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SAHPRA approves CoronaVac COVID-19 vaccine, but with conditions

CoronaVac COVID-19, a vaccine manufactured by Chinese company, Sinovac Life Science for use in South Africa, has been hailed as a watershed moment in the country’s immunisation programme.

The South African Health Products Regulatory Authority (SAHPRA) believes that the provided information is acceptable at this time, but the approval remains subject to a number of conditions.

“It is expected that the manufacturer will also submit the final results of the ongoing clinical trials,” said SAHPRA.

In granting this conditional authorisation, SAHPRA said it relied on safety, quality, and efficacy information supplied by the vaccine manufacturer for a period of three months, from March 22, 2021, to June 22, 2021.

Acting Health Minister, Mamoloko Kubayi has welcomed SAHPRA’s authorisation of the vaccine as a key step forward in bringing the immunisation program as the country is embarking on a public vaccination campaign.

The health ministry explains that the move comes as the government conducts a comprehensive vaccination campaign to reach the largest number of people possible, while infection rates continue to spike alarmingly.

The World Health Organization’s Emergency Use List report on the vaccination was also taken into account by regulators, says Kubayi, who expresses hope that the company will disclose any information it has on the product’s efficacy and potential uses.

“On behalf of the Department, I would like to thank our regulatory authorities for their sense of urgency, which includes reducing the time it takes to process medical product registration applications – specifically the COVID-19 vaccine – without compromising their stringent guidelines to ensure the safety of the public,” added Kubayi.

 

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