SAHPRA Authorizes Sinovac’s CoronaVac for Mass Vaccination in South Africa

SAHPRA Authorizes Sinovac’s CoronaVac for Mass Vaccination in South Africa

The South African Health Products Regulatory Authority (SAHPRA) has authorized the CoronaVac COVID-19 vaccine, manufactured by Sinovac Life Sciences Co, and imported by Curanto Pharma (Pty) Ltd. The authorization was done in terms of Section 21 of the Medicines and Related Substance Act 101 of 1965, a mechanism in the Medicines Act that enables emergency use access and also enables SAHPRA to authorize a medicine subject to certain conditions.  TrialSite reported early on that vaccine products out of China should be reviewed carefully, just like those in the West. Although developers in the former were at liberty to take more expedited measures than the latter, growing reports of concern merit close attention.

The Product

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 indicated for active immunization in individuals aged between 18 and 59 years against COVID-19, the disease caused by SARS-CoV-2 virus.

The vaccine is administered as two doses of 0.5ml, given intramuscularly, with the second dose administered between 14 and 28 da...

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