Sahpra CEO says two more Covid-19 vaccine applications are under review

Two more Covid-19 vaccines are now under review by the SA Health Products Regulatory Authority (Sahpra).

Speaking on SAfm on Friday, CEO of the regulatory authority Dr Boitumelo Semete-Makokotlela said they were reviewing the Sputnik and Sinovac vaccines.

She did not indicate when they would make a decision on whether to approve the two vaccines for use in SA.

“The time it takes us to approve or not depends on the quality of data we receive from the applicants, and the key question is about the availability of data around efficacy on the 501Y.V2 variant. Even if it is lab data, we would still be able to use it,” she said.

Semete-Makokotlela said the two reviews were being done through their emergency evaluation procedure, used to approve the Pfizer and Johnson & Johnson vaccines.

She said all hands were on deck to ensure a speedy review of the vaccines, but emphasised they had to strike a balance between being responsive to the pandemic and making decisions based on scientific evidence.

Regarding the Sinopharm vaccine from China used by other African countries like Zimbabwe, Semete-Makokotlela said the regulator had not received an application from the manufacturer.

She said they did engage with the manufacturer during pre-submission meetings. They had told them what the regulator’s requirements would be and had not heard from them since.

“There is very little we can do as they haven’t submitted in the country,” she said.

As SA prepares to roll out vaccines to more groups of people, the Sahpra CEO said the current vaccine approvals would be applicable to all groups of people meant to receive them, be it the elderly or those living with comorbidities. The only exclusion remained for pregnant women as there was little data available on the efficacy and risks involved.

Semete-Makokotlela said there was an application for a clinical trial to be conducted on children under 18 years.


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