Approval of COVID vaccine made in South Africa could take 3 years, WHO says

European delegation visits WHO's mRNA vaccine hub in Cape Town
A production scientist works with samples during a visit by representatives of the Medicines Patent Pool, France and other European Union member states, at the Afrigen Biologics' site in Cape Town, South Africa. REUTERS/Shelley Christians/File Photo

Feb 4 (Reuters) - The mRNA-based COVID-19 vaccine produced at the World Health Organization-backed vaccine hub in South Africa could take up to three years to get approval if companies do not share their technology and data, a WHO official said on Friday.

The WHO-backed tech transfer hub in South Africa was set up in June to give poorer nations the know-how to produce COVID-19 vaccines, after market leaders of the mRNA COVID vaccine, Pfizer (PFE.N), BioNTech (22UAy.DE) and Moderna (MRNA.O), declined a WHO request to share their technology and expertise.

Martin Friede, coordinator of the WHO Initiative for Vaccine Research, said if companies with approved COVID vaccines or late stage clinical data shared their technology and data with the consortium, the vaccine produced in South Africa could be approved in 12 to 18 months.

"..It could be 12 months if there was a partnership with a company that already has an approved vaccine. Otherwise, it's more like 24 to 36 months depending on what the approval process is."

On Thursday, South Africa's Afrigen Biologics, which was part of WHO's consortium, said it has used the publicly available sequence of Moderna's mRNA vaccine to make its own version of the shot.

The WHO has been trying to persuade Moderna and Pfizer-BioNTech to join forces with its African tech transfer hub.

Friede said the vaccine will be going into first clinical trials in fourth quarter of this year.

"Now have the challenge of having to scale this up. And this is of course where we're going to run into some challenges."

Reporting by Mrinalika Roy in Bengaluru Editing by Raissa Kasolowsky

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