South Africa’s health products regulator, Sahpra, has withheld approval for Russia’s Sputnik V Covid vaccine over concerns that it could increase the risk of HIV infection among men.
The decision was based on two earlier studies that tested the safety of a modified form of adenovirus contained in the Russian jab.
The Gamaleya Institute, which developed Sputnik V, said it would produce information to show that Sahpra’s concerns were completely unfounded.
The country has the highest HIV burden in Africa. It has about 7.8 million cases of HIV among its population of over 60 million people, according to UNAids. About 13.5% of men aged between 15 and 49 are infected.
Sahpra said its concerns followed consultations with local and international experts.
South Africa has so far approved Covid vaccines manufactured by Pfizer/BioNTech, Johnson & Johnson and the Chinese-made Sinovac.
The World Health Organization has not yet approved Sputnik V for emergency use. The vaccine is however being administered in at least 45 countries including Zimbabwe and Namibia.