Decision on Sputnik V expected late in third quarter – Sahpra
A decision on the approval of the Russian Covid-19 vaccine is only expected in the later part of the third quarter.
This is according to South African Health Products Regulatory Authority (Sahpra) chairperson Professor Helen Rees.
“The emergency use license from the World Health Organisation (WHO) hasn’t been given yet to Sputnik and that is because they’re continuing to submit data,” she told Parliament’s health committee on Wednesday.
“It is only anticipated that there will be some announcement later on in the third quarter of this year.”
If approved, the Sputnik V will form part of the list of three other vaccines used in the fight against Covid-19 in South Africa,
They include Johnson & Johnson, Pfizer, Astra-Zeneca and recently approved Sinovac.
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Sahpra CEO Dr Boitumelo Semete told MPs the regulatory body has also received outstanding data for the Sputnik, which they will continue evaluating.
Dr Semete says the data that was missing from the Sputnik V applicants included safety, efficacy and quality.
"So when it comes to Sputnik there was data outstanding on all these three metrics.
“We’ve had a number of engagements with the applicant because it was a rolling review in a section 21 review mechanism. So in terms of the data of the safety and efficacy, they have provided us with the data that we requested and we are busy evaluating that. We are also busy evaluating the quality aspects and that speaks to the manufacturing side of that.
“So what we requested for we have received and are busy evaluating. And depending on the quality of the submission of the data that we asked for we will either continue to engage until we are satisfied or they may well satisfy us now. So we are busy evaluating what has been provided to us.”
