Sahpra approves use of China's Sinovac vaccine for South Africans

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  • The Chinese manufactured Sinovac vaccine has been approved in South Africa.
  • The South African Health Products Regulatory Authority has given it the nod, with some conditions.
  • Sahpra said the authorisation was based on data submitted between March and June.

The South African Health Products Regulatory Authority (Sahpra) has authorised the administering of the Sinovac Covid-19 vaccine, under certain conditions.

One of Sahpra's conditions is the submission of periodic safety data.

"This authorisation is based on the safety, quality and efficacy data submitted by Curanto Pharma (Pty) Ltd to Sahpra between 22 March 2021 and 22 June 2021.

"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 Organisation (WHO) Emergency Use Listing (EUL) report on this vaccine," said Sahpra.

The health products authority had previously said that it was guided by science and available data before it could approve any vaccine. It raised concerns about the efficacy of Sinovac and Sputnik vaccines against the Delta variant, saying it needed more data from the manufacturers before it could approve their usage. 

This came in the wake of a march to Sahpra offices in Pretoria last week by the Economic Freedom Fighters (EFF), who demanded the approval of Sputnik and Sinovac within seven days.

READ | Malema gives Sahpra 7 days to approve Sputnik, Sinovac vaccines - or else more protests

According to Sahpra, Sinovac side-effects included pain at the injection site, headache, fatigue, muscle pain, diarrhoea and nausea. Most of the side-effects were mild or moderate in nature and cleared within a couple of days.

Sinovac can be taken by people between the ages of 18 and 59. It has two doses, with the second one to be taken after 14 to 28 days.

The jab has a provisional shelf life of two years.

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