The South African Health Product Regulatory Authority (Sahpra) has approved the use of Chinese produced vaccine Sinovac in South Africa.
This was announced by the health regulatory body in a statement on Saturday.
“The Sahpra has authorised the CoronaVac COVID-19 vaccine, manufactured by Sinovac Life Sciences Co, and imported by Curanto Pharma (Pty) Ltd,” reads the statement.
“The authorisation 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 authorise a medicine subject to certain conditions.”
It said that the vaccine is indicated for active immunisation in individuals aged between 18 and 59 years against Covid-19.
“The vaccine is administered as two doses of 0,5ml, given intramuscularly, with the second dose administered between 14 and 28 days after the first dose.”
Sahphra said the approval of the vaccine was also subject to a number of conditions.
“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,” reads the statement.
“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.”
It said clinical trial evidence submitted by the applicant showed most of the side effects following administration of the CoronaVac vaccine were mild or moderate in nature, and cleared within a couple of days.
“The frequently-reported adverse reactions were: pain at the injection site, headache, fatigue, muscle pain, diarrhoea and nausea.”
Health department grateful
Acting health minister Mmamaloko Kubayi said in a statement on Saturday that the approval of the Coronavac vaccine was a “turning point” for South Africa’s vaccine rollout.
She said the approval came at a time when the vaccination programme was being expanded to reach as many people as possible, while also trying to balance soaring infection rates.
“I would like to express gratitude to our regulatory authority for their sense of urgency, which included reducing turnaround time to process applications for registration of medical products, COVID-19 vaccine in particular – without compromising their strict guidelines to ensure the safety of our people.”
She added that more information about the vaccine, including its efficacy against the dominant Delta variant, will be made public once Sahpra submits its formal report.
Last month, Sahpra revealed that applications had been received for the Sputnik V and Sinovac’s Coronavac vaccines, and that the evaluation of the Coronavac application was at an advanced stage.