Just 3 percent of all Covid-19 vaccine doses delivered in 2021 went to Africa, home to a fifth of the world’s population, . In the vast debacle of global vaccine inequity, it was Africa that was left furthest behind as the pandemic raged, and that had the least leverage to negotiate contracts. African leaders vowed to make sure that never happened again.
High-income nations and philanthropic groups promised to help fund the effort to make vaccine access more equitable. There was a flurry of announcements of new partnerships and investments: plans to modernize the handful of existing pharmaceutical manufacturing operations in Africa; plans to build new ones; plans to send shipping containers from Europe with pop-up facilities to produce the new mRNA vaccines; plans for an mRNA production incubator that would dispense open-source technology around the continent. Now, some of the hype has subsided, and there are some signs of real progress.
But it’s also become evident just how big the hurdles are. There aren’t many shortcuts in the decades-long process of developing a sophisticated biotechnology industry that can make a routine vaccine for export, let alone develop a shot to protect against a new pathogen. The African Union has set a goal of having 60 percent of all vaccines used on the continent produced in African nations by 2040 — up from 1 percent now — an plan that looks wildly ambitious given the current production landscape.
The big issue, as always, is money. The many-step process of making vaccines needs high biosecurity and intense quality control. The expense of putting it all in place means that vaccines made in Africa are going to cost significantly more than those from the Indian pharmaceutical industry, which is the major supplier of routine vaccines used in Africa.
Manufacturers such as the Serum Institute of India, the world’s largest vaccine maker, have achieved huge economies of scale and have taken over much of the market share that was held by European producers. But the Covid vaccine rollout made clear that despite the low price of Indian-made vaccines, African leaders cannot afford to rely on them. In March 2021, when millions of Serum-made doses of the AstraZeneca vaccine were bound for Africa, the Indian government imposed an export ban and rerouted those vaccines to its own population.
The Africa Centers for Disease Control and Prevention says 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.
But many who work in global health say buyers will have to pay a “resilience premium” — a higher price for African-made vaccines, the production of which helps build up the African industry. There is a lot less clarity about who is going to be willing to pay that higher price. The obvious candidate is Gavi, the organization that uses funds donated by high-income countries and major philanthropies to purchase routine and emergency vaccines for low- and middle-income countries.
Gavi buys half the vaccines used in Africa today. Aurélia Nguyen, Gavi’s chief program strategy officer, says the organization is ready to sign advance purchase contracts with new vaccine makers in developing countries, to assure business owners of an income stream that will defray investments in expansion. “The traditional market economics that got us to a place where we have strong developing-country manufacturers in Asia and Latin America are not going to get us to a place where we’re going to have regional players in the African continent,” she said.
“Gavi is in a position to bridge the market failure. ” If Gavi is able to provide that cushion, these are the projects that experts say are most likely to help the continent reach the goal of producing a majority of vaccines for Africans in Africa. Most will need at least three years before they have even a bottling-and-packaging line running.
The Pasteur Institute of Dakar was making a million doses a year of yellow fever vaccine before Covid, and its business was flagging. But it has recently been a major target for new investment and has nearly completed a large expansion of its existing production plant. It is aiming to increase its production of yellow fever vaccine to 50 million doses a year.
A second site will produce a low-cost rubella and measles vaccine for the African market, with a production target of 300 million doses. It will use a new bio-manufacturing production platform from Univercells, a Belgian start-up that aims to make vaccine ingredients more quickly and in a smaller space. “The progress in Dakar is the fastest I’ve seen anywhere in the world,” said Prashant Yadav, a medical supply chain expert at the Center for Global Development who visited the institute several times over the past year.
Aspen Pharmacare, one of the few serious pharmaceutical players in Africa before Covid, received an infusion of $30 million in philanthropic funds to build up a production process for four of the main childhood vaccines, including shots for pneumonia and rotavirus. In 2021, the World Health Organization set up an “mRNA production hub” at a small biotechnology company in Cape Town called Afrigen Biologics and Vaccines, with the goal of reverse-engineering the Moderna Covid vaccine and then sharing mRNA production knowledge across the global south. Afrigen will put its Covid shot into clinical trials in early 2024.
There is no longer a market for Covid vaccines, but the hope is that the process of designing, testing and producing this product will build up technological know-how to make others including an mRNA shot for tuberculosis, an Afrigen priority. Afrigen’s production partner is the nearby BioVac Institute, which makes childhood vaccines for South Africa. BioVac signed a deal to bottle Pfizer’s Covid vaccine (a process called fill-finish), and has a new licensing and technology transfer deal to produce an oral cholera vaccine with the International Vaccine Institute, a United Nations-backed international organization based in South Korea.
Six shipping containers arrived in the country in mid-March to form the first “BioNTainer — a pop-up mRNA vaccine manufacturing line packaged in the containers — donated by BioNTech, the maker of the mRNA technology in Pfizer’s Covid vaccine. The modular site is intended to form the core of a new vaccine manufacturing center. It will be staffed by Europeans for the first five years, according to BioNTech.
A key challenge here is that the site has no vaccine to make: There is no demand for the Covid vaccine, and BioNTech does not currently make any other product. A malaria or tuberculosis mRNA vaccine that could be useful for Rwanda and the region is most likely a decade away. The new capacity in the country is only for production; in Rwanda, as in most other African countries, there is no biotech industry capable of the kind of research and development that is essential when responding to a new pathogen, said Alain Alsalhani, a vaccines expert with Doctors Without Borders’ access-to-medicines campaign.
Two more companies — Biogeneric Pharma in Egypt, which will receive an mRNA technology transfer from Afrigen, and SENSYO Pharmatech in Morocco — have received significant investment to expand their production. And in Kenya, the government is having the Kenya BioVax Institute switch from producing animal vaccines to making human ones. It has tapped Dr.
Michael Lusiola, an expatriate Kenyan who was a senior executive with AstraZeneca in the United Kingdom, to come home and run it. Ms. Nguyen said that having the ability to manufacture large numbers of vaccines would help to give Africa security in the event of another pandemic.
The continent could build that capacity while making routine vaccines for the African market, she said. In most cases, that will mean starting with fill-finish agreements for existing vaccines — putting a bulk vaccine made somewhere else into vials. Then companies can begin manufacturing the actual drug substance and, eventually, conduct the research and develop the vaccines, either for known pathogens or for new ones.
Countries will need stronger regulatory agencies so their vaccines can be quickly approved for export. They will also need better supply chains of everything that goes into vaccines. The Africa C.
D. C. hopes to create regional ones, in which some countries make glass vials and others make drug substances, as a way to ensure equitable access in a future pandemic.
Ms. Nguyen said she was encouraged by the number of African initiatives that were embracing new technologies that would allow them to “leapfrog. ” In the past, making vaccines required a huge physical footprint, so that meant producing huge volumes to pay for it.
“Having a small unit that can get up and running and do five or 10 million doses and then switch to something else — I think that really changes the established marketplace,” she said. Many of the new initiatives are heavily dependent on philanthropic funding, much of it from the Bill & Melinda Gates Foundation and the multilateral Coalition for Epidemic Preparedness Innovations, as well as low-cost bilateral loans. It’s not clear how long that enthusiasm will last.
Martin Friede, who leads the vaccine research unit at the W. H. O.
, predicted “the Covid guilt will be over by this afternoon. ” He added, “I just don’t see South Africa agreeing to buy vaccines from Nigeria at a higher price than vaccines from India or Europe — that’s a tough ask. ” Patrick Tippoo, the head scientist at Biovac in Cape Town and a key player in the African network of manufacturers, said that was similar to what he and his colleagues were hearing in meetings.
“There’s a lot of good will from development financing institutions,” he said, but concern about how manufacturers can repay loans. “That’s reliant on product volumes and access to markets,” he continued. “So we kind of go around in circles 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. There is a , and outbreaks are raging in several sub-Saharan countries. This will be the first time in decades that an African drugmaker will be developing a strategic vaccine, taking it through the full chain of clinical development and into manufacturing, regulatory authorization and, BioVac hopes, prequalification by the W.
H. O. for global use.
But it will be a many-year process — and will require construction of costly new facilities. “A number of things have advanced, and if half of them succeed we will be doing well,” Mr. Tippoo said.
“It will take us closer — the question is, Will it take us close enough?”.
From: nytimes
URL: https://www.nytimes.com/2023/04/25/health/africa-vaccine-independence.html
