SAHPRA approves Sinovac’s two-dose COVID-19 vaccine, with conditions

The approval of the Chinese vaccine seen as a major boost to rollout programme as new cases soar.

On Saturday, the South African Health Products Regulatory Authority, SAHPRA, announced it had authorised the CoronaVac COVID-19 vaccine. The vaccine is manufactured by Chinese pharma Sinovac and is imported by Curanto Pharma. According to its statement, SAHPRA highlighted that the authorisation was done in terms of Section 21 of the Medicines Act, which enables emergency use access and also enables SAHPRA to authorise a medicine subject to certain conditions. It is the same type of authorization granted to Pfizer/BioNTech’s and AstraZeneca’s COVID-19 vaccines earlier in the year. Under the terms of the of the approval, the two-dose vaccine will be used in individuals aged between 18 and 59 years, with the second dose administered between 14 and 28 days after the first.

In the days prior, the Economic Freedom Fighters tried to put pressure on the regulatory authority to register the Sinovac and Sputnik vaccines for use in the country. However, SAHPRA had stuck to its guns, making it clear it that while it was working around the clock to fast-track approvals for COVID-19, it would not compromise on the rigorous science required to meet approval requirements. Coincidentally, the approval came on the same day the country reported 26,485 new cases – the highest on record. On Sunday, the number retreated somewhat, with 16,585 new cases being reported. However, 333 more people died due to the disease on Sunday, bringing the total number of deaths to 61,840. With just 3 314 278, or less than 2% vaccinated to date, health authorities welcome the approval.