Sahpra says it will only be ‘swayed’ by science not political pressure.

By Lehlohonolo Lehana.

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

“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.

Meanwhile an investment company owned by medical doctors, Liseko Investments, has threatened to take legal action against the EFF’s Fana Mokoena for comments he made about the company on Twitter.

In a tweet shared on Friday, Mokoena shared names accompanied by pictures of SA Health Products Regulatory Authority (Sahpra) chair Prof Helen Rees and her husband, Dr Fazel Randera, who he said was a shareholder at Liseko investments. Mokoena also stated Liseko is a partner at Aspen Pharmacare which produces the J&J vaccine.

His comments were made on the same day hundreds of his party’s supporters and party leader Julius Malema gathered outside the offices of Sahpra for their “march to save lives” and demand approval of the Chinese and Russian Covid-19 vaccines for use in SA.

In a statement, Liseko Investments said the comments were defamatory and malicious.

“We take deep exception to the scurrilous libel directed at Liseko and its directors and will pursue such legal remedies as we deem appropriate,” the company said in a statement.

The company said it holds no direct or indirect interest in the business, operations or strategy of Aspen Pharmacare and “averments to the contrary are false and libellous”.

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