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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