Regulator ‘blocks SA production of Sputnik vaccine’

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

The Russian Direct Investment Fund (RDIF) financed the Gamalaya Institute’s development of Sputnik V. It was the first Covid-19 vaccine to be registered for use in any country and is being used in more than 70 nations, including Hungary, Brazil and Zimbabwe.

The shot has yet to be approved by any of the regulators that the SA Health Products Regulatory Authority (Sahpra) aligns itself with, such as 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 shortly 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 we cannot because we do not have emergency use authorisation,” said RDIF’s Southern Africa representative, Artem Grigorian.

“It will not be a small project. We can invest R500m, R1bn, for one [vaccine production line] but we would like to do more to [tackle] other diseases,” he said.

The manufacturing plant would make active pharmaceutical ingredients, and formulate and bottle the shots to supply SA, other Brics countries and the rest of Africa, he said.

A suitable site had been identified near Cape Town International Airport, but the project was being held up by Sahpra’s red tape. “We provided everything on every question they asked, but it was not properly evaluated, never,” he said.

RDIF’s local representative on clinical matters, Sayora 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.

Sahpra came under intense political pressure from the EFF in June to approve Sputnik V and the Chinese vaccine Coronavac. The EFF also threatened senior staff, including CEO Boitumelo Semete-Makokotlela. “That intimidation is still there,” she said, emphasising that Sahpra was only concerned with the safety, efficacy and quality of the products it scrutinised, and not their country of origin.

Sahpra granted emergency use authorisation to Coronavac in July, but it has not been procured by the government.

Semete-Makokotlela said emergency use authorisation was not necessarily a quick process. “We have among the best experts in the country looking at vaccines. Where there is a delay it is because there is a scientific dilemma we are grappling with.”

Sahpra was working closely with the World Health Organization on its evaluation of Sputnik V, which was at an advanced stage, she said.