end vaccine manufacture?
African vaccine manufacturers certainly need to be doing end-to-end production. Most new initiatives and investments in vaccine production have been on the drug product, fill and finish, side of things. This requires less expertise and is easier and quicker to achieve. It’s an important starting point, but we need to continue investing time, effort and money into building upstream drug substance manufacturing capacity and expand on the very limited drug substance capacity we currently have in Africa. For example, the Pasteur Institute in Dakar (IPD) is an end-to-end manufacturer of yellow fever vaccine. Drug substance manufacture also generates more economic value that feeds into the sustainability equation. Biovac and others have plans to build drug substance manufacturing capacity, but I would like to see vaccine product development capability included as well. Because when you know how to develop the product, you own the product and you have full decision-making control over the product.
Technology transfer partnerships are the best mechanisms we have to drive accelerated capacity building.
What role can technology transfer partnerships play in building vaccine production capacity in Africa?
Technology transfer partnerships are the best mechanisms we have to drive accelerated capacity building. They get the ball rolling in the right direction and can help build product development capacity. That is important because it enables you to populate your vaccine-manufacturing pipeline and because it is where the scientific know how and deep understanding of the technology and product is generated.
Can African vaccine manufacturers be cost competitive?
That’s the question! The answer is there is no way African vaccine manufacturers can compete against the economies of scale enjoyed by mature competitors who produce millions of doses of these vaccines. Many of them have been in business for decades and some have amortized their capital investment several times over. The costs for African startups are completely different to those of mature manufacturers based in India or China, for example.
What’s the answer?
We have to introduce what some call a “resilience premium,” on the vaccines we buy, and invest that premium in the development of vaccine manufacturing infrastructure in Africa. That will give African vaccine manufacturers the chance to become part of the global vaccine supply chain.
What can be done then to boost Africa’s vaccine R&D capability?
We need to work from the ground up. We need to work with companies like Biovac (South Africa), Innovative Biotech (Nigeria), and others with proven vaccine R&D capabilities and identify specific projects they are working on and back those projects with funding and technical expertise to drive them to completion. It may take a little longer to see results, but the capabilities will be stronger in the end.
Currently, less than one percent of the vaccines used in Africa are made in Africa.
What are your views on the TRIPS waiver adopted by the 12th WTO Ministerial Conference in July 2022?
Under specific pandemic conditions, it will make a huge difference to access. But accelerated access to know how is what shifts the needle in terms of building vaccine production capacity. And that requires mutual technology transfer partnerships, which are not easy. In transferring mRNA technology, for example, it’s not simply a question of Moderna or BioNTech agreeing to help BIOVAC produce the vaccines. It took the concentrated, around-the-clock effort of a relatively small group of researchers in those companies, to get the first product out. So, from day one, even if they wanted to share their technology, they didn’t have the people to send out to Africa or elsewhere to teach them. It was only as these teams and manufacturing operations expanded that this became an option. So these are some of the logistical realities we have to deal with in technology transfer partnerships in pandemic situations.
What is the role of IP in establishing effective drug manufacturing?
Intellectual property (IP) has a very important role to play. It’s because of IP laws and ownership that there is an incentive to invest in R&D, which carries huge risks. Without IP, such investment will dry up. I don’t see how it would be possible to incentivize investors, manufacturers and developers to risk their time, effort and money without protecting the reward that comes from that.
What in your opinion are the standout developments over the last 12 months in relation to vaccine development?
We have seen that we can rise to the occasion and work together when we need to in a way that we’ve never seen before. We’ve seen how it is possible to work in an accelerated way, without compromising safety, or the quality of the product at all. But we also learned that human nature is human nature and will forever be governed by self-interest. That’s why we’ve got to build a system that enables vaccine independence for Africa.
Tell us about the WHO mRNA technology hub.
The hub was a unique move by WHO to set up a platform for multilateral technology transfers. The aim is to build up mRNA vaccine production-capacity in low- and middle-income countries. The hub is located at Afrigen, in Cape Town in South Africa and is made up of Afrigen, which is responsible for getting the technology out of the starting blocks, the South African Medical Research Council (SAMRC) and South African university groups, which provide the research, and Biovac, the first manufacturing spoke. Biovac will ensure that the technology can be scaled up and will produce the material for the phase three clinical trials. Once the hub establishes the technology and demonstrates its validity, it will share it with multiple partners (or spokes) in other low- and middle-income countries selected by the WHO, for example, in Africa, India and Latin America. The aim is to develop and produce vaccines locally in these countries. The hub seeks to solve the almost universal challenge of access to technology. It is, however, for each company to decide how they’re going to commercially exploit the technology they access through the hub.
How can market access and policy support sustainable vaccine manufacture in Africa?
Market access needs to be shaped by policy and these policies need to incentivize investment and improve vaccine production capacity in Africa. Without these policies, no sustainable production capacity will be built.
It’s because of IP laws and ownership that there is an incentive to invest in R&D, which carries huge risks.
And how long before real tangible results start emerging?
Tangible results are already emerging. We’ve seen Aspen produce vaccine. Biovac has just run it’s first mRNA demonstration batch in its partnership with Pfizer. We are on track to get regulatory approval within months and will start mRNA vaccine production in 2023. Biovac is also producing the hexavalent (6-in-1) vaccine for Sanofi. We have activities in Egypt, Morocco and Senegal, and other countries, like Ghana and Kenya, are putting plans into place.
What impact do you think the recently established African Medicines Agency (AMA) will have?
It has the potential to have enormous impact, especially if, over time, it establishes itself as a credible Pan African regulatory authority and a one-stop shop for the approval of medicines in Africa. We can also expect that vaccines authorized by AMA will be accepted, in future, in other regions of the world as well.
A word for policymakers?
The time to act is now.
How would you like to see things evolve in the future?
As Nelson Mandela said, “it always seems impossible until it’s done.” Prior to COVID-19, it was very hard to convince anybody to pay serious attention to building vaccine manufacturing capacity in Africa. Now, it’s all about how quickly we can do it and how best we can do it – thankfully! I would like to see the day when we’ll be asking what are we going to do next? That’s the paradigm shift we need to see, so that the world not only looks to Europe, India and the US for vaccines, but also looks to Africa. Africa has the potential to play a significant role in contributing to the global vaccine manufacturing supply chain. I’m very optimistic about our future.