The SA Health Products Regulatory Authority (Sahpra) has revealed that the process of reviewing the CoronaVac vaccine, which is developed by Sinovac Biotech of Beijing, China, is at an advanced stage and will be approved for use in the coming days.
The organisation held a media briefing on Thursday, following a protest by the EFF at its head offices in Pretoria a week ago, demanding the approval of the CoronaVac and Sputnik V Covid-19 vaccines.
CEO Dr Boitumelo Semete-Makokotlela said that, in addition to CoronaVac, they were currently reviewing applications for one of the Sinopharm vaccines and for the Sputnik V vaccine, manufactured by the Gamaleya Research Institute in Moscow, Russia.
“The medicines’ approval entails a rigorous process of assessment, in which all information provided by the applicant is carefully evaluated by experts in their respective fields,” she said.
“The Sputnik V application is under a rolling review process, meaning that we are processing their application as we receive the data. This vaccine is also being evaluated under Section 21, which enables us to authorise it for emergency use. 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,” said Semete-Makokotlela
Sahpra announced that, even though they had reduced assessment time frames to register new Covid-19 vaccines from 20 months to 90 days, they had not compromised on the safety issues.
“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 the safety of South Africans and we will not endanger South African lives,” she said.
The organisation also revealed that vaccines manufactured by Moderna or Novavax were not under review, as Sahpra was not able to review the vaccines without an application from a locally-licensed applicant.
“We, like the rest of South Africa, may be aware of other vaccines that are being used in other countries but, unless we receive an application for its approval, we cannot register it,” Semete-Makokotlela said.
Over a week ago, EFF leader Julius Malema led a march to the Sahpra offices in Pretoria, demanding approval and authorisation of Russia’s Sputnik and the Chinese CoronaVac vaccines. The party accused Sahpra of dragging its feet in approving the vaccines that are in high demand.
But Semete-Makokotlela dismissed these allegations, stating that her organisation was acting in a responsible manner.
“As a regulator with integrity, which places the interests of the country it serves and its people at the forefront of its decision-making, Sahpra is committed to acting responsibly and in accordance with its mandate at all times. Sahpra strives to be responsive in this time of crisis, ensuring that health products are timeously and appropriately assessed and authorised. We welcome any endeavour by civil society and political parties which can constructively assist Sahpra in meeting its mandate. We will authorise Covid-19 vaccines that meet the necessary standards of safety, quality and efficacy as soon as possible,” Semete-Makokotlela said.