SA health products regulator, Sahpra close to finalising decision on Sinovac vaccine approval

The South African Health Products Regulatory Authority (Sahpra) will reveal whether the Coronavac vaccine developed by Sinovac will be approved for use in the coming days. CEO, Dr Boitumelo Semete-Makokotlela provided an update on how far the institution was with vaccine registrations and approvals on Thursday morning.

She said a decision about whether it has approved Sinovac’s vaccine for use in South Africa was “close to being finalised and will be communicated to the company within the coming days”.

Semete-Makokotlela said it usually took many months to authorise the use of medicines and vaccines but due to the pressure of the pandemic, they have fast-tracked the process of authorising vaccines to about 90 working days.

“While we have drastically reduced our usual time frames for the registration of Covid-19 vaccines, we have not cut back on the checks required to ensure that they are safe and effective. We will not compromise on the safety of South Africans and we will not endanger South African lives,” Semete-Makokotlela said.

She said the medicines’ approval process entailed a rigorous process of assessment, where all information provided by the applicant was carefully evaluated by experts in their respective fields. She also emphasised that Sahpra relied on scientifically tested and proven data to make its decisions and not political pressure, bias or expediency.

The EFF organised a march, with more than 2 000 people, to the Sahpra offices in Pretoria last Friday. The EFF is demanding the organisation speed up the approval of Russia’s Sputnik V vaccine and the Chinese Sinovac-manufactured Coronavac vaccine. EFF leader Julius Malema handed over a memorandum demanding a response from the organisation in seven days.

Semete-Makokotlela said that every application for registration of a Covid-19 vaccine was evaluated against the same standards of safety, quality and efficacy.

“Sahpra has held numerous engagements with the representatives of the two applicants for registration of this vaccine. To date, we have exchanged correspondence on several occasions regarding the data required for their application,” she said.

The Sputnik V application is being processed under a rolling review process, meaning that Sahpra is processing their application as it received the data. “This vaccine is also being evaluated under Section 21, which enables us to authorise it for emergency use,” Semete-Makokotlela said.

The organisation added that it took its responsibility in the frontline of the battle against Covid-19 very seriously and would apply the “most rigorous, globally-accepted checks and standards” to the registration of Covid vaccines to ensure health and safety of South Africans and save lives.

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