Of the total dose of Covid-19 vaccine distributed in 2021, only 3% went to Africa, home to one-fifth of the world’s population. According to the World Health OrganizationIn the apocalypse of global vaccine inequality, Africa has been the least marginalized and least influential in contract negotiations as the pandemic rages on.
African leaders have vowed to ensure that such a thing never happens again. High-income countries and charities have pledged to fund efforts to make access to vaccines more equitable. New partnerships and investment announcements continued. Plans to modernize some of its existing pharmaceutical manufacturing operations in Africa. Plans to build a new one. Plans to send shipping containers from Europe with pop-up facilities to produce new mRNA vaccines. Plans for mRNA production incubators to distribute open source technology across the continent.
Now, some of the hype has subsided and there are some signs of real progress. However, it also became clear how big the hurdles are.
In the decades-long process of developing a sophisticated biotech industry, there aren’t many shortcuts to developing shots that can make routine vaccines for export, much less protect against new pathogens.
The African Union has set a target for 60% of all vaccines used on the continent to be produced in African countries by 2040. Up from 1% today.
As usual, the big problem is money. The many-step process of manufacturing a vaccine requires a high degree of biosecurity and strict quality control. The cost of putting everything in place means that vaccines made in Africa will cost far more than vaccines from the Indian pharmaceutical industry, the main supplier of conventional vaccines used in Africa.
Manufacturers such as India’s Serum Institute, the world’s largest vaccine maker, have achieved huge economies of scale and have taken over much of the market share held by European manufacturers. has revealed that despite the low prices of vaccines made in India, African leaders cannot afford to rely on them. When shipped to India, the Indian government imposed an export ban and rerouted those vaccines to its own citizens.
The continent’s existing vaccine market is worth an estimated $1.3 billion and is expected to grow to about $2.4 billion by 2030, according to the African Center for Disease Control and Prevention. — African vaccines will become more expensive and their production will help build the African industry. It’s less clear who will be willing to pay that high price.
An obvious candidate is Gavi, an organization that uses funds donated by high-income countries and major charities to purchase routine and emergency vaccines for low- and middle-income countries. Gavi buys half of the vaccines currently in use in Africa.
Gavi’s chief program strategy officer, Aurélia Nguyen, said Gavi is ready to enter into pre-purchase agreements with new vaccine makers in developing countries, giving business owners a source of income to fund their expansion investments. He said he would guarantee it.
“Traditional market economics, which has led us to a place with strong developing country manufacturers in Asia and Latin America, is not going to take us to a place with regional players on the African continent. she said.. “Gavi is in a position to bridge the failure of the market.”
If Gavi can provide that cushion, these are the projects that experts say are most likely to help achieve the goal of producing the majority of vaccines for Africans in Africa in Africa. In most cases, it takes at least three years to get a bottling and packaging line up and running.
in Senegal
The Pasteur Institute in Dakar was producing one million doses of yellow fever vaccine a year before the Covid outbreak, but its business was sluggish. However, it has recently become a prime target for new investment and has nearly completed a major expansion of its existing production plant. It aims to increase production of yellow fever vaccine to 50 million doses per year. The second site will produce low-cost rubella and measles vaccines for the African market, with a production target of 300 million doses.
It will use a new biomanufacturing production platform from Univercells, a Belgian start-up that aims to manufacture vaccine components faster and in a smaller space.
“Progress in Dakar is faster than anywhere else in the world that I have seen,” said Prashant Yadav, a medical supply chain expert at the Global Development Center who has visited the institute several times over the past year. says.
in south africa
Aspen Pharmacare, one of Africa’s few serious pharma companies before Covid, has pledged $30 million in charitable funding to build a manufacturing process for four major pediatric vaccines, including pneumonia and rotavirus injections. was injected.
In 2021, the World Health Organization will establish an “mRNA production hub” at the small biotech company Afrigen Biologics and Vaccines in Cape Town. It aims to reverse engineer the Moderna Covid vaccine and share knowledge on mRNA production across the global South. Afrigen plans to put his Covid shots into clinical trials in early 2024. While there is no longer a market for a Covid vaccine, the process of designing, testing and manufacturing this product will build the technical know-how to manufacture other products, including Afrigen’s priority tuberculosis mRNA shots. is expected.
Afrigen’s production partner is the nearby BioVac Institute, which manufactures pediatric vaccines for South Africa. BioVac signed a deal to bottle his Covid vaccine for Pfizer (a process called fill-finish), and a new license and technology transfer with the International Vaccine Institute, a South Korean nonprofit, to manufacture an oral cholera vaccine. I have a contract.
in rwanda
Six shipping containers will be shipped across the country in mid-March to form the first “BioNTainer,” a container-packaged pop-up mRNA vaccine production line donated by BioNTech, maker of Pfizer’s Covid vaccine mRNA technology. Arrived at The modular site is intended to form the core of a new vaccine manufacturing center. According to BioNTech, his first five years will be staffed by Europeans.
Dr. Yadav noted that the key challenge here is that the site does not have a vaccine to create. There is no demand for a Covid vaccine and BioNTech is not currently manufacturing any other products.An mRNA vaccine for malaria or tuberculosis that could help Rwanda and the region is probably a decade away. The new capacity in the country is dedicated to production. Rwanda, like most other African countries, does not have a biotechnology industry capable of the kind of research and development that is essential in responding to new pathogens. Expert Alan Alsarhani said. motion.
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Two companies, Biogeneric Pharma in Egypt, which will receive mRNA technology transfer from Afrigen, and SENSYO Pharmatech in Morocco, have received significant investments to scale up production. And in Kenya, the government is trying to get the Kenya Biovacs Institute to switch from producing animal vaccines to producing vaccines for humans. An expatriate Kenyan, Dr. Michael Luciola, who was a senior executive at AstraZeneca in the UK, asked to return and run it.
Nguyen said the ability to manufacture large quantities of the vaccine would help bring safety to Africa in the event of another pandemic. She said she can build on that ability.
In most cases, that means starting with a full-fledged contract for an existing vaccine. That is, put a bulk vaccine manufactured somewhere else in a vial. The company then begins manufacturing the actual drug substance and eventually conducts research to develop vaccines for known or new pathogens.
Countries need stronger regulatory bodies so vaccines can be approved for export expeditiously. It will also require improvements in all supply chains used for vaccines. Africa CDC wants to create a regional one with some countries manufacturing glass vials and others manufacturing active pharmaceutical ingredients as a way to ensure equitable access in future pandemics .
Nguyen said he was encouraged by the number of initiatives in Africa that are adopting new technologies that allow them to make a “leap.” In the past, manufacturing vaccines required a huge physical footprint, so huge volumes had to be produced to cover the cost.
“I think having a small unit that can run and do 5 million to 10 million doses and then switch to something else really changes the established market,” she said.
Many of the new initiatives rely heavily on philanthropic funding, much of it from the Bill & Melinda Gates Foundation and the Multinational Coalition for Epidemic Response Innovations, including low-cost bilateral loans. . Not sure how long that enthusiasm will last. “By this afternoon, Covid guilt will be gone,” said Martin Friede, who heads the WHO’s vaccine research arm. He added, “I don’t think South Africa would agree to buy vaccines from Nigeria at a higher price than vaccines from India or Europe. That’s a tough request.”
Patrick Tippoo, chief scientist at Biovac in Cape Town and a key figure in the African Network of Manufacturers, said it was similar to what he and his colleagues had heard at the conference. “There is a lot of goodwill coming from development finance institutions,” he said. However, concerns about how the manufacturer can repay the loan. “It depends on product volume and market access,” he continued. “So we’re going round and round a little bit.”
BioVac’s new cholera vaccine is a prime example of the promise of this new manufacturing capacity and the obstacles it faces. The vaccine is in acute global shortage, with outbreaks raging in several sub-Saharan countries. It is the first time in decades that an African pharmaceutical company has developed a strategic vaccine, undergoing a full chain of clinical development, manufacturing, regulatory approval and even, as his BioVac hopes, a global approval by the WHO. Go through the process leading up to pre-qualification for use. But that would be a multi-year process that would require the construction of new facilities that would be costly.
“A lot of things are progressing, and if half of them succeed, it will work,” Tipu said. “It will bring us closer — the question is will it bring us close enough.”
