HomeNewsApproval of COVID vaccine made in South Africa could take 3 years,...

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

A production scientist works with samples during a visit by representatives from the Medicines Patent Pool, France and other member states of the European Union, to the Afrigen Biologics facility in Cape Town, South Africa.  — Reuters/File photo
A production scientist works with samples during a visit by representatives from the Medicines Patent Pool, France and other member states of the European Union, to the Afrigen Biologics facility in Cape Town, South Africa. — Reuters/File photo
  • The mRNA-based COVID-19 vaccine will take up to three years to gain approval if companies don’t share their technology.
  • If companies share their technologies, the vaccine produced in South Africa could be approved in 12 to 18 months.
  • South Africa’s Afrigen Biologics has used the publicly available sequence of Moderna’s mRNA vaccine to create its own version.

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 gain approval if companies don’t share their technology and data, a WHO official said Friday.

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

Martin Friede, coordinator of the WHO Vaccine Research Initiative, said that if companies with approved COVID-19 vaccines or late-stage clinical data shared their technology and data with the consortium, the vaccine produced in South Africa within 12 to 18 months could be approved.

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

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

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

Friede said the vaccine will undergo its first clinical trials in the fourth quarter of this year.

“Now have the challenge of scaling this up. And of course we’re going to run into some challenges here.”

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