JOHANNESBURG – South Africa’s medicines regulator said on Monday it was not approving an emergency request for the Russian Sputnik V Covid-19 vaccine at this time, citing concerns about its safety for people at risk of HIV.
South Africa has one of the highest HIV burdens in the world, and some studies suggest that administration of vaccines containing the vector adenovirus type 5 (Ad5) – as Sputnik V does – can lead to greater susceptibility to HIV in men.
Viral vector vaccines, such as Sputnik V, use engineered viruses as vehicles, or vectors, to carry genetic information that helps the body build immunity against future infections.
SAHPRA, the regulator, said it had requested data showing that Sputnik V was safe in high HIV prevalence settings, but had not received enough to determine this.
“SAHPRA has decided that the (emergency) request for Sputnik V…will not be approved at this time. SAHPRA is concerned that the use of the Sputnik-V vaccine in…an environment where the prevalence and high incidence of HIV may increase the risk of HIV infection in vaccinated men,” the statement said.
South Africa’s northern neighbor Zimbabwe was one of the first countries to approve the Sputnik V vaccine, despite also having a high incidence of HIV.
Russian mining company ALROSA donated 25,000 doses of the vaccine in June and pledged another 25,000 within months. The only other vaccines that have been administered in Zimbabwe are China’s Sinopharm and Sinovac, and India’s Covaxin.
The Gamaleya Institute, which developed Sputnik V, said “concerns about the safety of Ad5 vector vaccines in populations at risk of HIV infection are completely unfounded”, adding that SAHPRA would receive all information she needs.
More than 250 clinical studies and 75 international publications confirm the safety of human adenovirus vaccines and drugs, the institute added.
SAHPRA said it was consulting local and international scientific experts to make its decision and relevant safety data may still be submitted as the “ongoing review” of the vaccine remains open.
South Africa, which has bilateral agreements for two-dose vaccines from Pfizer and the single-shot vaccine from Johnson & Johnson, has now administered more than 20 million doses. About 14 million people have received at least one dose of the vaccine, or 35% of the adult population.