Approval of a messenger RNA COVID-19 vaccine produced at a technology transfer hub in South Africa could take up to three years if companies do not share the technology around the vaccines they’ve produced, said Martin Friede, coordinator at the World Health Organization’s Initiative for Vaccine Research, during a press conference Friday. If an mRNA vaccine producer agrees to cooperate, the process would only take about 12 to 18 months.
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The technology transfer hub, set up last year, is working to help lower-income countries build up the capacity to produce mRNA vaccines. The know-how from the hub will be transmitted to vaccine producers such as The Biovac Institute in South Africa, as well as companies in Argentina and Brazil.
Successful replication: On Thursday, South Africa's Afrigen Biologics and Vaccines, a partner in the hub, announced it was successful in replicating Moderna’s vaccine by using publicly available information, without the company’s support. The hub chose to copy this vaccine because Moderna has committed to not enforce its patents during the pandemic.
Extended time frame: Without the participation of outside companies, the hub will need to conduct new clinical trials for its vaccine candidate to gain approval. The clinical trials are expected to start in the fourth quarter of this year.
The process would be hastened and trials would not have to be duplicated, Friede said, if technology is shared either by companies with approved COVID-19 vaccines — such as Moderna, Pfizer, and BioNTech — or by organizations that are in the midst of or starting final-stage clinical trials, as is the case for some companies in China, Thailand, and India.
Friede added that the hub will work to create second-generation technology — such as vaccines that don’t require the low temperatures needed by the current mRNA COVID-19 vaccines, which make them more difficult to roll out in low-resource settings.