SAHPRA approves Section 21 use for Pfizer’s Covid-19 vaccine

In a step seen as a boost to the country's inoculation project, the regulator gives conditional green light to Pfizer/BioNTech vaccine.

The country’s medicines regulatory, the South African Health Products Authority, announced on Tuesday that it has granted a Section 21 emergency use authorization for the Covid-19 vaccine manufactured by Pfizer and BioNTech. “This approval is subject to conducting a post Section 21 authorisation efficacy and safety surveillance of Comirnaty vaccine in South Africa,” said SAHPRA in its statement on Tuesday. A Section 21 authorization is granted to allow for access to medicines on an exceptional basis, in instances whereby conventional therapies have either been ruled out, have failed or are not available as marketed products.

South Africa has ordered 20 million doses of the vaccine and is expected to accept delivery of about 600,000 doses of the vaccine before the end of March, according to the health minister, Dr Zweli Mkhize. The two-shot vaccine manufactured by Pfizer and BioNTech was shown to be 95% and its efficacy was proven to be consistent across age, gender, race and ethnicity demographics. With the global pharma giant looking to manufacture up to 1.3 billion doses of the vaccine, South Africa joins a growing list of countries looking to secure sufficient supplies to vaccine their populations.