Saturday, July 03, 2021

SAHPRA approves CoronaVac vaccine

The SA Health Products Regulatory Authority (Sahpra) has approved the use of the CoronaVac Covid-19 vaccine in South Africa.

“The SA Health Products Regulatory Authority (Sahpra) has authorised the CoronaVac Covid-19 vaccine, manufactured by Sinovac Life Sciences Co, and imported by Curanto Pharma (Pty) Ltd,” Sahpra said in a statement on Saturday.

“CoronaVac is an inactivated whole virion vaccine derived from the Sars-CoV-2 virus (CZ02 strain)”. “Each dose contains 600 SU of inactivated Sars-CoV-2 virus as the antigen.

CoronaVac is administered as two doses, with the second dose administered between 14 and 28 days after the first dose.

Sahpra said the authorisation was based on the safety, quality and efficacy data submitted to it by the importer of the vaccine between March and June but emphasised that the approval of the vaccine was not without conditions.

There are however conditions to the jab.

“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,” the statement read.

Sahpra described the side-effects of the vaccine as mild.

“In addition, the conditions require the submission of periodic safety updates in accordance with Sahpra guidance, and conformance with pharmacovigilance activities as outlined in the approved risk management plan.’’


Done By: Mitchum George


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