Pfizer Vaccine Approved By SAHPRA



Covid-19 vaccine

The South African Health Products Regulatory Authority (SAHPRA) has approved for emergency use of the Pfizer vaccine. 

In a statement released on 16 March 2021, SAHPRA said: 

"SAHPRA has approved the Section 21 application for the Pfizer/Biontech Comirnaty Vaccine."

This section 21 application is aimed at providing access to safe and effective medicine. It is usually valid for a period of 6 months, to support the use of medicine that is unregistered. 

"This approval is subject to conducting a post Section 21 authorisation efficacy and safety surveillance of Comirnaty vaccine in South Africa."

“This must always have regard to the safety, efficacy and quality of medicines accessed through Section 21 which are set out in Regulation 29.

SAHPRA has processes to ensure that medicines used in South Africa meet a particular standard. 

There are three pillars that SAHPRA uses to ensure that all medicines are safe to use. 

• Safety

• Efficacy

• Quality

The government has ordered 20 million Pfizer and BioNtech vaccines that are scheduled to arrive at the end of next month. 

"We have also secured 20 million doses from Pfizer, which will be delivered from the second quarter. Additionally, we have secured 12 million vaccine doses from the COVAX facility and are in the process of finalising our dose allocation from the African Union.

"We are in constant contact with various other vaccine manufacturers to ensure that we have the necessary quantities of vaccines when we need them." said President Cyril Ramaphosa. 


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