Covid-19: Sahpra waiting for Sputnik V vaccine manufacturer to respond as part of approval process

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  • Sahpra is waiting for additional information on the Sputnik V vaccine from its manufacturer
  • The Russian manufacturer submitted its application in February
  • Sahpra says that the Chinese vaccine that was submitted in March is still under review

The South African Health Products Regulatory Authority (Sahpra) says it’s awaiting a response from Sputnik V Covid-19 as part of the body’s approval process.

The Sputnik V vaccine was developed by the Gamaleya National Center of Epidemiology and Microbiology in Russia. The manufacturing company submitted its application to Sahpra in February this year.

Sahpra tells Health24 that it has finished its review of the Russian vaccine but requested further information from the supplier. 

“Sahpra has conducted reviews or evaluation and is waiting for the manufacturer/applicant to provide relevant information for the purpose of assuring the public of safe and effective medicinal products,” said Sahpra spokesperson Yuven Gounden.

Two vaccines being considered

As part of South Africa's vaccination programme, the national health department said that it had considered Sputnik V as well as CoronaVac produced by Chinese-based biopharmaceutical company Sinovac.

Gounden says that the Sinovac vaccine is still under review. The Chinese manufacturer submitted its application to the body in March.

“The Sinovac vaccine is also in the assessment process. Once all requirements are met, this submission may be approved,” he told Health24.

How well do these vaccines work against Covid-19?

In a study published in The Lancet, the Sputnik V vaccines was found to be 92% effective after two doses in a trial of 20 000 people, while Business Insider SA reports that the Sinovac vaccine's efficacy is just above  50%. Both vaccines' efficacy is, however, lower against the SARS-CoV-2 variant currently dominant in South Africa.

*For more Covid-19 research, science and news, click here.

READ| For men, low testosterone could mean a higher risk of severe Covid-19

READ| Covid-19 vaccines: Four things you need to know

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