SAHPRA says it will not be pressured to approve vaccines not suitable for use in SA

A medical worker holds a vial with Sputnik V (Gam-COVID-Vac) vaccine. The South African Health Products Regulatory Authority (Sahpra) said on Thursday it will carry out due diligence in the approval process for vaccines, and refuses to be pressured into approving those not suitable for use in SA.
A medical worker holds a vial with Sputnik V (Gam-COVID-Vac) vaccine. The South African Health Products Regulatory Authority (Sahpra) said on Thursday it will carry out due diligence in the approval process for vaccines, and refuses to be pressured into approving those not suitable for use in SA.
Image: Tatyana Makeyeva

The SA Health Products Regulatory Authority (Sahpra) says it will not be pressured into approving Covid-19 vaccines that do not meet the regulatory requirements and are inappropriate for use in SA.

CEO Dr Boitumelo Semete-Makokotlela was speaking on Thursday during a webinar about the evaluations of vaccines.

Her remarks come as the EFF gears up for a mass protest at the authority's Tshwane offices, where it will demand the approval of more vaccines to speed up the rollout process in phase 2 of inoculations.

Semete-Makokotlela said the assessment process does not only include evaluating local data. 

“When we make a decision, we don’t only consider data generated from SA. We are working with experts - international experts - and we continuously review the emerging data around these vaccines,” she said. 

Asked for a response regarding the EFF march, she said the red berets were constitutionally within their rights to march. 

“We just hope and urge the [marchers] to comply with the Covid-19 safety protocols of wearing masks and social distancing. Gauteng has high [infection] numbers and we really need to make sure that, through non-pharmaceutical interventions, these are managed.”

Contrary to claims made by the EFF that the regulator is not doing enough to approve more vaccines, Semete-Makokotlela said Sahpra is evaluating the Sputnik V jab, among others. 

“We are evaluating the Sinovac vaccine. We are also evaluating the Sputnik vaccine. This week, we’ve received an application for Sinopharm. We are really quite busy as an organisation and the only thing we’re going to concern ourselves with is science.

“While the authority understands that this is a pandemic and understands that delays have been experienced, it is important to indicate that the safety of the public is paramount and needs to be safeguarded.   

“Wherever we are of the view that the regulatory requirements are not met, we will not issue an authorisation.”

Julius Malema is expected to lead EFF supporters who will take part in the “march to save lives” on Friday.

He has on numerous occasions criticised the regulator for its “refusal” to approve more vaccines, other than the Johnson & Johnson and Pfizer jabs.

The red berets want Sputnik V and Sinopharm vaccines administered in SA. Last week, Malema threatened a “sleep-in” outside the home of the CEO if the regulator failed to heed their demands. 

“This Friday, we are at Sahpra because we want vaccines. Failure to respond in seven days, you must find the address of the home of the CEO of Sahpra. It is personal like that. There will be a sleep-in at his house until vaccines are provided by this government.” 

Mass gatherings are prohibited under level 3 regulations, as the government seeks to minimise the spread of Covid-19, but Malema stressed the importance of saving lives over safety and adhering to Covid-19 regulations.

“Our generation will be saluted by the next generation, that we saved lives when it was not fashionable to do so,” he said.  

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