A South African health regulator has approved China’s Sinopharm COVID-19 vaccine for adults aged 18 and above even though a senior health official said the government would not immediately procure its doses.
South Africa’s Health Products Regulatory Authority (SAHPRA) in a statement on Monday said Sinopharm’s approval was based on "acceptable safety, quality and efficacy data submitted by MC Pharma," referring to a local regulatory pharmaceutical company that has partnered with Sinopharm.
“The registration of these vaccines is a vast stride in vaccine registration as SAHPRA plays its role in the fight against COVID-19,” said the agency’s chief executive Boitumelo Semete- Makokotlela. “SAHPRA will continue to play its part in ensuring the quality, safety and efficacy of all health products, including all vaccines to ensure that the South African public is protected at all times.”
Nicholas Crisp, deputy director-general in the health department, in response to a reporter’s question on whether the government was negotiating the purchase of Sinopharm doses, said they are not procuring (the) vaccine as they have "plenty in stock".
South Africa, the country worst-hit by the pandemic across the African continent, has used the US-manufactured Pfizer-BioNTech and Johnson & Johnson (J&J) shots in its vaccination campaign after signing supply deals with the two major American corporations.
The government, however, delayed some vaccine deliveries late last year because of oversupply as hesitancy slowed the uptake.
A Sinopharm COVID-19 vaccine was approved for emergency use by the World Health Organization (WHO) in May.
Clinical trial data demonstrated that it had lower efficacy against symptomatic disease than the vaccines developed by Pfizer.
The WHO recommended back in December that people who had received an inactivated COVID-19 vaccine like the ones made by Sinopharm, another Chinese manufacturer Sinovac Biotech and India's Bharat Biotech should receive a booster dose to protect against ebbing immunity.
Inactivated vaccines take the SARS-CoV-2 virus and inactivate or kill it using chemicals, heat or radiation.
The vaccine is administered in two doses by intramuscular injection at an interval of two to four weeks, the regulator said in its Monday statement.
The country has so far fully vaccinated about 42 percent of its adult population of nearly 40 million.