Not enough data to approve Sputnik V, Sinovac, says Sahpra
The South African Health Products Regulatory Authority (Sahpra) insists there is not enough data to approve the Russian Sputnik V and Chinese Sinovac vaccines.
Sahpra chairperson Professor Helen Rees made the remarks at a media briefing hosted by acting Health Minister Mmamoloko Kubayi-Ngubane on Friday.
“For the Sputnik there are two applicants and what they are doing is called a rolling review so as they get data they are submitting it to the regulator and the regulator is reviewing that data on a continuous basis and that speeds things up. They are still submitting some of that data, so we don’t have that required for a complete review yet.
“Sinovac similarly when they first applied we needed more data and so there’s been ongoing dialogue with the Sinovac applications as with all these applicants for the vaccines. The Sinovac applicants have now submitted to the regulator the same information that they have submitted to the World Health Organisation (WHO).
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“Many of you would’ve heard that the WHO in the last couple of weeks gave what's called an emergency use listing for Sinovac. In the last 24 hours we have received a dossier from the WHO of the Sinovac vaccine. That will definitely speed up what we have.”
The only vaccines that have been approved for use in the country are Astra-Zeneca, Pfizer and Johnson & Johnson.
On Thursday, the country bridged the 2 million mark in the number of Covid-19 vaccines that have been administered.
However, there has been growing criticism towards the country’s slow vaccination programme that began in March.
Some critics are accusing the government of placing "political pressure" at Sahpra.
But Rees has denied the claims.
“In terms of the political pressure, the pressure has been the country’s pressure. Everything has required urgent attention and creative thinking around the legislation and everything has had to be fast tracked. At no stage have we had political pressure around vaccine A or B or C or D. I can say that with absolute certainty.”
