Afrigen Biologics & Vaccines plans to start human trials of its Covid-19 vaccine candidate by May, part of a World Health Organization-backed plan to develop locally-made inoculations in the developing world.
Afrigen, which is part of the WHO’s mRNA vaccine technology transfer hub in Cape Town, said in a joint statement the vaccine has shown “a strong immune response” in pre-clinical trials in mice. The vaccine was made by copying the publicly-available sequence of the Moderna Inc. shot provided by Stanford University.
The next stage, the so-called phase 1, 2 trial, will involve about 150 people at sites near Cape Town with the aim of including both vaccinated and unvaccinated people and proving whether it can be used as an initial dose or a booster, said Petro Terblanche, Afrigen’s managing director.
The WHO set up the hub, its first, in June last year to address concerns poor countries weren’t getting sufficient access to life-saving Covid shots as the bulk of them went to affluent countries where major vaccine producers such as Moderna, Pfizer Inc. and BioNtech SE are based.
The locally-developed shots could end up being made by at least 15 production facilities in low and middle income countries around the world.
“This is the vaccine candidate that will validate the platform,” Terblanche said.
Vaccines made using messenger RNA are a breakthrough technology brought into commercial production for the first time during the pandemic. Messenger RNA can be adjusted to tackle different pathogens, potentially accelerating the development of new shots.
Ultimately the WHO plans to follow the production of a Covid-19 vaccine with an attempt to develop inoculations for neglected diseases that plague the citizens of poor countries such as tuberculosis, HIV-AIDS, some forms of cancer and hemorrhagic fevers Ebola, Lassa fever and the Marburg virus.
“This is the single most exciting project in global public health,” said Charles Gore, the director of the Medicines Patent Pool, which is helping the WHO establish the hub. “It’s about empowerment,” he said at Afrigen’s laboratories in Cape Town on Monday.
Afrigen plans to transfer the technology to companies in countries including Argentina, Senegal, Bangladesh and Ukraine so that they can mass-produce it. It’s also seeking to improve the thermostability of the vaccine to allow it to be stored at normal refrigerator temperatures rather than the ultra-cold storage Moderna’s shot needs.
The first company to receive the technology will be the Biovac Institute in Cape Town, a partly government-owned company that already fills and packages vaccines for other diseases under arrangements with companies including Pfizer and Sanofi. Other companies include Biological E Ltd. in India and the Torlak institute in Serbia.
Initial attempts to get Pfizer and Moderna to assist the WHO and its hub to develop the vaccine were largely rebuffed and that’s slowed its progress, according to the WHO and Afrigen. Wide-ranging mRNA patents held by Moderna in countries including South Africa are also a threat to its future success, according to Gore.
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With “the inequity that’s been exposed here, nobody public relations wise can really afford to be seen to be doing something that continues that inequity,” Gore said.
Moderna has said it won’t enforce its patents to block the production of Covid-19 vaccines in poorer countries while the pandemic is still raging. But it’s unclear whether it would do so if the hub and other companies seek to make shots for other diseases using the mRNA platform that’s being developed.
Health and legal advocacy groups this week sent a letter to South African President Cyril Ramaphosa this week asking him to take action against Moderna’s patents .
“It is vital for the security of the mRNA hub that South Africa either revokes these patents or takes necessary executive actions to manage them,” the groups said in the letter distributed by the People’s Vaccine Alliance.
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The demand for Covid-19 vaccines has slowed because more recent variants of the virus have caused milder disease. But scientists have warned that those who aren’t vaccinated are more likely to experience more severe symptoms. The virus will probably continue mutating and future variants may be more virulent.
The hub is now looking at other diseases including measles and chikungunya, a viral disease spread by mosquitoes. It also aims to develop a shot that will tackle pediatric diseases, Terblanche said.
The success of the hub and the companies it transfers technology to will depend on the willingness of governments and associations such as Gavi, the global vaccine alliance, to buy shots that initially may cost more than those made by large pharmaceutical companies.
South Africa’s Aspen Pharmacare Holdings Ltd. won a license to produce Johnson & Johnson’s Covid-19 vaccine shot and then failed to win any orders from African nations. That was because they were belatedly flooded with vaccines as demand for them waned in richer countries and they struggled to get their own citizens to take them.