Members of the EFF chant during their march to the offices of the South African Health Products Regulatory Authority to demand that the organisation speed up the approval of other vaccines. Picture: Thobile Mathonsi African News/Agency (ANA)
Members of the EFF chant during their march to the offices of the South African Health Products Regulatory Authority to demand that the organisation speed up the approval of other vaccines. Picture: Thobile Mathonsi African News/Agency (ANA)

Plaudits for EFF after marching for vaccine as health regulator approves CoronaVac

By James Mahlokwane Time of article published Jul 5, 2021

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Pretoria - #ThankyouEFF began trending on Twitter on Saturday following news that the South African Health Products Regulatory Authority (Sahpra) had approved a vaccine manufactured by Chinese pharmaceutical company Sinovac Life Sciences Co for use against Covid-19 in the country.

This comes shortly after the party leadership and its members flocked to Sahpra offices in Pretoria last month, demanding that the regulator approve the vaccine.

The party said that if it was not for its efforts, people would still not have the vaccine approved due to “narrow and unscientific imperialism in terms of vaccine procurement”.

They called for the immediate roll-out of the vaccine, and called on the government to abandon the “fruitless” policy of having to register for vaccines and allow people to be vaccinated on site on producing identification.

According to the EFF, the decision to approve the use of CoronaVac meant the collusion of Sahpra with Aspen and global pharmaceutical companies, at the behest of compromised individuals such as Helen Rees, whose husband is a shareholder at Aspen, had been decisively undermined.

However, Sahpra has stood firm that it will only be swayed by science in its dealings with the sensitive processes of approving and disapproving vaccines to be used in South Africa.

Sahpra chief executive Dr Boitumelo Semete-Makokotlela said the health regulator was considering an application from Sinopharm from China at the time of the protest, and would make its decision.

Sahpra subsequently explained that the recent authorisation was done in terms of Section 21 of the Medicines and Related Substance Act 101 of 1965, a mechanism in the Medicines Act that enables emergency use access and also enables Sahpra to authorise a medicines subject to certain conditions.

“CoronaVac is indicated for active immunisation in individuals aged between 18 and 59 years against Covid-19,” Semete-Makokotlela said.

“The vaccine is administered as two doses of 0.5ml, given intramuscularly, with the second dose administered between 14 and 28 days after the first dose.

“This authorisation is based on the safety, quality and efficacy data submitted by Curanto Pharma to Sahpra between March 22 and June 22 this year. Although the data submitted are considered acceptable at this point, the authorisation is subject to a number of conditions,” she said.

She added that the applicant was required to submit the final results of ongoing clinical studies. In addition, the conditions of the approval required the submission of periodic safety updates.

Moreover, Curanto Pharma, which imported the vaccine, must provide any data or information generated or which otherwise comes into their possession, which is relevant to the risk benefit profile of the product and/ or is relevant to the conditions of use.

Pretoria News

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