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Sputnik vaccine’s backers attack SAHPRA over emergency authorisation

SA’s medicines regulator has come under attack from the financial backers of the Russian COVID-19 vaccine Sputnik V, claiming its failure to grant the product emergency use authorisation threatens to torpedo plans to set up a manufacturing site in Cape Town.

Business Day reports the Russian Direct Investment Fund (RDIF) financed the Gamalaya Institute’s development of Sputnik V – the first COVID vaccine registered for use in any country and now used in more than 70 nations, including Hungary, Brazil and Zimbabwe. The shot has yet to be approved by any of the regulators with which the SA Health Products Regulatory Authority (SAHPRA) aligns itself like the European Medicines Agency.

Lamar International, the local representative for the RDIF and the Gamalaya Institute, applied to SAHPRA for emergency use authorisation for Sputnik V in February after The Lancet published data showing the vaccine had 92% efficacy. “We would like to build a vaccine production facility that can create jobs, but do not have authorisation,” said RDIF’s Southern Africa representative, Artem Grigorian. “We can invest R500m, R1bn, for one (vaccine production line) but would like to do more to (tackle) other diseases.”

He said the plant would make active pharmaceutical ingredients, and formulate and bottle the shots to supply SA, other Brics countries and the rest of Africa. A site had been identified near Cape Town Airport, but the project was being delayed by SAHPRA’s red tape.

 

Business day article – SA medicines regulator accused of blocking Sputnik vaccine (Restricted access)

 

See more from MedicalBrief archives:

 

Russia's Sputnik V vaccine is 91.6% effective — Phase 3 results

 

EFF: SAHPRA refusal to allow Sinovac and Sputnik condemned

 

Russia’s Sputnik V about 90% effective against Delta variant — Developer

 

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