Regulator ‘blocks SA production of Sputnik vaccine’

 

The Russian Direct Investment Fund, financiers of the development of the Covid-19 vaccine Sputnik V, are blaming the SA Health Products Regulatory Authority (SAHPRA) of preventing them to set up a manufacturing site for Sputnik V in Cape Town.

The Russian Direct Investment Fund, (RDIF)’s SA representative, Artem Grigorian, questioned the scientific expertise of SAHPRA’s staff, saying the questions they had posed about Sputnik V’s safety, efficacy and manufacturing process had been rudimentary. According to Grigorian, RDIF can invest R500-m - R1-bn, for a vaccine production plant that would make active pharmaceutical ingredients and formulate and bottle the shots to supply SA, other Brics countries and the rest of Africa.

SAHPRA’s CEO Boitumelo Semete- Makokotlela said they were working closely with the World Health

Organisation on its evaluation of Sputnik V, which was at an advanced stage.

Sputnik has yet to be approved by any of the regulators that SAHPRA aligns itself with, such as the European Medicines Agency.

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