Cape Town, South Africa: In early December 2021, infections of a new coronavirus variant, Omicron, were tearing apart South Africa, where another 90,000 people had already died from the pandemic.
COVID-19 cases had increased by 255% in one week among a population of which 24% were fully vaccinated and the country had reached a peak of nearly 27,000 new infections per day.
On a windy Monday morning, Dr. Caryn Fenner drove half an hour from his private network to his workplace, located in an open-air commercial suburb of Cape Town. -Deck warehouses, each the length of a football field, housing coffee makers, transport corporations and metal mills.
Fenner, who is the CEO of Afrigen Biologics
When, on November 26, 2021, the World Health Organization (WHO) named Omicron as a concerning variant, within hours, foreign governments imposed bans in part of a dozen African countries, including South Africa.
The economic impact was immediate. Shares on the Johannesburg Stock Exchange fell about 2% at midday, and the rand was trading at its lowest level in more than a year.
South Africa itself had alerted the WHO to the variant after scientists in Botswana detected it among travelers from Europe. South Africa’s Ministry of Foreign Affairs criticized the bans. “Scientific excellence should be applauded, not punished,” he said.
The travel ban has had an effect on Afrigen. The equipment and chemicals needed for the vaccine’s progression were stranded overseas. The plane tickets of foreign scientists who arrived here to cooperate were canceled, as were those of the personnel who were to travel. Go through education abroad. Ground flights have also delayed the exchange of laboratory samples from Omicron to speed up studies on the new strain. These progressions almost completely disrupted global clinical collaboration and delayed Afrigen’s studies for several months.
“It was a big deal,” Fenner says with apparent understatement as he sits at the table at his small, white-walled table.
Take a sip of water and look gloomy out the window. Send emails about progress reports and presentations. A handwritten note on his table reminds him of Africa’s vaccine goals, adding that Senegal aims to “fill and finish” three hundred million. dose per year. Week after week, Afrigen worked 24 hours a day to oppose the Modern engineer’s formula. For Fenner, that meant sacrificing time with her husband and two young children.
He spent nights in the workplace navigating the grim realities of logistics and procurement constraints in Africa. Then, on a Wednesday night in January 2022, Fenner and his team made a breakthrough: They had controlled microliter production of the vaccine — the first copy was produced. almost entirely without the assistance and approval of the developer.
“If we had had the active participation of Moderna, I don’t know if it would have been faster, but it would have been easier,” says Petro Terblanche, Afrigen’s lead executive, with a steely expression and black-rimmed glasses.
For Terblanche, the best time to bring mRNA vaccines to Africa will be to adapt them to the African context. mRNA molecules are enveloped in a lipid nanoparticle due to their fragility and require excessive storage without blood. In collaboration with the University of the Witwatersrand in Johannesburg, known as Wits, the researchers plan to expand new formulas for the vaccines, which do not require ultra-low freezing, which is a challenge for some African countries suffering from normal blackouts or rural communities without electricity.
“To me, this is probably the ultimate innovation this center and the Wits scientists can do,” he adds ostensibly. For now, the quickest hurdle is generating more reproductive vaccines, so that human trials can begin in May 2023. Moderna told Al Jazeera that the company is already running a next-generation edition of its vaccine that would be “refrigerator stable” for upcoming countries.
The vaccines were developed in the year following the outbreak of the COVID pandemic, but due to a supply war with wealthier Western countries, much of Africa is the last to receive the doses. Afrigen is the focus of a pilot assignment created by WHO for percentage of knowledge in the production of mRNA vaccines with “shelves”, or brands, from more than 20 countries in Eastern Europe, Latin America and Africa, as well as Egypt, Kenya, Nigeria, Senegal and Tunisia. The move came after brands Moderna, Pfizer and its partner BioNTech refused a percentage of vaccine revenue. In South Africa, Afrigen will manufacture the mRNA and the Biovac Institute will manufacture the vaccines.
As demand for COVID-19 vaccines wanes, fitness experts say the stakes are higher. African countries now import 99% of their vaccines and 70% of all medicines used, but the African Union has set a target of up to 60% of the vaccination regimen to be produced on the continent until 2040.
The infrastructure to achieve this purpose is limited. Only 10 African brands produce vaccines against any disease. One challenge Afrigen had to overcome was that since there is no giant pharmaceutical industry in Africa, local researchers had little interest in processing drugs according to advertising criteria and complying with foreign regulatory requirements.
“The scientists we can get are in universities,” Terblanche says. “But we want to exercise them to work in a matrix of vaccine facilities . . . and not in educational research. “
Take Frances Lees. La young scientist joined Afrigen in January 2020, just as the pandemic was beginning. Lees earned a master’s degree in mobile biology and worked on veterinary vaccine projects before temporarily becoming involved in mRNA progression as one of the few researchers with expertise in molecules. .
After graduating, many scientists on the mainland are hired for natural clinical research. Producing vaccine prescriptions on a large scale is a monumental task on a continent with few pharmaceutical companies. For Lees, this required “a huge change of mentality. “
Speaking in Afrigen’s colorful kitchen, which serves as a rest area for staff, Lees says copying a manufacturer’s vaccine without their help means no one can know why a specific error occurs.
“Sometimes it goes wrong, and you don’t know why and you have to repeat your experience, then there are a lot of processes that take time,” he says. “And time is not our friend right now. “
Lees believes that a breakthrough would end the misconception that such studies and advances are being done in Africa.
“Synthesizing mRNA is very difficult; He’s trying to make sure we have a lot of them. . . with a high enough quality for a vaccine,” he says. “We’re going to skimp on raw fabrics or cut costs. “
Dr. Hapiloe Maranyane is new to Afrigen, having started in April as a principal investigator. She’s alone in the lab room, searching with goggles, and holding a single-channel dropper pipette in one hand while dispensing chemicals inside a bioprotection cabinet. . He opens his magazine on a blank page and starts taking notes.
In the production of advertising vaccines, “it’s not just science that matters,” he says. Your science and quality assurance you want to be stratified and quality control.
When the pandemic hit, Maranyane spent six months unemployed despite earning two doctorates in cancer studies and infectious disease education. When he met with Fenner, Afrigen’s CEO expressed interest in his fundamental knowledge of cellular RNA and told him that Afrigen was looking for molecular biologists and medical biochemists.
“There was really no work,” he says, recalling former colleagues, experts in the fields of chemistry, plant biology and mobile, who had left science to sell handbags or moved to find work. “And those would have been brilliant scientists, the most productive in the class,” he says, hitting a remarkably solemn note compared to his own old laugh.
“It’s traumatic to go through the pandemic and feel helpless, not only nationally but clinically,” she says.
Maranyane describes a clinical industry that does not need a corps of highly skilled painters in Africa, but graduates who can repeat fundamental responsibilities, while most professional paintings are still the work of scientists founded at a company’s headquarters in Europe or the United States.
“What’s unique to Afrigen,” he says, is that “it takes a doctor’s brain to solve some of the questions we face in the lab that are a requirement in other settings. “
The global reaction to the continent that followed Omicron’s identity shaped in his brain why Africa will have to be self-sufficient.
“I felt it was an unscientific answer,” Maranyane says of the bans. “It was as if, to some extent, we weren’t necessarily in the same boat. “style on how Africans can cope with pandemics in the long term.
She arrives at the lab around 8 a. m. , her braided hair tied up. His gaze alert, muttering behind a surgical mask the chemical formulas he had memorized the night before. She is the last to leave the office.
“It’s almost set in stone that if you need to do science in Africa, in South Africa, it’s a pipe dream, so I feel very privileged to be living the chimera now,” she says.
What’s transparent about spending time in Abrigen’s lab is how united this tough team of 20, largely made up of women scientists, is in their vision of Africa as the repository of disruptive science.
A February investigation via the British Medical Journal found that the kENUP Foundation, a consulting firm contracted through BioNTech, had asked the South African government to close Afrigen and the WHO centre. The sustainability clients of this WHO Center Vaccine Technology Transfer allocation are favorable,” kENUP said in papers received through the journal. BioNTech responded to Al Jazeera’s requests for comment.
Instead of sharing revenue, BioNTech and Moderna plan to build their own vaccine plants in Africa. Critics argue that these startups, announced after the AFRIGEN center, are a smokescreen to share the generation that would wipe out profits.
In aArray Moderna told Al Jazeera that while it “has filed patents in South Africa and many other countries similar to the COVID-19 vaccine and Moderna’s platform technology,” the company “is committed to ensuring that our intellectual property, or considerations about the application of our intellectual property, do not constitute a barrier to access. Moderna’s proposed mRNA installation in Kenya has “strong support from the U. S. government. “U. S. ambassador added U. S. Ambassador “I’m in the U. S. in Kenya, Meg Whitman,” he said.
Meanwhile, Pfizer-BioNTech announced an agreement in July last year with the Cape Town-based Biovac Institute. This is a bottle-and-package partnership starting this year, which comes with the wisdom of the main element of the vaccine.
Pfizer highlighted the demanding situations of building local production in Africa. Patrick van der Loo, Pfizer’s regional president for Africa and the Middle East, said at a convention in Rwanda. Biovac Institute,” whose component “provides vital education on workforce progression to health professionals in South Africa. “Angira added that vaccine production “is extremely complex in all circumstances, and even more so in a pandemic. “
Charles Gore is the executive director of the Medicines Patent Pool, a United Nations-backed nonprofit that works to make medical remedies and technologies available to low- and middle-income countries. He says African production is a matter of self-sufficiency. “These are not globally evolved corporations that are establishing subsidiaries in Africa,” Gore says.
“In terms of vaccines, at the beginning of the pandemic we were essentially told, ‘Go away. They have no role to play in the production of generic vaccines,” Gore says.
“There’s certainly a lot more confusing than generating a small molecule, but unfortunately the pharmaceutical industry refused to talk to us about whether demanding situations can be overcome,” he says.
African fitness staff say the continent has already experienced such resistance. Although South African patients are participating in clinical trials of HIV and AIDS drugs, the burden of drugs on the market is too high for many others who desperately need them.
In 1997, then-South African President Nelson Mandela signed a law granting the state the right to import and produce reasonable generic versions of beloved HIV and AIDS drugs with the permission of patent holders.
This allowed the government to establish a constant value for the drugs and the amount of royalties paid to the patent holder, reducing the price of HIV drugs by up to 90%.
This progression came after 20 years of frustration in which, due to inequalities, more people died in African countries after the arrival of effective antiretrovirals than before the arrival of the drugs.
Nearly 40 pharmaceutical corporations sued South Africa in 1998. The country has been placed on a U. S. watch list of countries that violate foreign patent rights. But the corporations faced a backlash and in 2001 dropped their lawsuit.
Today, Afrigen and WHO have faced a challenge.
According to a 2021 report by researchers at Yale University in the US, low-income countries participating in COVID vaccine trials, as well as South Africa, received fewer doses of the vaccines than helped than the richer countries. High-income nations also got those doses before the poorest.
Max Lawson, co-chair of the People’s Vaccine Alliance and head of inequality policy at Oxfam, calls it a “crime of historic proportions” for European countries to hold their pharmaceutical corporations and vaccine source for years.
In March, Johnson executives
Africa had gone from a lack of vaccines to a flood of donations “a year and a half too late,” Lawson says. This after a point where richer countries had vaccinated more than 80% of their population.
“The tendency to give creates a deceptive and harmful addiction,” Gore told Al Jazeera. “Recipients get used to the things they are given and therefore expect them, which means they don’t put the resources to do their own development. “. “
Fatima Hassan, a human rights defender who heads the Health Justice Initiative in South Africa, says Johnson’s vaccine
Johnson
When I first spoke with Terblanche in January, Afrigen aimed to boost clinical trials. But the company faced a pharmacy festival about U. S. -made raw fabrics. The U. S. and European efforts to expand COVID vaccines made by Moderna, Pfizer-BioNTech and Johnson.
For two years, India and South Africa, subsidized by almost each and every African country, pushed World Trade Organization (WTO) member countries to give up intellectual asset protections for COVID vaccines so that production can take a position on the continent without lawsuits from pharmaceutical companies. Companies.
Reacting to the criticism, Moderna pledged in March to “never enforce” its COVID vaccine patents against brands in 92 poorer countries. South Africa is not on the list. Instead, Moderna has registered a wide diversity of patent protections in the country.
In June, the WTO agreed to a partial exemption from the patent, which forces governments to force pharmaceutical corporations to percentages of their vaccine formulations over the next five years, with “adequate” compensation.
Behind the scenes, a race is underway for the next generation of mRNA vaccines targeting a variety of other diseases. Moderna and BioNTech are conducting clinical trials against influenza, HIV, dengue, Zika, hepatitis and malaria. the back of the list. This is precisely what Afrigen scientists seek to prevent.
It is possible to reshape access to medicines for diseases that affect African countries, Maranyane told Al Jazeera. In the event of a new pandemic, African manufacturers could simply manufacture their own mRNA injections on a large scale, Fenner says.
“Outside of a pandemic, the idea is for those specific companies to focus on diseases of interest in their area,” he says. Nigeria, for example, might choose to focus on Lassa fever. It is caused by a virus that kills miles. de other people in the region each year and which, according to epidemiologists, may be the next pandemic. Several potential vaccines are being developed, but largely through researchers in North America.
Such attempts to solve such demanding situations make scientists like Lees and Maranyane more likely to continue working in Africa than looking for opportunities abroad.
Fenner knows all too well the struggle facing young scientists in Africa. Like many other people of color in South Africa, Fenner, a fourth-generation South African of Indian descent, grew up in a network of combined heritage that affected racist apartheid legislation. .
“When I talk about my adventure, I say I’m one of those who overcame adversity because not everyone had the same chances to fight,” she says. “My parents, not having had every opportunity to have them, didn’t even finish school. They have made it a priority that all young people finish their studies and that we have some kind of higher education.
Opportunities for scientists were in academia, but required researchers to offload outside grants. For Fenner, who spent five years as an educational researcher after earning a doctorate in biotechnology, it has become “a big challenge. “
In addition to coaching and mentoring PhD students, “you also had to spend time with this tension of bringing your own salary,” he says. As a result, he left the academy and went on to paint in Afrigen. “I haven’t looked back since, and it’s been almost six years,” he says.
“We lobbied the South African government to devote a certain percentage of the country’s GDP to the clinical setting,” he added. “The budget just wasn’t there. “
Part of the impulse is to fill in the gaps of some. As of July, at least 12 vaccine brands were preparing to gain Afrigen’s mRNA expertise. About $95 million is needed to fund Afrigen’s vaccine initiative over the next five years. More than 60% of that has been secured, says Terblanche. The money came from the European Commission and individual governments, plus South Africa, France, Belgium and Canada.
Africa accounts for less than 1% of global research production. Since the 1990s, one in 3 African scholars and scientists has left the continent each year, according to UNESCO.
“If you have cutting-edge corporations that are doing really exciting science, the other people will stay because there are opportunities to tap into the cutting edge of things in Africa,” Gore said.
Experts in the chart say mRNA vaccines involve fewer ingredients and capacity than classic vaccines. Influenza vaccines are available in poorer countries. “It’s a very flexible technology,” he says Kieny. No wants to buy very expensive stainless metal appliances that are used to produce vaccines.
The big question, however, is whether African governments can maintain the obligatory political and monetary commitment over time. So this is the biggest conversation. Will the governments we’re in and the express countries where the shelves [manufacturers] are located inspire local production and say, “Yes, we’ll buy vaccines from them”?
African public health officials prioritize vaccine production as a national strategy because, crucially, vaccine developers are in business to make a profit and will prioritize markets where their sponsors are located, says Bartholomew Dicky Akanmori, regional advisor for vaccine studies and regulation for WHO. across Africa.
“COVID-19 has taught us that there are inequalities in access to physical activity and that when it comes to a scenario like the pandemic, countries rightly deserve to put their other people first,” he says. “But if African governments start making an investment in their own studies and development, they will eventually own the intellectual property. “