SAHPRA Speeds Up Its Vaccination Approval Deadlines

South Africa's Health Products Regulatory Authority, also known as SAHPRA, says it is currently in the process of speeding up it's approval of the vaccines that are currently under review.


South Africa's Health Products Regulatory Authority (SAHPRA) says it is currently in the process of finalizing its approval of the Corona-Vac vaccine developed by Sinovac vaccine among other applicants. 

CEO Dr Boitumelo, Semete-Makokotlela, provided an update on how far the institution was with vaccine registrations and approvals on Thursday morning. She said that a decision on the Sinovac vaccines that is currently under review will be made in the coming days. 

Semete-Makokotlela also said that they have fast-tracked the process of authorising vaccines to about 90 working days.

Right in the beginning, we said we are expediting everything that pertains to Covid, so instead of taking twenty months like we typically do with vaccines we said we've got good quality submission data so it should take something like 90 working days which is a little over 3 months. 

The Sinovac, Sinopharm and Spukni V vaccines are the ones that are currently undergoing evaluation.

So we have three others that we are currently evaluating that is the Sinovac Vaccine, the Sputnik V vaccine and the Sinopharm vaccine. So even though it's three, we might have multiple applicants. Sinopharm we received last week so we are busy with the early review of that.

With Sputnik V, they have applied for emergency use under a running review and there was critical data that was required to be able to proceed with the emergency review of that. They've also received a lot of the data that they asked for.

"Sinovac, we have had numerous engagements with the applicant, also similarly we have issued queries they have responded and we hope they'll be a resolution on that in the next coming days," she said 

On the subject of side effects, Semete-Makokotlela says SAHPRA has a mechanism in place that allows the regulator to withdraw the use of that particular product, which is also done in consultation with the applicant based on strong causality and scientific data. 

Additionally, Business Day reported that the U.S will donate one million doses of the Pfizer vaccine to South Africa and it is expected to arrive within the next few weeks

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