Increasing manufacturing capacity for COVID-19 vaccines is one of the biggest challenges we need to address in our common goal to bring this pandemic to an end.
Science has delivered not one but several vaccines that are safe and effective and the goal is ensure fair and equitable delivery to vaccines to those who most need them across the world. However, a worldwide scale up in production is not simple and vaccine technology is highly complex.
I had the opportunity recently to participate at the Africa Health Agenda International Conference during the plenary session “Build Back Better – Health Security Beyond COVID 19”. Seen as key to the future health security for the Continent is increasing local manufacturing capacity in Africa. As a panel we discussed the multiple barriers to quickly ramping up production to meet pandemics including issues relating to the speciality of vaccine manufacturing sites, specific skills needs, needs for incentives for investment, and unknowns around long-term demand for COVID-19 vaccines.
Technology transfer is clearly part of the solution – and R&D pharmaceutical companies have already engaged in the process of transferring know-how for production to local manufacturers in developing countries. Collaborations are taking place on a significant scale. Examples include licensing and tech transfer agreements between AstraZeneca with the Serum Institute in India and Fiocruz in Brazil and between Johnson & Johnson with Aspen Pharmacare Ltd. in South Africa and Biologic E. Ltd. in India.
However, knowledge transfer alone will not solve the problem. Technology transfer cannot operate in a vacuum. What is needed is an established sustainable eco-system for local vaccine production. Many challenges to creating such an eco-system are the same as those that the Continent has faced in advancing local production for small molecules. But three specific issues need to be emphasized in case of vaccine manufacturing:
Firstly, the need for highly specialised equipment. Vaccine manufacturing is a complex process requiring high performance equipment for each stage and for each type of vaccine, that meet strict quality standards. Not forgetting that production sites also need to acquire the necessary GMP standards. What’s more, is not possible to simply repurpose an existing production line, each vaccine requires its own line. This means that should a country have an existing vaccine manufacturing capacity, it does not necessarily mean it can easily retrofit a plant to produce COVID-19 vaccines. Furthermore, in current pandemic situation scaling up the number of manufacturers would not resolve the global shortages of 100 plus raw materials that are needed to make the vaccines and it might just exacerbate these shortages as well as those of vials, syringes and stoppers, etc.
Secondly, the need for skills and human resources. There are also issues around securing a highly trained workforce. Building teams of highly skilled technicians that can interpret the technology transfer, perform the multiple quality checks, keep the machines and production running at maximum yields, takes time, which is unfortunately something that the pandemic does not afford us. As Sai Prasad, President of the DCMVN said recently: “It’s a constant race to have more expertise. And we can never have enough. […] When we are talking about increasing capacities and expertise, it is a futuristic concept, maybe we should think about building it in the years to come. But you know, during 2021, and maybe early 2022, we need to go to where the existing capacities and our existing expertise is”.
Thirdly, creating the right investment environment. Regarding the investment needed to create vaccine production, large amounts of capital are required upfront. However, at the moment there are not enough incentives for investors because of uncertainty around long-term sustainability, policy incoherence between countries and within countries and a lack of common regulatory frameworks. What’s more, vaccines are often produced in large quantities at low prices, creating the necessity of large markets to encourage investment. Therefore, it would be necessary for Africa to take a regional approach to ensure vaccine production was viable. The challenge is exemplified by previous experience. In 2005, the World Health Organization supported the expansion of production capacity for seasonal flu vaccines in 14 countries, including Egypt and South Africa. But the high cost of production relative to demand has meant that many of those plants have shut down since then. This is why it is important to look at the sustainability of investments, to not end up with a lot of dormant sites.
Overall there is a critical need for prioritization of the African national health systems themselves, including investing between 5% of GDP and 15% of public expenditure in health. Government coherence that promotes innovation and developing more skilled manufacturing and innovative workforce will be equally important.
Identifying a pathway forward
There have been some significant recent signs of progress which can help towards creating a positive eco-system on the Continent. These include significant improvements in regional regulatory harmonization, the implementation of an African Continental Free Trade Area, the African Development Bank support for purchasing vaccines for the African Union and the exceptional leadership demonstrated by the African CDC in the COVID-19 response. Hopefully the soon to be established African Medicines Agency will add a further important milestone.
The challenges to broad vaccine manufacturing and potential solutions will be discussed further during the African Union’s upcoming virtual conference, which will focus on creating road map for the continent.
Africa remains key to solving the global pandemic. In the short term, we need to see COVAX rolling out its doses as countries are ready and are able to confirm they are ready to do so. In the medium term activities such as “fill and finish” for vaccines provides an important option for African industry which can be developed further. In the longer term, to increase vaccine manufacturing capacity across Africa, we need to spare no time in developing viable strategy now to put in place a secure and sustainable eco-system for vaccine manufacturing in order to address future pandemics.
