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South African regulators have not yet approved the Russian COVID-19 vaccine




Johannesburg, October 18 (Reuters)-South African drug regulators approve Russia’s Sputnik VCOVID-19 shot emergency use application on Monday due to safety concerns for people at risk of HIV Said not.

South Africa is one of the most HIV-infected countries in the world, and Sputnik V’s administration of adenovirus type 5 (Ad5) vector vaccines may increase the susceptibility of men to HIV. Some studies suggest that.

Viral vector vaccines, such as Sputnik V, use the modified virus as a vehicle or vector to convey genetic information that helps the body build immunity to future infections.

Regulatory agency SAHPRA sought data showing that Sputnik V is safe in high-HIV-positive environments, but said it did not receive sufficient information to establish this.

“SAHPRA has resolved that the Sputnik V … (urgent) application is not approved at this time. SAHPRA may increase the use of the Sputnik V vaccine in environments with high HIV prevalence and incidence. I’m concerned about having sex. Vaccinated men are at risk of getting HIV. “

“There is absolutely no basis for concern about the safety of Ad5 vector vaccines in populations at risk of HIV transmission,” said the Gamareya Institute, which developed Sputnik V, adding that SAHPRA will have all the information it needs.

The institute added that more than 250 clinical trials and 75 international publications have confirmed the safety of vaccines and medicines based on human adenovirus vectors.

SAHPRA said it had consulted with local and international scientific experts to reach that decision, and said that the vaccine’s “rolling review” remained public and could be submitted with relevant safety data. rice field.

South Africa has a bilateral transaction of double-dose Pfizer (PFE.N) And one shot Johnson & Johnson (JNJ.N) The vaccine is currently administered more than 20 million times. Approximately 14 million people have been vaccinated at least once, which is equivalent to 35% of the adult population.

Report by Alexander Winning of Johannesburg and Polina Nicolskaya of Moscow Edited by Tim Cocks and Giles Elgood

Our criteria: Thomson Reuters trusts the principles.





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