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Only 3 percent of all doses of the Covid-19 vaccine will be sent in 2021 to Africa, home to a fifth of the world’s population, according to the World Health Organization. In the vast global vaccine disparity, Africa has been left the furthest behind as the pandemic rages, and the one with the least leverage in contract negotiations.
African leaders have vowed to make sure it never happens again. High-income countries and philanthropic groups have pledged to help fund efforts to make vaccine access more equitable. There have been numerous announcements of new partnerships and investments: plans to modernize some of our existing pharmaceutical manufacturing operations in Africa; plans for new construction; plans to send shipping containers from Europe with pop-up facilities to produce new mRNA vaccines; plans for an mRNA production incubator that will dispense open-source technology across the continent.
Now, some of the hype has died down, and there are some signs of real progress. But it is also a proof of how great the odds are.
There aren’t many shortcuts in the decades-long process of developing a biotechnology industry that can create routine vaccines for export, let alone create shots to protect against new pathogens.
The African Union has set a target of having 60 percent of all vaccines used on the continent produced in African countries by 2040 – up from 1 percent today – a plan that seems ambitious given the current production landscape.
The big problem, as always, is money. The multi-step vaccine manufacturing process requires strong biosecurity and quality control. The cost of implementing everything means that vaccines made in Africa will cost more than those from the Indian pharmaceutical industry, which is the main supplier of routine vaccines used in Africa.
Manufacturers such as the Serum Institute of India, the world’s largest producer of vaccines, have achieved large economies of scale and captured much of the market share held by European manufacturers. But the launch of the Covid vaccine made it clear that despite the cheap price of the Indian-made vaccine, African leaders cannot rely on it. In March 2021, when millions of doses of AstraZeneca’s serum-made vaccine were shipped to Africa, the Indian government banned exports and diverted the vaccine to its own population.
Africa’s Centers for Disease Control and Prevention says the continent’s current vaccine market is worth about $1.3 billion and is expected to grow to about $2.4 billion by 2030. But many working in global health say buyers will have to pay a “durability premium” . – higher prices for African-made vaccines, the production of which helps build African industries. There is less clarity about who will be willing to pay the higher price.
An obvious candidate is Gavi, an organization that uses funds donated by high-income countries and major philanthropies to buy 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, said that the organization is ready to sign advance purchase contracts with new vaccine manufacturers in developing countries, to guarantee business owners a stream of income that will offset investment in expansion.
“The traditional market economy that took us to a place where we have strong developing country manufacturers in Asia and Latin America will not take us to a place where we will have regional players on the African continent,” he said. . “Gavi is in a position to address market failures.”
If Gavi can provide that cushion, it is a project that experts say is most likely to help the continent achieve its goal of producing the majority of vaccines for Africans in Africa. Most require at least three years before they have a bottling and packing line.
In Senegal
The Institut Pasteur Dakar made a million doses of yellow fever vaccine a year before Covid, and business is booming. But now it has become a prime target for new investment and has almost completed a major expansion of its existing production plant. The goal is to increase production of yellow fever vaccine to 50 million doses per year. Another 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 bio-manufacturing platform from Univercells, a Belgian startup that aims to make vaccine ingredients faster 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 institution several times last year.
In South Africa
Aspen Pharmacare, one of the few serious pharmaceutical players in Africa before Covid, received an infusion of philanthropic funds of $ 30 million to build the production process of four main childhood vaccines, including shots for pneumonia and rotavirus.
In 2021, the World Health Organization set up an “mRNA production hub” in a small biotechnology company in Cape Town called Afrigen Biologics and Vaccines, with the aim of reverse-engineering the Moderna Covid vaccine and then sharing the knowledge of mRNA production in the global south. . Afrigen will put the Covid shot into clinical trials in early 2024. There is no longer a market for the Covid vaccine, but the hope is that the process of designing, testing and producing this product will increase the technological know-how to create others including the mRNA shot for tuberculosis, Afrigen’s 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 license and technology transfer deal to produce an oral cholera vaccine with the International Vaccine Institute, a South Korean non-profit organization.
In Rwanda
Six shipping containers arrived in the country in mid-March to form the “BioNTainer, – a pop-up mRNA vaccine manufacturing line packed in containers – donated by BioNTech, the manufacturer of mRNA technology in Pfizer’s Covid vaccine. The modular site is intended to form the core of the new vaccine production center .This will be done by Europeans in the first five years, according to BioNTech.
The main challenge here, Dr. Yadav notes that the site does not have a vaccine to make: There is no demand for a Covid vaccine, and BioNTech does not currently make any other products. A malaria or tuberculosis mRNA vaccine that could be useful for Rwanda and the region is likely more than a decade away. The new capacity in the country is for production only; in Rwanda, as in other African countries, there is no biotechnology industry that can carry out important research and development when responding to new pathogens, said Alain Alsalhani, a vaccine expert with access-to-medicine Doctors Without Borders. campaign.
And beyond
Two other companies – Biogeneric Pharma in Egypt, which will receive the transfer of mRNA technology from Afrigen, and SENSYO Pharmatech in Morocco – have received significant investments to expand production. And in Kenya, the government has the Kenyan BioVax Institute switch from producing animal vaccines to making them for humans. Has tapped Dr. Michael Lusiola, a Kenyan expatriate who is a senior executive with AstraZeneca in the UK, to come home and open.
Ms. Nguyen said having the ability to produce large quantities of vaccines would help keep Africa safe in the event of another pandemic. The continent could build that capacity when making routine vaccines for the African market, he said.
In most cases, this means starting with filling agreements for existing vaccines – making bulk vaccines made elsewhere into vials. Then the company can start making actual medicinal substances and, eventually, do research and develop vaccines, for known pathogens or for new ones.
Countries need stronger regulatory agencies so that vaccines can be quickly approved for export. They also need a better supply chain for everything that goes into vaccines. The African CDC hopes to make it regional, in some countries making glass vials and others making medicinal substances, as a way to ensure fair access in future pandemics.
Ms. Nguyen said she is encouraged by the number of African initiatives that are embracing new technologies that will allow them to “leap forward”. In the past, making vaccines required a large physical footprint, so producing large volumes paid off.
“Having a small unit that can get up and running and do five or 10 million doses and then switch to something else — I’m really changing the established market,” he said.
Many new initiatives rely heavily 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 unclear how long that enthusiasm will last. Martin Friede, who heads the vaccine research unit at the WHO, predicted that “the Covid pandemic will end this evening.” 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 question.”
Patrick Tippoo, chief scientist at Biovac in Cape Town and a key player in the African manufacturing network, said that’s what he and his colleagues heard at meetings. “There is a lot of good will from development finance institutions,” he said. but worries about how manufacturers can pay off debt. “That depends on the volume of the product and access to the market,” he continued. “So we’re kind of going around in circles.”
BioVac’s new cholera vaccine is a prime example of the promise of this new production capacity, and the obstacles it faces. There is a critical global shortage of the vaccine, and outbreaks are raging in several sub-Saharan countries. This will be the first time in decades that an African drug manufacturer will develop a strategic vaccine, go through the full chain of clinical development and become a manufacturer, regulatory authority and, BioVac hopes, prequalification by the WHO for global use. But it will be a multi-year process – and will require the construction of expensive new facilities.
“A number of things have progressed, and if half of them are successful, we will be doing well,” Mr Tippoo said. “It will come to us – the question is, Will it come to us?”
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