Covid-19 vaccines: CoronaVac application at advanced stage, Sputnik V still under review - Sahpra

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  • The CoronaVac and Sputnik V Covid-19 vaccine applications are under review by Sahpra
  • In an updated statement, the regulatory body's CEO said that the CoronaVac application is at a 'very advanced stage'
  • Both jabs use well-known vaccine technology

The South African Health Products Regulatory Authority (Sahpra) has received applications for CoronaVac, as well as Sputnik V, Dr Boitumelo Semete-Makokotlela, CEO of Sahpra said in an updated statement on the vaccine approvals on Monday.  

“The evaluation of the CoronaVac application is at a very advanced stage. Furthermore, reports recently made available by the [World Health Organization] that articulate the basis for the Emergency Use Listing are being considered,” she said.

According to the statement, the Sputnik V application is a rolling review, which means data is being continuously submitted for checking by Sahpra as it becomes available.

The rolling review process was introduced by the regulatory body in an effort to respond to the pandemic, the release explained.

In May, Sahpra told Health24 that it had requested further information from the supplier of the Russian vaccine.

“Whilst reviews can commence earlier with a rolling submission, it is important to note that some very important efficacy, quality and safety information is sometimes outstanding and would require review for consideration of such products for public use,” Semete-Makokotlela said in the latest release.

CoronaVac and Sputnik V technology

The two-dose CoronaVac vaccine is developed by the Beijing based pharmaceutical firm Sinovac. It uses a more traditional method of vaccine technology that is successfully used in other well known vaccines such as rabies, Associate Professor Luo Dahai of the Nanyang Technological University told the BBC

Sputnik V, also a two-dose vaccine, is developed by the Russian medical-research institution, Gamaleya Research Institute. It also uses a well-established technology and works in a similar way to the Johnson & Johnson (J&J) vaccine.  

Both vaccines were tested in clinical trials. A study published in The Lancet revealed that Sputnik V was 92% effective at preventing Covid-related hospitalisation and death, while reporting by Business Insider SA noted that CoronaVac’s efficacy was just above 50%. 

No applications by Moderna, Sinopharm

The Covid vaccines developed by Pfizer-BioNTech and J&J have already been approved by the regulatory body and are currently being rolled out in South Africa.

Both Moderna and Sinopharm, which have a WHO Emergency Use Listing, have not submitted any applications for the use of their vaccines in the country, Semete-Makokotlela said.

“Of concern is the prevalence of variants of concern such as the beta variant in South Africa. This requires that Sahpra ensure efficacy against such variants and hence information on studies supporting efficacy would be expected to be provided by the applicant,” she added.

*For more Covid-19 research, science and news, click here. You can also sign up for our Daily Dose newsletter here.

READ | The EVDS will schedule your appointments for the Pfizer Covid-19 vaccine 6 weeks apart. Here’s why

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

READ | Sputnik V and Sinopharm vaccines explainer: Everything you need to know

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