South African drug regulator cites safety concerns in rejecting Russia’s vaccine

South Africa’s health regulators released a statement Monday announcing it was rejecting the Russian-made Sputnik V vaccine. 

The statement from the South African Health Products Regulatory Authority (SAHPRA) said the vaccine was not approved because of the Adenovirus Type 5 virus used in the vaccine. 

The statement says the same virus was used in an HIV vaccine that was later discovered to increase the risk of HIV in men. 

“SAHPRA therefore requested the applicant to provide data demonstrating the safety of the Sputnik V vaccine in settings of high HIV prevalence and incidence,” the regulator said. “The applicant was not able to adequately address SAHPRA’s request.”

Julian Tang, a virologist at Britain’s University of Leicester, told The Associated Press it was odd for the agency to reject the vaccine because of the Adenovirus Type 5 virus.

Tang said there have been concerns raised about the vaccine but that there is not much evidence to support the agency’s conclusion. 

“It’s a strange connection to make,” he said. “It’s not the vector that caused HIV so you can’t just blame it on that.”

The agency said it would be open to more submissions regarding the safety of the Russian vaccine.

“SAHPRA is concerned that use of the Sputnik V vaccine in South African, a setting of a high HIV prevalence and incidence, may increase the risk of vaccinated males acquiring HIV,” it added. 

South Africa has the largest HIV outbreak in the world, with more than 7 million people estimated to be living with the virus — about 20 percent of the world’s entire HIV-positive population. 

Russia made Sputnik V the first COVID-19 vaccine to be approved for human use, and it has been found to be a safe coronavirus vaccine. Russia said earlier this month that it expects World Health Organization authorization soon. 

The rejection comes as Russia experiences its highest death count from COVID-19 since the pandemic started. It is struggling to fulfill Sputnik V vaccine orders, with millions waiting for their doses. 

The Hill has reached out to the Gamaleya Institute, which makes the Russian vaccine, for comment.