The lack of vaccine production capacity in African countries has been the subject of much concern and criticism in the wake of the COVID-19 pandemic. It has become a particularly hot topic due to the severely unequal access to COVID-19 vaccines between developed and developing countries.
Africa has limited vaccine production capacity. Only Tunisia, Senegal, Egypt, Ethiopia and South Africa have varying capacities to produce and fill or complete vaccines. The largest and most integrated institution is the Biovac Institute in Cape Town.
Recently, Pfizer signed a letter of intent with the institute for 100 million doses per year. The agreement covers the import of the drug substance in bulk, the filling of the vials and the distribution of the product in Africa and elsewhere.
The shortage of manufacturing capacity in Africa contrasts sharply with developing countries such as India, which has significant pharmaceutical production capacity, and Brazil.
This is why the recent announcement by the German biotechnology company BioNTech of the construction of a vaccine manufacturing plant in Rwanda, to be followed by a second in Senegal, is seen as a turning point.
The BioNTech plan involves the construction in Germany of a containerized manufacturing unit which will then be installed in Rwanda, shortening the construction period of a vaccination facility by at least one year and reducing the risk of delays. Initially, the facility will be managed and operated by BioNTech staff. But ownership and expertise will transfer over time to local operations. At present, such expertise does not exist in Rwanda and, based on Biovac’s experience in South Africa, could take a decade to develop.
To make a vaccine, you need intellectual property as well as know-how. The deal between BioNTech and the two countries includes a technology transfer – this will happen in the second phase of the contract – and a licensing agreement that covers the intellectual property rights that will remain with the company.
There are no further details on either facility. It is still unclear, for example, when the locally produced vaccine will be marketed and how the infrastructure will be funded.
Nevertheless, the agreement with Rwanda is unique. Indeed, for the first time, the drug substance or active ingredient of a COVID-19 vaccine – in this case mRNA – will be manufactured on the continent. COVID-19 vaccine mRNA is currently only manufactured in the United States and Europe.
Recent experiences with vaccine availability in developing countries clearly show that local manufacture increases the likelihood of vaccine coverage. This was true in India and China, both of which have significant local capacities.
The level of vaccination against COVID-19 in Africa is low. Only 60 million of the total population of 1.22 billion, or 5%, had been fully immunized by the end of September 2021.
Several tens of millions of doses are missing on the market. There is also no sign that this shortage will be overcome before mid-2022.
MRNA vaccines use small amounts of the active substance. Less than 50 kg of mRNA will be needed to vaccinate everyone on the African continent.
However, local vaccine production is not just a question of manufacturing technology. The operation will require the establishment of a regulatory drug approval system and a quality assurance system that will be able to certify each production batch.
Clearly, the pressure on pharmaceutical companies to expand COVID-19 vaccine coverage to Africa is part of the driving force behind this announcement. But the market could have been more easily supplied directly from BioNTech’s facilities in Germany and elsewhere. Without a doubt, part of the rationale for this deal is the pricing structure for African countries.
Pharmaceutical companies are careful to protect their high value-added markets, where drug prices are high and margins extremely attractive, against any product that can be distributed under an “access price”. Access pricing is a mechanism by which developing countries can purchase equivalent products at significantly reduced prices.
But problems arise when the product becomes available in lucrative markets as a result of parallel importation.
Parallel imports can be avoided by using geographically separate manufacturing sites, operating under different regulatory regimes. A product made in Rwanda and approved by a Rwandan regulatory authority would not be accepted in Europe or other developed regions.
Pharmaceutical companies can thus respond to criticism from the world community in terms of access to health products, while maintaining their profit margins in the most lucrative segments.
The end of the game
The hope is that the deal will benefit the development of vaccine manufacturing capacity across the continent. One possibility is that the BioNTech deal puts pressure on countries like South Africa to speed up their manufacturing plans, leading to greater availability of vaccines over a shorter period.
South Africa has so far dominated vaccine deals. In addition to the Pfizer contract, it also announced an mRNA vaccine hub. This will be used to develop and license mRNA technologies from large pharmaceutical companies.
The price, however, is end-to-end local manufacturing with full technology transfer and fewer restrictions on market access.
This will be crucial to eliminate global inequalities in the provision of essential health commodities.
Another factor could also come into play: a change in the pharmaceutical manufacturing landscape. The agreement reached by BioNTech is the first to be concluded independently of its partnership with Pfizer. This is a signal to the market that BioNTech intends to develop its own customer base outside of its licensing agreement with Pfizer. This is important because Pfizer has made it clear that it is not interested in releasing basic expertise on how to make the active ingredient for COVID-19 vaccines.
ABOUT THE AUTHOR
David Richard Walwyn is Professor (Engineering and Technology Management) in the Graduate School of Technology Management, Faculty of Engineering, Built Environment and Computing, University of Pretoria. He also runs a small company, Reseva, which provides consulting services in innovation strategy and management, science policy, feasibility studies, program evaluation and research management. He previously worked as director of research at CSIR, as CEO of a small biotechnology start-up (Arvir Technologies), director of commercialization of iThemba Pharmaceuticals, CEO of eGoli Biotechnology Incubator, director of research (development process) at AECI, and in various capacities in other chemical companies. In his academic work, he teaches a course on research methodology and undertakes research on renewable energy technologies, transitions to sustainability, innovation management, health economics and technology localization. , where the latter covers the transformation of the South African manufacturing sector from its dependence on resources to high-value products and services. It also supervises 2 doctoral students and 20 master’s students.
This article is courtesy of The Conversation.