SOUTH AFRICA – South Africa’s health products regulator has declined to approve Russia’s Sputnik V Covid-19 vaccine due to concerns about its safety for people at risk of HIV.
The decision was based on earlier studies testing the safety of a modified form of adenovirus, a type of virus that causes respiratory infections, known as the Ad5 and contained in the Russian jab.
“Use of the Sputnik V vaccine in South Africa, a setting of a high HIV prevalence and incidence, may increase the risk of vaccinated males acquiring HIV,” the South African Health Product Regulatory Authority (SAHPRA) said in a statement.
It noted that the company behind the application for the use of Sputnik V in South Africa had no proof the formula would be safe in settings of high HIV prevalence.
South Africa has one of the world’s highest HIV burdens, and some studies have suggested that administration of vaccines using the Adenovirus Type 5 (Ad5) vector, which Sputnik V does, can lead to higher susceptibility to HIV in men.
Viral vector vaccines like Sputnik V use modified viruses as vehicles, or vectors, to carry genetic information that helps the body build immunity against future infections.
SAHPRA, the regulator, said it had asked for data demonstrating Sputnik V was safe in settings with high HIV prevalence, but that it had not received enough to establish this.
“The rolling review of the Sputnik V vaccine will, however, remain open for submission of relevant safety data in support of the application,” it added.
Russia’s Gamaleya Center, which developed Sputnik V, said it would produce information to show that SAHPRA’s concerns were “completely unfounded.”
The institute pointed to several clinical studies on over 7,000 participants that showed there was no statistically significant increase of HIV-1 infection among adenovirus type-5 vectored vaccine recipients when all study participants and follow-up time were considered.
South Africa, which has bilateral deals for the two-dose Pfizer and one-shot Johnson & Johnson vaccines, has now administered more than 20 million doses.
The country, which has been most hit by the pandemic in Africa, has been struggling with vaccine hesitancy. Around 14 million people have had at least one dose of vaccine, representing 35% of its adult population.
South Africa is this week set to begin vaccinating children as young as 12 and offering booster shots to certain immuno-compromised citizens.
The Chinese-made Sinovac has also been approved. The World Health Organization has not yet given Sputnik V the green light for emergency use, although it is being administered in at least 45 countries.