The South African Health Products Regulatory Authority (SAHPRA) has authorized Sinovac’s CoronaVac vaccine for use with conditions under Section 21.
The vaccine has been approved for use on people aged between 18 and 59 years.
It will be in two doses given between 14 and 28 days apart. The authority says Sinovac still has to submit the final results of clinical studies and safety data.
SAHPRA says they are continuing to assess safety, quality and efficacy of vaccines amid the spread of new variants of the coronavirus.
SAHPRA CEO Dr Boitumelo Semete-Makokotlela says, “The authorisation was done in terms of Section 21 of the medicines and related Substances Act. This is a mechanism that enables emergency use access and allows SAHPRA to authorise subject to certain conditions. This authorisation is based on the safety, quality and efficacy data submitted by Curanto Pharma to SAHPRA.”
“Although the data is considered acceptable at this point, the authorisation is subject to a number of conditions. The applicant is required to submit the final results of final clinical studies. SAHPRA also took account of the WHO emergency use listing report on this vaccine,” adds Semete-Makokotlela.
SAHPRA’s statement:
