COVID-19: South Africa rejects Russian Sputnik V vaccine

South Africa’s drug regulatory body refused to authorize the Russian-made coronavirus vaccine Sputnik V, citing some safety concerns that the manufacturer was not able to answer.

The South African Health Products Regulatory Authority (SAHPRA) said in a statement released Tuesday that Sputnik V’s application for authorization “could not be approved at this time,” referring to failed HIV vaccines. who used similar technology; however, the agency added that its review process continues and remains open to receiving additional safety data from the Russian manufacturer.

An advanced stage study with more than 20,000 participants and published last year in the Lancet. found Sputnik V to be safe and about 91% effective in preventing people from getting severe COVID-19. Sputnik V uses two types of harmless viruses known as adenoviruses to transport the spike protein to the body, priming the immune system to produce antibodies against COVID-19.

SAHPRA alleged that concerns have been raised about the safety of adenovirus type 5, which is used in one of the doses of Sputnik V. The other dose of the Russian vaccine contains adenovirus type 26, which is also used in the vaccine of Johnson & Johnson.

South African authorities pointed to two failed research studies that tested an HIV vaccine that also used adenovirus type 5 and found that vaccinated men were at increased risk of becoming infected with HIV. Regulatory authorities noted that they asked the Russian manufacturers of Sputnik V for additional information demonstrating the safety of the vaccine in a country with high HIV rates, but “the applicant did not respond to the request adequately.”

In a statement, the Gamaleya Center, maker of Sputnik V, described concerns about the vaccine vector as “completely unfounded.” He noted that speculation about the link between adenovirus type 5 and HIV transmission in high-risk populations was based on “inconclusive small-scale studies among volunteers with likely high-risk behavior. He stressed that the same vector was used in the vaccine. china CanSino, which has been applied on a large scale in China.

Dr Julian Tang, a virologist at the University of Leicester in Great Britain, was surprised by South Africa’s decision to reject Sputnik V. “It’s a strange connection,” he said, explaining that while concerns have been raised about the use Of a particular virus vector in Sputnik V, much remains to be known. “It’s not the vector that caused HIV, so you can’t blame that for that,” Tang explained.

The vaccine manufactured by AstraZeneca uses a chimpanzee-related adenovirus; this vaccine and that of Johnson & Johnson are licensed for use in South Africa.

Given the enormous reluctance to get vaccinated in Russia, authorities have had trouble convincing people to get vaccinated, and the immunization rate in the country remains very low, around 32%, despite the availability of the Sputnik V vaccine.
Currently, the World Health Organization and the European Medicines Agency are considering giving their authorization to Sputnik V, which has already received the green light in more than 70 countries. To date, no major safety problems have been identified in the Russian vaccine.



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