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Sputnik V Covid 19 vaccine rejected by SAHPRA for now

After consulting local and international scientific experts and after taking into consideration all the data available, the South African Health Products Regulatory Authority (SAHPRA) has decided not to approve Russia's Sputnik V Covid 19 vaccine.

Since the application on 23 February 2021, SAHPRA has been reviewing the data and has resolved to not approve the vaccine for use in South Africa.

The regulator said in a statement: "SAHPRA is concerned that use of the Sputnik V vaccine in South Africa, a setting of a high HIV prevalence and incidence, may increase the risk of vaccinated males acquiring HIV." It added that the rolling review of the vaccine remains open 'for submission of relevant safety data in support of the application.'

According to SAHPRA, two separate adenovirus- vectored constructs are combined by the Sputnik V vaccine (The two separate adenovirus vectored constructs rely on the Adenovirus type 5 and the Adenovirus type 26 to deliver the antigen).

There are concerns over the safety of Adenovirus type 5- vectored vaccines in populations at risk for HIV infections. SAHPRA has requested data from the applicant that demonstrates the safety of the vaccine in a setting of high HIV prevalence.


Content created and supplied by: Gkmedia (via Opera News )

Adenovirus HIV SAHPRA South African Health Products Regulatory Authority Sputnik V Covid


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