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The continent’s leaders promised that if there were any other pandemics, they would not be shut out of the vaccine market.
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By Stéphanie Nolen
According to the World Health Organization, only 3% of all Covid-19 vaccine doses delivered in 2021 went to Africa, which is home to a fifth of the world’s population. The pandemic broke out and had the least influence to negotiate contracts.
African leaders are committed to making sure this never happens again. High-income countries and philanthropic teams have pledged to help fund efforts to make vaccines more equitable. There has been a flurry of announcements of new partnerships and investments: plans to modernize Africa’s handful of existing pharmaceutical production operations; plans to build new ones; plans to ship shipping boxes from Europe with emerging services to produce the new mRNA vaccines; Plans for an mRNA production incubator that would distribute the open source generation across the continent.
Now, some of the hype has subsided and there are symptoms of genuine progress. But it has also become clear how vital obstacles are.
There are many shortcuts in the decades-long process of creating a complex biotech industry that can manufacture a regime vaccine for export, let alone expand a vaccine to protect against a new pathogen.
The African Union has set a target of 60% of all vaccines used on the continent being produced in African countries by 2040, up from 1% today, a plan that is incredibly ambitious given the existing production landscape.
The big problem, as always, is money. The multi-step vaccine production procedure demands maximum biosecurity and intense quality control. The down payment means that vaccines manufactured in Africa will cost much more than those from the Indian pharmaceutical industry, which is the main supplier of regimen vaccines used in Africa.
Manufacturers such as the Serum Institute of India, the world’s largest vaccine manufacturer, have achieved massive economies of scale and seized much of the market share held by European producers. But the rollout of the Covid vaccine has made it clear that, despite the low value of Indian-made vaccines, African leaders cannot rely on them. In March 2021, when millions of doses of the serum-based AstraZeneca vaccine were destined for Africa, the Indian government imposed an export ban and diverted those vaccines back to its own population.
The African Centers for Disease Control and Prevention says the continent’s existing vaccine market is worth around $1. 3 billion and is expected to succeed at around $2. 4 billion through 2030. But many who paint on global fitness say buyers will have to pay a “resilience premium” — a premium value for vaccines made in Africa, whose production is helping the African industry. There is much less clarity about who will be willing to pay this higher value.
The apparent candidate is Gavi, the organization that uses donated budget through high-income countries and primary philanthropy to procure regime and emergency vaccines for low- and middle-income countries. Gavi buys part of the vaccines used in Africa today.
Aurélia Nguyen, Gavi’s head of program strategy, says the organization is in a position to signal advance purchase agreements with new vaccine brands in emerging countries, so that certain business owners have a profit stream that covers expansion investments.
“The classic market position economy that has taken us to a position where we have strong brands from emerging countries in Asia and Latin America will lead us to a position where we are going to have regional players on the African continent,” he said. . . ” Gavi is in a position to close the market position failure. “
If Gavi is going to provide this cushion, it’s the projects that experts say are as much as possible to help the continent achieve the goal of generating the most vaccines for Africans in Africa. Most will need at least 3 years before they even have a bottling. and packaging line in operation.
The Institut Pasteur in Dakar manufactured one million doses a year of yellow fever vaccine before Covid and its activity was at half-mast. But recently it has been a prime target for new investments and has almost finished a gigantic expansion of its existing production plant. It aims to increase its production of yellow fever vaccines to 50 million doses consistent with the year. A momentary site will produce a cheap rubella and measles vaccine for the African market, with a production target of three hundred million doses.
It will use a new biomanufacturing production platform from Univercells, a Belgian start-up that aims to manufacture vaccine ingredients and in a smaller space.
“The progress in Dakar is the fastest I’ve noticed in the world,” said Prashant Yadav, a medical chain expert at the Center for Global Development who has visited the institute several times over the past year.
Aspen Pharmacare, one of the few serious pharmaceutical players in Africa before Covid, won a $30 million injection into a philanthropic budget to set up a production process for four of the vaccines for the first years of training, pneumonia and rotavirus vaccines.
In 2021, the World Health Organization established an “mRNA production hub” at a small Cape Town biotech company called Afrigen Biologics and Vaccines, with the aim of opposing the Moderna Covid vaccine and then sharing knowledge about mRNA production in the global south. Afrigen will put its Covid vaccine into clinical trials in early 2024. There is no longer a market for Covid vaccines, but the hope is that the procedure of designing and generating this product will gather technological know-how to make others, adding an mRNA Draw for TB, a precedent for Afrigen.
Afrigen’s production partner is the neighbouring BioVac Institute, which manufactures vaccines for the formative years for South Africa. BioVac has signed an agreement to bottle Pfizer’s Covid vaccine (a procedure called filling and finishing), and has a new license and generation transfer agreement to produce an oral vaccine. cholera vaccine with the International Vaccine Institute, a foreign organization supported by the United Nations in South Korea.
Six shipping boxes arrived in the country in mid-March to shape the first “BioNTainer, an emerging mRNA vaccine production line packaged in a container, introduced through BioNTech, the manufacturer of the mRNA generation in Pfizer’s Covid vaccine. The modular is intended to form the core of a new vaccine production center. It will be made up of Europeans for the first five years, according to BioNTech.
A key challenge here is that the site doesn’t have a vaccine to manufacture: there’s no demand for the Covid vaccine, and BioNTech doesn’t recently manufacture any other products. An mRNA vaccine against malaria or tuberculosis that could be useful for Rwanda and the region is probably at most a decade away. The country’s new capacity is for production only; In Rwanda, as in many other African countries, there is no biotech industry capable of conducting the kind of studies and breakthroughs needed to respond to a new pathogen, said Alain Alsalhani, a vaccine expert for medicines at Doctors Without Borders. . campaign.
Two other corporations, Biogeneric Pharma in Egypt, which will take advantage of an Afrigen mRNA generation movement, and SENSYO Pharmatech in Morocco, have gained significant investments to expand their production. And in Kenya, the government is asking Kenya’s BioVax Institute to move from generating vaccines for animals to producing vaccines for humans. He called Dr. Michael Lusiola, a Kenyan expat who is a senior executive at AstraZeneca in the UK, to approve and lead it.
Nguyen said the ability to manufacture a large number of vaccines would help keep Africa safe in the event of a new pandemic. The continent could have this capacity while producing vaccines for the African market, he said.
In most cases, this will mean starting with filling and finalization agreements for existing vaccines, putting a manufactured bulk vaccine in vials. Corporations can then start producing the drug itself and eventually conduct studies and expand the vaccines, either for acquaintances. pathogens or for new pathogens.
Countries will want stronger regulatory bodies so that their vaccines can be temporarily approved for export. They will also want larger chains of origin for everything that goes into vaccines. Africa CCC hopes to create regional bodies, in which some countries manufacture glass vials and other pharmaceutical substances, to ensure fairness in a pandemic in the long term.
Nguyen said he encouraged through the number of African projects that were adopting new technologies that would allow them to “jump over. “In the past, vaccine production required a huge physical footprint, which meant generating massive volumes to pay for it.
“Having a small unit that can be operational and do five or 10 million doses, and then move on, I think it fits the established market,” he said.
Many of the new projects rely heavily on philanthropic funding, largely from the Bill Foundation.
Patrick Tippoo, Biovac’s lead scientist in Cape Town and a key player in Africa’s brand network, said it sounded like what he and his colleagues heard at meetings. “There is a lot of goodwill in the progressive financial institutions component,” he said. He said, but worries about how brands can repay the loans. “It’s based on product volumes and market access,” he continued. “So we’re going around a little bit. “
BioVac’s new cholera vaccine is a perfect example of the promise of this new production capacity and the obstacles it faces. There is a critical global shortage of this vaccine and outbreaks are wreaking havoc in several sub-Saharan countries. This will be the first time in decades that an African drugmaker has developed a strategic vaccine, taking it through the entire chain of clinical progression and through production, regulatory approval and, BioVac, WHO prequalification for global use. But it will be a multi-year procedure and will require the structure of new and beloved facilities.
“Several things have advanced, and if some of them succeed, we will do well,” M. Tippoo. ” It will bring us closer, that is, will it bring us close enough?”
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