Sinovac vaccine: ‘A turning point for our country’ says Kubayi-Ngubane

Acting Health Minister, Mmamoloko Kubayi-Ngubane has described the approval of the Sinovac vaccine for use in South Africa as a turning point and much needed relief for the country’s lagging vaccination rollout programme.

The South African Health Products Regulatory Authority (SAHPRA) made the announcement on Saturday, 3 July and the CoronaVac COVID-19 vaccine is manufactured by Sinovac Life Science.

The Acting Health Minister said the authorisation with conditions, is based on the safety, quality and efficacy data submitted by the vaccine manufacturer to SAHPRA between 22 March 2021 and 22 June 2021.

“On behalf of the Department, I would like to express gratitude to our regulatory authority for their sense of urgency, which included reducing turnaround time to process applications for registration of medical products, COVID-19 vaccine in particular – without compromising their strict guidelines to ensure the safety of our people.

“Accordingly, SAHPRA has indicated that while it considered the submitted data acceptable at this point, the authorisation is subject to a number of conditions including submission by the manufacturer of the final results of ongoing clinical studies. The regulator also took account of the World Health Organization (WHO) Emergency Use Listing (EUL) report on this vaccine.

“Amongst the conditions, the manufacturer will provide any information that comes into its possession relating to risk conditions of use and efficacy of the product.”

The Health Department also said that more information about the Sinovac vaccine, including the level of safety and efficacy against the current dominant Delta variant in South Africa will be made public at a later stage, once a formal report has been received from SAHPRA.

The Economic Freedom Fighters has taken credit for the approval following their #MarchToSaveLives to SAHPRA offices in Pretoria.

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