Covid vaccine manufacturing in Africa – important, but not the first-line response to this pandemic
Many Africans are, quite justifiably, deeply angered at the inequities in the global distribution of vaccines to combat the Covid-19 epidemic. These replicate existing global inequalities and are key motivations for a multi-pronged push to manufacture the drugs on the continent. However, while some elements of the initiative may pay off in the longer term, full vaccine independence, is a long way off.
The continent is currently (in early July) facing rising infection numbers driven by the spread of the Delta variant at a time when only three percent of its population have received a first vaccine shot. By contrast, at the end of June, Italy, Spain and Germany have given more than half their populations a first shot while the UK had achieved 66 percent coverage. A sufficient number of Europeans have been vaccinated to allow crowds to once again mingle at football matches, although the lifting of restrictions has been controversial and may prove unwise.
Africa imports most of the pharmaceuticals it consumes – 70 to 80 percent according to the International Finance Corporation. A mere five African countries have facilities for vaccine production, only two of which are in sub-Saharan Africa (Senegal and South Africa). None of these facilities engage in the primary development of vaccines. Most simply package, label and distribute drugs invented in developed countries (and protected by patent), while a few, including South Africa’s Aspen Pharmacare and Biovac go to the next step in the value chain which is ‘fill and finish’. At this point, none even formulate (mix) the product let alone manufacture the critical drug substance or ‘active ingredient’ which has to imported from global sources.
It should be noted that even packaging and labelling is not a simple process. Cold and sterile chain requirements are daunting, to say nothing of logistical requirements. But existing manufacturing processes in Africa are a long way from making vaccines from scratch. Herein lies the challenge. Africa has great needs but needs alone do not change the project economics of vaccine making.
A key requirement for vaccine production is a predictable return on investment. Loans taken to finance expansions of manufacturing capacity need to be repaid and amortisation periods are typically several years. It would be a foolish firm which borrowed money to finance production of a product, like Covid-19 vaccines, for which there would be no demand within a year or two (as will hopefully be the case with Covid). That said, where production facilities exist, they can be repurposed. South Africa’s Aspen Pharmacare is using production facilities which once produced anaesthetics and anti-inflammatories to fill a 300 million dose (per year) order for Covid-19 vaccines from Johnson & Johnson.
The point is illustrated by the US government’s Operation Warp Speed (OWS), designed to get Covid-19 vaccinations injected into arms as rapidly as possible. OWS committed the US government to spending USD18 billion (about ZAR250 billion) to subsidise the rapid development of Covid-19 vaccines. In July 2020, the US government committed itself to large advance purchases of vaccines produced by Moderna and Johnson & Johnson (J&J). This allowed these companies to ramp up production facilities even before clinical trials had been completed and well before regulatory approvals (which were granted in December 2020).
A similar approach was taken in the UK, with 100 million doses being ordered by the government, from AstraZeneca as early as May 2020. At the same time the UK government committed £93 million (ZAR1.8 billion) to the rapid construction of a new manufacturing facility, to be completed within 12 months. This commitment to purchase the vaccine, made a full seven months before it was approved for use in the UK, gave the company the assurance it needed to set up its manufacturing line.
At risk advance spending is an option only available to countries with deep pockets. No African country could have afforded this sort of up-front commitment, especially given that there was no guarantee of success. The international COVAX facility, intended to supply vaccines to poorer countries, has made provision – via its Advance Market Commitment – to subsidise advanced purchases. But this commitment only came in mid-2021, far too late to incentivise vaccine makers. The alternative in Africa, the African Union’s African Vaccine Acquisition Trust, was even slower off the mark. By May 2021, only five of the AU’s 55 members had paid the 15 percent deposit required to secure vaccines.
The two main initiatives intended to galvanise African vaccine production are the application for a waiver of intellectual property rights for Covid-19 vaccines and the establishment, by the World Health Organisation, of a technology transfer hub in Cape Town. Both are well motivated but neither is likely to happen in time to make any impact on the present pandemic. The patent rights waiver is not only opposed by the European Union and UK governments (although the US has announced it is in favour) but is enmeshed in a complex and time consuming process and is highly unlikely to make any impact on the current pandemic.
It might well be asked whether major pharmaceutical companies would have proceeded with the development of their Covid-19 vaccines if they had expected to lose their patents soon after they had succeeded? The question is even more pointed in the case of the previously untried messenger RNA (mRNA) technology pioneered by Moderna and Pfizer. Prior to Covid, no mRNA vaccine had ever been approved although the technology had been identified as promising.
mRNA shows every sign of being an extraordinary breakthrough. One enthusiastic article describes its development as analogous to jumping from valves to microchips in a single generation. More sober assessments expect it to be used against influenza and other common viruses in future. But its development has everything to do with capable, high-tech, risk-taking, profit-driven companies: Moderna in the US and Pfizer’s technology partner BioNTech in Germany.
It has been suggested that mRNA technology offers Africa the opportunity to ‘leapfrog’ development in a manner similar to the development of mobile telephony. The technology is said to lend itself to ‘modular development’ and the thinking is that some modules could be located in Africa. But mRNA is so new, and so experimental, that this is simply speculation at this stage. Moderna’s chief executive argues that mRNA technology transfer to Africa is a ‘mid-term’ objective which suggests a five-year time horizon.
Africa’s movement towards vaccine self-sufficiency will be incremental. Its pioneers are likely to be private sector players like Aspen – which recently received a ZAR10 billion commercial loan from a consortium of international development finance institutions – and is firmly enmeshed in a market driven network dominated by big international pharmaceutical companies. It is they who call the shots. Aspen chief executive Stephen Saad, speaking on television news channel eNCA at the end of June, pointed out that the decision about how much of Aspen’s production of the J&J vaccine be supplied to African countries is not within his company’s ambit as it is merely a production sub-contractor.
A recent International Monetary Fund blog reminds us that vaccination is a global public good – leaving Africa behind means that all remain at risk. The continent’s current Covid-19 vaccine backlog requires urgent global attention. The immediate answer lies in a huge ramp-up in supply volumes from existing sources and ensuring access for all, including all in Africa.
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