CoronaVac approved for use

The SA Health Products Regulatory Authority (Sahpra) has approved the CoronaVac vaccine developed by Sinovac. Picture: FILE

The SA Health Products Regulatory Authority (Sahpra) has approved the CoronaVac vaccine developed by Sinovac. Picture: FILE

Published Jul 4, 2021

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The SA Health Products Regulatory Authority (Sahpra) has approved the CoronaVac vaccine developed by Sinovac. Picture: FILE

Following the announcement that CoronaVac manufactured by Sinovac Life Sciences is approved for use in South Africa, Western Cape Premier Alan Winde said he wants to “get his hands on it as soon as possible”.

The country remains the continent’s worst hit, with a new record of over 26 000 cases on Saturday.

"We are indeed... in the eye of the storm of the third wave," Deputy Health Minister Joe Phaahla warned.

Winde has established a Covid-19 vaccine procurement team with the aim of the provincial government, buying vaccines separately from the national Health Department rollout.

Yesterday, the South African Health Products Regulatory Authority (Sahpra) confirmed that CoronaVac has been approved for use in SA with some conditions.

In a statement the national health department said: “This authorisation is based on the safety, quality and efficacy data submitted by Curanto Pharma (Pty) Ltd to Sahpra between 22 March 2021 and 22 June 2021. Although the data submitted are considered acceptable at this point, the authorisation is subject to a number of conditions. Specifically, the applicant is required to submit the final results of ongoing clinical studies. Sahpra also took account of the World Health Organization Emergency Use Listing report on this vaccine.”

Acting Minister of Health Mmamoloko Kubayi welcomed CoronaVac’s approval and said: “This approval came at the time when the government is implementing an expanded and multipronged vaccination programme to reach as many people as possible, while the infection numbers continue to increase at an alarming rate. This will enable the government to initiate procurement processes to secure more vaccines... On behalf of the department, I would like to express gratitude to our regulatory authority for their sense of urgency.”

The Covid-19 Delta variant is spreading rapidly across the country and studies on CoronaVac’s efficacy against this variant have yet to be completed and made public.

Professor of Vaccinology at the University of the Witwatersrand Shabir Madhi said CoronaVac has its benefits: “From the studies that were done it reduces the risk of Covid-19 by between 50 to 60%, but that's against our regional virus. When it comes to severe disease and hospitalisation, it sort of provides around about 90 to 100% protection...so it works extremely well.”

He added: “We don’t know about the Delta variant, so I would expect that against the Delta variant effectiveness against mild disease would be lower than 50 to 60%, slightly lower but against severe disease it should still maintain high levels of protection.”

A Sahpra statment said it need further research. “The conditions require the submission of periodic safety updates in accordance with Sahpra guidance, and conformance with pharmacovigilance activities. As outlined in the clinical trial evidence submitted by the applicant, most of the side effects following administration of the CoronaVac vaccine were mild or moderate in nature, and cleared within a couple of days. The frequently-reported adverse reactions were: pain at the injection site, headache, fatigue, muscle pain, diarrhoea and nausea.”

Winde is keen to get as many vaccines to the Western Cape as quickly as possible and he said CoronaVac is no different.

Winde added getting vaccines directly to the province is likely in the near future: “Even the existing two vaccines that we currently getting supplied in South Africa, that's the Johnson & Johnson and Pfizer - their global CEOs both indicated to us that they can’t supply at present... but they also indicated to us that's at present and so maybe in August/September things could change.”