Sahpra: Sputnik V applicants must provide data showing vaccine's safety

The South African Health Products Regulatory Authority (Sahpra) announced on Monday that it would not be approving the use of Sputnik V due to safety concerns on the AD5 component of the vaccine among populations at risk for HIV infection.

FILE: A nurse shows the Sputnik V (Gam-COVID-Vac) vaccine against the coronavirus disease (COVID-19) at a clinic in Moscow on 5 December 2020, amid the ongoing coronavirus disease pandemic. Picture: AFP

JOHANNESBURG - The South African Health Products Regulatory Authority (Sahpra) said that it was ready to consider any new data in the application for use of the Sputnik V vaccine.

Sahpra announced on Monday that it would not be approving the use of Sputnik due to safety concerns on the AD5 component of the vaccine among populations at risk for HIV infection.

The regulator said that in 2007 when the AD5 component was used in HIV vaccine trials both in South Africa and America, they noticed a higher acquisition of HIV in men.

CEO Boitumelo Semete-Makokotlela said that having considered this, they asked those applying for the use of Sputnik to provide the relevant data, showing the safety of the vaccine.

"In our crew, the data was not available and as with many other vaccines, the data is being collected as the vaccines are being rolled out, so at the time of our question, they didn't have the data available to share with us."

She said that the applicants could still present this data for consideration.

Sahpra said that it had not received an application for the approval of the so-called Sputnik light, that did not contain the AD5 component.

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