- Approval has conditions including final clinical study results
- Regulator also weighing emergency-use Sputnik V application
South African regulators have approved Sinovac Biotech Ltd.’s coronavirus vaccine, the first shot developed for the disease by a Chinese company to be sanctioned locally.
The South African Health Products Regulatory Authority backed the double-dose CoronaVac candidate made by Sinovac’s Life Sciences unit with conditions, according to a statement on Saturday. Those include satisfactory results of ongoing studies and periodic safety updates, SAHPRA said.
The acceptance, which has similar terms to those given to other vaccine manufacturers such as Johnson & Johnson, comes as South Africa this week opened its immunization roll-out to people aged 50 and older.
The country is facing a severe third wave as the more infectious delta variant of the disease becomes widespread and only about 6% of the national population has been vaccinated. CoronaVac is indicated for people between the ages of 18 and 59 years and has a provisional shelf life of two years when stored at 2–8 degrees Celsius (35.6-46.4 degrees Fahrenheit) and protected from light, the regulator said.
SAHPRA also took into account the World Health Organization’s emergency use listing report on the vaccine in giving its approval, according to the statement.
Earlier this week SAHPRA Chief Executive Officer Boitumelo Semete-Makokotlela said the regulator is moving faster on the emergency-use application for the Russian-made Sputnik V vaccine after the producer submitted data. The agency has also received an application for the Sinopharm vaccine developed by China.