The Sputnik V vaccines. Photo: Russian Direct Investment Fund
  • Health minister Zweli Mkhize has indicated that the authorities may soon make a decision on allowing the Sputnik vaccine in South Africa.
  • The Russian producers of the vaccine are currently testing it on the the 501Y.V2 variant
  • Results could be released within days, a prospective importer said.
  • For more articles, go to www.BusinessInsider.co.za

Health minister Zweli Mkhize on Wednesday confirmed that the authorities are in “advanced stages of evaluating” the Sputnik V Covid-19 vaccine, as its producer considers the vaccine’s efficacy against the 501Y.V2 variant first identified in South Africa.

A spokesperson of the Russian Direct Investment Fund (RDIF), Russia's sovereign wealth fund, told Business Insider that Sputnik V is currently being tested against the South African variant. The RDIF manages the production and distribution of the Sputnik V vaccine, which was developed by the government-owned Gamaleya Institute.

The RDIF referred Business Insider SA to two South African pharmaceutical companies – Lamar International and Pharma-Q - to confirm details of “the status of shipments to South Africa”.

A Lamar International spokesperson told Business Insider this week that the Gamaleya Institute’s laboratory results on its vaccine’s efficacy against 501Y.V2 are expected within days. The findings will be submitted to the  South African Health Products Regulatory Authority (SAHPRA), which is currently deciding on whether to register Sputnik for emergency use.

According to a ministry of health briefing to cabinet, Lamar and Pharma-Q can together supply 23 million doses of the vaccine to South Africa.

While Mkhize said government is "engaging" with the Sputnik manufacturers directly, it is not clear why it is apparently procuring the vaccines via third parties. For other vaccines, it is dealing directly with the manufacturers, or working through the global Covax initiative.

Lamar International says it has been allocated 15 million doses of the vaccine.

Pharma-Q managing director Anand Mehta also confirmed that his company has been “authorised” to import Sputnik V too and has made a proposal to the Ministry of Health.

“Upon approvals we will be able to give timelines for importing the vaccine,” Mehta says.

New rollout strategy

South Africa has been sent back to the drawing board after the health department halted the distribution of the Oxford/AstraZeneca vaccines. This after a new study found the vaccine provided minimal protection against the 501Y.V2 variant identified in SA. 

For now, government has pivoted to the Johnson & Johnson vaccine, which shows higher levels of protection as part of a new rollout strategy. But the Sputnik, and China's Sinovac vaccine may also form part of the local offering.

Russia started using the Sputnik V vaccine in August 2020, becoming the first country in the world to approve a coronavirus vaccine. Two million people have already received the vaccine. It has been approved for use in a number of countries including Iran, Mexico and Argentina. On Monday, Hungary became the latest to approve Sputnik. The Philippines is currently in talks for 25 million doses, Fortune reports.

A peer-reviewed study published in the international science journal The Lancet last week showed the vaccine to be 92% effective after two doses (three weeks apart), in a trial of 20,000 people. This is among the highest efficacy rates reported for Covid vaccines.

However, there are as yet no findings to prove whether Sputnik would be effective against the 501Y.V2 variant.

Sputnik is based on a genetically engineered adenovirus – a common virus that causes flu and colds - which renders the Covid virus harmless. The vaccines need to be stored at two to eight degrees Celsius. The Sputnik vaccine is estimated to cost $20 (R300) for two doses, cheaper than Pfizer ($26), Moderna ($60) and China's Sinovac ($27). But it is more expensive than AstraZeneca ($6).

While Africa Health Research Institute (AHRI) director and vaccinology expert Professor Willem Hanekom told the SA health publication Spotlight that the Sputnik results were rigorous, he noted the lack of diversity in its trial - only white males were included and there is no mention of its efficacy on HIV. 

 

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