South African regulator rejects Russia's COVID-19 vaccine

The South African drug regulator has rejected the Russian-made coronavirus vaccine Sputnik V, citing some safety concerns the manufacturer wasn’t able to answer

JOHANNESBURG -- The South African drug regulator has rejected the Russian-made coronavirus vaccine Sputnik V, citing some safety concerns the manufacturer wasn't able to answer.

The South African Health Products Regulatory Authority, or SAHPRA, said in a statement Tuesday that the request for Sputnik V to be authorized could “not be approved at this time,” referring to past failed HIV vaccines that used a similar technology.

A late-stage study published in the journal Lancet last year in more than 20,000 participants found that Sputnik V was safe and about 91% effective in preventing people from becoming severely ill with COVID-19.

Sputnik V uses two types of harmless viruses known as adenoviruses to carry the spike protein into the body, which then primes the immune system to produce antibodies against COVID-19. SAHPRA said concerns have been raised about the safety of Adenovirus Type 5, which is used in one of the Sputnik V doses. The other dose contains Adenovirus Type 26, which is also used by Johnson & Johnson.