At a time when Africa is sorely lacking in Covid-19 vaccines, advocacy for local production is gaining momentum. While some countries already have concrete prospects with major pharmaceutical companies – mainly Johnson & Johnson, Sputnik V and Sinovac – production schedules and volumes, as well as supply and distribution arrangements, still remain very unclear. Furthermore, many negotiations are still underway on the subject, both between Africans and with Western, Russian and Chinese groups as well as international institutions.
In the wake of the pandemic, African policymakers have realised the need to develop their pharmaceutical industry. Hopes were fuelled by a high-level virtual conference, which was organised on 12 April by the African Union’s African Centre for Disease Control and Prevention (Africa CDC).
Its director, John Nkengasong from Cameroon, would like to see the continent producing more than half of the vaccines it consumes within 20 years, up from 1% today. At the same time, the African vaccine market is expected to grow significantly, from $1.3bn a year today to between $2.3bn and $5.4bn by 2030, according to US strategy firm McKinsey.
Five regional production hubs
As for the anti-coronavirus vaccine, the continent has so far received less than 2% of the doses administered worldwide.
Africa would need 1.5 billion doses to vaccinate 60% of its population and thus reach the minimum threshold for herd immunity, according to estimates. It is expected that the Covax programme will eventually provide 20% of the requirement. More than two billion doses produced outside the continent have been negotiated, but only a few million have been received.
These vaccines, which have been supplied mainly by Pfizer and AstraZeneca (via their various platforms, including the Serum Institute of India), are slow to be distributed. The fact that Indian exports have been suspended does not help the situation.
The African Union (AU) has also set up its own initiative called Avatt (African Vaccine Acquisition Task Team), and has already announced that it has negotiated 670 million doses, thanks to support from Afreximbank and the World Bank.
The CDC envisages the creation of five or six regional clusters of expertise, based in nations that have the capacity to produce these vaccines. So far, countries in the Maghreb and South Africa are leading the way, while in West Africa, Nigeria and Senegal stand out and Ghana is trying to get in on the action, as is Rwanda in East Africa.
But so far, bilateral negotiations to produce these vaccines have been the mainstay of multilateral coordination. This makes sense when countries have been investing in the sector for years and are trying to support themselves first.
In fact, some already produce other types of human or veterinary vaccines. There are also about 80 sterile injectable factories on the continent, according to William Ampofo, chairman of the African Vaccine Manufacturing Initiative (Avmi). These are all structures that can be adapted relatively quickly, according to the specialists interviewed. But nothing will happen without technology transfer.
“It all depends on what type of vaccine we’re talking about. Messenger RNA (Moderna, Pfizer-BioNtech and CureVac) requires infrastructure and skills that the continent does not have,” says Nathalie Coutinet, a researcher in health economics at the Université Sorbonne-Paris-Nord.
None of the potential regional hubs is yet able to produce these vaccines from start to finish. At best, some can process its concentrated form and dispense it into vials in an aseptic manner (fill and finish), in the hope of eventually developing their biotechnologies to prepare for other epidemics. But a veil of uncertainty surrounds the negotiations with the big laboratories.
“All of this is being done without transparency, which is not acceptable at such a critical time,” says Nathalie Ernoult, director of advocacy for access to essential medicines at Doctors Without Borders.
When contacted, all the major laboratories gave very vague comments. Merck said it was not in a position to answer our questions “at this time.” Is this a sign that negotiations are taking place or that the African production strategy is not on the agenda? Pfizer has only stated that it is willing to add more contract manufacturers to its production chain.
In North Africa, Egypt boasts production agreements with China’s Sinovac and Russia’s Sputnik V. Algeria has also announced that it will be developing Sputnik V. According to a pharmacist close to the case, the Saidal group, which did not wish to answer our questions, was assisted in transforming a unit initially intended for antiretrovirals.
As a thank you, Russia has been given access to the Algerian drug market and to national health data. In addition to upgrading its units and producing for its domestic market, Algiers can now negotiate the sale of Sputnik V and other pharmaceutical products to the sub-Saharan region.
“Contracts are hard-fought,” says Bartholomew Dicky Akanmori, WHO’s adviser for vaccine research and regulation in Africa. “The laboratories that carry out these technology transfers may ask for access to markets to sell other products, propose to African partners that they also produce generic medicines or ask for tax exemptions.”
Some have reportedly negotiated clinical trial packages in exchange for manufacturing agreements. For example, Johnson & Johnson in South Africa with the laboratory Aspen, the leading African pharmaceutical group ($2.7bn in turnover in 2020) that is managed from Durban. The latter confirms that it started production in its Port Elizabeth factory when a preliminary agreement was signed in November 2020. Aspen estimates that it produces 300 million doses per year.
Johnson & Johnson has promised to supply the AU with 220 million doses of the one-shot vaccine starting this month. These doses, which will be sold to African countries at $10 each (€8.50), will be distributed – according to quotas – to the pan-African organisation’s member countries.
The pharmaceutical company also says that it is looking for other production sites. The US company ImmunityBio is also testing its vaccine in South Africa and is discussing technology transfer with Biovac, the country’s public institute, while exploring the prospects of local production for other treatments.
Others are still trying to position themselves. In Tunisia, the minister of health announced that a preliminary agreement to manufacture the AstraZeneca vaccine had been made. However, the laboratory’s press office denied this, saying that “we have authorised technology transfers in 15 countries, but this does not include agreements with Tunisia or Morocco.” Meriem Khrouf, the ministry’s director of pharmaceuticals and medicines, says that “discussions with various partners are underway.”
In Morocco, Sothema is hoping for a technology transfer from the Chinese company Sinopharm, which has involved it in its studies and, in return, has asked about its industrial possibilities. “Sothema was the only laboratory that we visited that demonstrated its ability to produce vaccines for Africa to the WHO following the H1N1 pandemic,” says its CEO, Lamia Tazi, promoting its pre-filled sterile syringes.
At the Institut Pasteur in Dakar, which is the only producer on the continent that has been pre-qualified by the WHO to manufacture a vaccine (against yellow fever), “the transfer of skills is under discussion,” says director Amadou Sall.
Towards an African vaccine?
And why not produce an African vaccine? Egypt says that it is developing its Covi-Vax with the National Research Centre. The African Centre of Excellence for Genomics of Infectious Diseases in Nigeria is fine-tuning its own, which would be stored at room temperature. “Preclinical animal trials show that it offers very good protection against variants,” says director Christian Happi, who is waiting to start clinical trials. But he needs $189m to continue his research. Again, discussions are reportedly underway.
Elsewhere, the authorities and local manufacturers are working hard to catch up. Many African pharmaceutical groups have not progressed beyond packaging bulk drugs for the local market. For its part, Ghana’s presidency has set up a production committee. Kenya, which produces vaccines for livestock, is looking to increase its genome sequencing capacity but lacks experience in aseptic filling.
Tazi, in her capacity as secretary-general of the Moroccan Federation of the Pharmaceutical Industry (Fmip), calls for investment in the extension of existing fill and finish units. She specifies that a laboratory “cannot consider these investments alone if it does not have pre-orders.”
She adds: “Between $150m and $250m is needed for a full-scale manufacturing facility in Africa,” says Patrick Tippoo, director of Avmi. Stakeholders will also need to create a market by securing demand. Akanmori envisages that in the long term “countries could move to other more lucrative pharmaceutical production – vaccine or otherwise – from these platforms.” However, not all vaccines guarantee a return on investment – a dose of BCG, for example, sells for only $0.1.
Another problem is the dual dependence on pharmaceutical licences and the supply of imported components. According to a report by the Rabat-based Policy Center for the New South, the continent should do more to explore the potential of its own pharmaceutical raw materials, much of which has yet to be scientifically assessed.
Another obstacle to local production is the omnipresence of free vaccine suppliers such as the Gavi alliance, which often buys from ultra-competitive Indian and Chinese suppliers. “40 out of 54 African countries depend on Gavi for their vaccines,” says Tippoo, “which makes it difficult to envisage investments in the next 10 years.”
There are calls to harmonise the continent’s regulations. The African Medicines Agency, which is supposed to spearhead this issue, is struggling to see the light of day. In southern Africa, where efforts have been made to unify pharmaceutical regulations, South Africa is already supplying its neighbours.
The African Continental Free Trade Area (AfCFTA) could create a favourable environment and prospects for economies of scale. Laboratories and companies in different states could share research, development and production through joint ventures. “At present, it is cheaper to import from outside the continent than from your neighbours,” says Akanmori.
Variants could also reshuffle the deck. While AstraZeneca does not seem to provide sufficient protection against the South African strain, ImmunityBio is already exploring the potential of T-cells to cope with these mutations. What if delay becomes an asset? New generations of vaccines offer opportunities. African laboratories will manufacture later than elsewhere, but may well create products that are better adapted to their health environment.
A shot at what price?
The Johnson & Johnson vaccine, produced in South Africa with support from the AU, will be sold for $10 to African countries. The Pfizer-BioNTech vaccine (not produced on the continent) will be sold at cost (less than $10) in low-income countries, at around $10 in middle-income states, and for $18 to $23 in Europe, the US and Japan.
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