Medicine regulator will not succumb to political pressure or sacrifice safety, says Sahpra CEO

Covid-19 vaccines. File photo: Henk Kruger/African News Agency(ANA)

Covid-19 vaccines. File photo: Henk Kruger/African News Agency(ANA)

Published Jun 27, 2021


Cape Town – The SA Health Products Regulatory Authority (Sahpra) will not succumb to political pressure to approve Covid-19 vaccines because the safety of the public should not be compromised, CEO Dr Boitumelo Semete said.

“Sahpra cannot allow political pressure to cloud a clear science-based approach to approving health products where the safety of the public could be compromised,” Semete said.

“It will be a sad day in the country when the regulator is undermined or influenced by any party.”

She said Sahpra was an independent, science-based entity that followed “strict guidelines and processes when approving health products”.

On Friday, the Economic Freedom Fighters (EFF) took to the streets of Pretoria and marched to Sahpra offices demanding the organisation speed up the approval of Russia’s Sputnik V vaccine and the Chinese Sinovac manufactured Coronavac vaccine.

The party has for a while advocated for the government to procure the two vaccines. In February, Sahpra indicated it was reviewing applications linked to the Sinovac and Sputnik vaccines.

The EFF handed over a memorandum to Semete, which will be responded to. The party gave the regulator seven days to respond the their vaccine demands.

Semete said that as a regulator, Sahpra was concerned with the “safety, quality and efficacy” of health products.

“These essential requirements are consistently applied to all Covid-19 vaccines and therapeutics that Sahpra has considered for use in the country.”

Semete said that the regulator did not favour any applicant.

“Sahpra, as part of its mandate, focuses on the safety and well-being of the public and no vaccine can be made available until it meets these regulatory requirements,” she said.

“Furthermore, Sahpra must take into account the local epidemiology, and specifically which SARS-CoV-2 variants of concern are circulating in the country,” she said.

“In essence, the EFF wants Sahpra to approve vaccines without adherence to the critical components of safety, quality and efficacy. This could compromise public safety.”

On Saturday, Acting Health Minister Mmamoloko Kubayi-Ngubane briefed the media on the new Delta variant and the surge in new infections.

Kubayi-Ngubane warned that the new delta variant was more transmissible and was spreading faster as Covid-19 infections continued to rise.

Health experts Professor Tulio de Oliveira and Dr Richard Lessells also said the delta variant, which was first detected in India in October last year, was spreading faster.

President Cyril Ramaphosa is expected to address the nation on Sunday night at 8pm on new measures to deal with the rising infections of Covid-19 in the country.

Ramaphosa’s address will come after the meeting of the National Joint Operational and Intelligence Structure (Natjoints).


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