Source: Eyewitness News
The South African Health Products Regulatory Authority (SAHPRA) on Tuesday approved the Pfizer/BioNTech coronavirus vaccine for human use.
SAHPRA released a statement on its website on Tuesday afternoon, saying that the Section 21 application for the vaccine was approved. A Section 21 application is usually valid for six months and is used for emergency use access of a health product that is unregistered. AstraZeneca’s COVID-19 vaccine was granted Section 21 approval by SAHPRA in January.
This means that the vaccine can be distributed but will be conditional on its efficacy and safety, which will be continuously monitored.
SAHPRA is tasked with regulating all health products in the country and also oversees clinical trials.
South Africa has already ordered 20 million doses of the vaccine, which is yet to arrive. Its arrival date is still to be made clear.
The vaccine rollout to South Africans has not begun yet. The Johnson & Johnson vaccine currently being given to healthcare workers is part of the implementation study for that vaccine.