Why China’s Sinovac vaccine is yet to be approved in SA

By Rudolph Nkgadima Time of article published Jun 11, 2021

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NATIONAL Department of Health director-general, Dr Sandile Buthelezi says they are awaiting documentation from WHO confirming the quality of the Sinovac vaccine before the process of authorising it can begin.

The World Health Organisation (WHO) recently approved the Sinovac vaccine for emergency use, which paves the way for countries worldwide to approve and import a vaccine for distribution quickly.

With South Africa also faced with a short supply of available vaccines, Cabinet has welcomed the validation of the Sinovac and says this will enable the South African Health Products Regulatory Authority (Sahpra) to expeditiously consider the application of Sinovac for emergency use in the country.

Buthelezi said the department also wants to diversify the country’s vaccine menu, which currently includes Johnson and Johnson (J&J) and Pfizer, but without the necessary required documentation, the process of authorisation cannot proceed.

“We are working closely though independent with Sahpra in terms of registering the vaccines for use in South Africa. Sahpra is awaiting a dossier that the WHO used and they haven't received it and we hope that as soon as they get it, they will use it for reliance testing. So that they could probably be able to authorise it and also check if it is actually efficacious against the Beta variant which is dominant in the country,” said Buthelezi.

According to Sahpra, almost all the vaccines used in the country are manufactured in other countries, and the regulatory body requires documentation that confirms the quality from the regulatory authority in the country of manufacture.

Through an arrangement called reliance, which allows confidential exchange of information, Sahpra has formal relationships with certain regulatory authorities that allow this to happen.

For vaccine approvals, this allows Sahpra to access reports produced by other regulatory agencies on inspections, testing and various other aspects of manufacturing and testing compliance.

Sahpra has been testing the vaccine for more than two months, after the body received an application from Sinovac on March 10, 2021.

The Sinovac jab has already been administered in 20 countries around the world.

Sahpra is also awaiting approval from the US Food and Drug Authority (FDA) to approve the use of of the J&J vaccine after the agency halted its production.

Until the FDA has shared these reports, Sahpra says it has insufficient information to approve specific batches of the J&J covid-19 vaccine.

However, the WHO said this week that South Africa does not need approval from the FDA before it can begin administering the J&J vaccine to citizens as it was on the emergency use list.

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