IDXChannel – Drug regulator south Africa (South Africa) has rejected the artificial corona vaccine Russia, Sputnik V. This is reasonable because there are several safety issues that cannot be answered by the manufacturer.
South Africa’s Health Products Regulatory Authority (SAHPRA) said in a statement that Sputnik V’s request for approval “could not be approved at this time,” referring to past failed HIV vaccines that used similar technology. However, the regulator added that the review process is ongoing and is still open to receiving further safety data from the Russian manufacturer.
As Africanews reported on Thursday (10/21/2021), 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 seriously ill with COVID-19.
Sputnik V uses two types of harmless viruses, known as adenoviruses to carry spike proteins into the body, which then strengthen the immune system to produce antibodies against COVID-19.
“Concerns have been raised about the safety of Adenovirus Type 5, which was used in one dose of Sputnik V. The other dose contained Adenovirus Type 26, which was also used by Johnson & Johnson,” the SAHPRA statement said.
South African officials pointed to two research studies that failed to test an HIV vaccine also using Adenovirus Type 5, which found vaccinated men had a higher risk of HIV infection. Regulators said they had asked Russia’s maker of Sputnik V to provide data proving the vaccine’s safety in a country with high HIV rates. However, manufacturers were unable to meet the demand.
In a statement, Gamaleya Center, the manufacturer of Sputnik V, called concerns about the vaccine vector “completely unfounded. “Speculation about an association between Adenovirus Type 5 and HIV transmission in high-risk populations is based on small-scale inconclusive studies among volunteers with risk behaviors. which is very possible,” said the Gamaleya Center statement.
Julian Tang, a virologist at the University of Leicester, UK, is baffled by South Africa’s decision to reject Sputnik V. “This is a strange relationship to make. Not the vector that causes HIV. So you can’t just blame him,” Tang said.