A South African biotech said it made a Covid-19 vaccine candidate that matches the one by Moderna Inc. after the U.S. developer rebuffed its request for a partnership. Getting it across the finish line, however, could take years without support from the industry.
Afrigen Biologics & Vaccines, part of the World Health Organization's mRNA technology transfer hub in Cape Town, obtained the publicly available sequence of the Moderna shot from Stanford University and has now made its own version, said Petro Terblanche, its managing director.
Without help from a developer of an approved mRNA vaccine, it could take about three years to gain approval, Martin Friede, a vaccine research coordinator at the WHO, told reporters on Friday. If one of those companies opted to share technology and data, that could be achieved potentially in about 12 to 18 months, he said. A few biotech companies he didn't identify have shown interest in sharing information, he said.
“This was not as much rocket science as people tried to make it appear, but we now have the challenge of having to scale this up,” he said, adding that a shot could enter human trials later this year.
The WHO set up the mRNA hub in South Africa, its first, in June to address concerns that poor countries weren't getting sufficient access to life-saving Covid shots. The idea was to partner with a major producer of mRNA vaccines, but companies including Pfizer Inc., BioNTech SE and Moderna declined the WHO's request to share technology and expertise.
“That didn't happen,” Terblanche said. “We put a team together and moved on.”
Afrigen, a laboratory that makes materials that can be used in vaccines, is doing final tests and will transfer the technology to larger companies that can make the substance on a bigger scale. The hope is that the work will pave the way for broader mRNA vaccine development and distribution in the future.
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The initial transfer will be to the BioVac Institute, also in Cape Town, followed by Sinergium Biotech SA in Argentina and Brazil's Fundacao Oswaldo Cruz Foundation, she said.
The vaccine still needs to go through clinical trials and it could be two years before a license can be sought and the shot rolled out to the general population, she said. Afrigen is permitted to make the vaccine especially as it is still in an experimental stage, she said. Moderna, which declined to comment, has previously said it won't enforce its patent during the pandemic.
“The sequence is in the public domain,” Terblanche said. “We have freedom to operate.”
Good Location
South Africa is a good place to hold the trials because of its medical expertise, ethnically diverse population and a high prevalence of co-morbidities, she said.
While the vaccine may not be available for some time, it demonstrates the technical capability of Afrigen. The company is looking at making another Covid-19 shot itself that won't need to be stored at the ultra-low temperatures required by Moderna's vaccine, and will ultimately look to tackle diseases prevalent in Africa such as HIV, tuberculosis and malaria, she said.
Moderna, whose Covid shot has yet to reach vast parts of the world, plans to spend as much as $500 million to build a factory in Africa that could make half a billion mRNA vaccine doses a year. Yet health advocates have urged the company to support the WHO initiative already underway rather than pursue its own project.
The development was reported earlier by Reuters.
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