Sahpra says no to Sputnik V Covid-19 vaccine - for now

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  • Sahpra says Sputnik V Covid-19 vaccine not approved - but rolling review continues.
  • Regulator concerned about data related to vaccine in high-HIV prevalence settings.
  • Vaccine has not yet received Emergency Use Listing by the WHO.


The South African Health Products Regulatory Authority (Sahpra) on Monday said that after consideration, Russia's Sputnik V Covid-19 vaccine has not been approved for use in South Africa.

The regulator had been engaged in rolling review of the data for the Sputnik V vaccine since the initial application was submitted on 23 February 2021.

But after consultation with local and international scientific experts, and consideration of the available data, Sahpra said it resolved to not approve the vaccine.

"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," the regulator said in the statement.

However, it said that the rolling review of the vaccine remains open "for submission of relevant safety data in support of the application".

Background

The Sputnik V vaccine, Sahpra said, combines two separate adenovirus-vectored constructs, one relying on the Adenovirus Type 26 (Ad26) and the other on Adenovirus Type 5 (Ad5), as the delivery vehicles for the antigen.

“Concerns have been raised about the safety of Ad5-vectored vaccines in populations at risk for HIV infection.

“One of the challenges faced by such vaccines is the presence of pre-existing Ad-specific neutralising antibodies (NAbs) in the general population,” it said.

After reviewing study and trial research, Sahpra says it requested the applicant to provide data demonstrating the safety of the Sputnik V vaccine in settings of high HIV prevalence and incidence.

“The applicant was not able to adequately address Sahpra’s request.”

Sputnik V has also not yet received Emergency Use Listing by the World Health Organization.

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