Monday, 05 July 2021

Pretoria: Acting Health Minister Mamoloko Kubayi has described the South African Health Products Regulatory Authority’s (SAHPRA) use approval of the Sinovac COVID-19 vaccine in the country as a turning point and much-needed relief for South Africa’s vaccination rollout programme.

SAHPRA at the weekend announced it had authorised the jab, albeit with conditions. This was based on the safety, quality and efficacy data submitted by the vaccine manufacturer to SAHPRA between 22 March 2021 and 22 June 2021.

The authority 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,” said the Ministry.

The approval comes at a time when the government is implementing an expanded and multipronged vaccination programme to reach as many people as possible, while the infection numbers continue to increase at an alarming rate. This would enable government to initiate procurement processes to secure more vaccines.

“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.

“It is an undeniable fact that SAHPRA plays a key role in the country’s response to this pandemic by ensuring that safe and efficacious vaccines are approved for use in the country,” said Kubayi.

The Ministry said further information about Sinovac, including the level of safety and efficacy against the current dominant Delta variant in South Africa, would be made public at a later stage, once a formal report has been received from SAHPRA.