South Africa's Health Products Regulatory Authority has given the green light for the Sinopharm COVID-19 vaccine manufactured in China for use in adults over the age of 18.
Sinopharm and Sinovac's two most widely used COVID-19 vaccines have been shown to be effective against the coronavirus's Delta variant, according to a February study based on real-world data in the country.
South Africa is the African continent's worst-hit country, both in terms of virus-related deaths and cases, and has relied heavily on Johnson & Johnson and Pfizer vaccine doses as it prepares for a possible fifth wave.
Late last year, the African government delayed some vaccine deliveries due to oversupply, as hesitancy slowed uptake.
SAHPRA disclosed in a statement that the authorization of Sinopharm was based on "acceptable safety, quality, and efficacy data submitted by MC Pharma," a local regulatory pharmaceutical company that collaborates with Sinopharm.
It stated that the vaccine was indicated for individuals aged 18 and older, subject to certain conditions, including that it be administered in accordance with the national vaccination program and that periodic safety updates be submitted.
The vaccine is given in two doses via intramuscular injection at a two- to four-week interval, the regulator said in a statement Monday morning.
Additional conditions regarding the reporting of ongoing studies' results and compliance with pharmacovigilance activities as outlined in the approved risk management plan, including the submission of periodic safety updates, it stated.
The vaccine's trial results indicate that adverse effects were typically mild or moderate in severity and resolved within a few days of vaccination. The most frequently reported adverse effects included pain at the injection site, headache, fatigue, nausea and muscle pain.
The South African government has not yet made an official announcement regarding a supply deal or procurement of Sinopharm shipments. Only about a quarter of the country's roughly 60 million-strong population has been fully immunized.
The World Health Organization (WHO) approved a Sinopharm COVID-19 vaccine for emergency use in May. Clinical trial data indicated that it was less effective against symptomatic disease than the Pfizer-developed shot.
The WHO recommended in December that individuals who had received an inactivated COVID-19 vaccine, such as those manufactured by Sinopharm, another Chinese manufacturer Sinovac Biotech, or India's Bharat Biotech, receive a booster dose to protect against waning immunity.
