Although Pfizer is the only one approved now, others may follow as SAHPRA receives more data.
On 10 September, the South African Health Products Authority (SAHPRA) announced that the use of the Pfizer Comirnaty vaccine had been approved for use in children 12 years and older. During a regular Western Cape digital press conference to educate citizens about the health platform and immunization program across the province, SAHPRA’s Chief Executive, Dr. Boitumelo Semete-Makokotlela clarified why children 12 and older will only receive the Pfizer jab for now. Semete-Makokotlela explained that part of their role at SAHPRA is to assess preclinical data to ensure that the vaccine trial meets all regulatory requirements for vaccines, and to assess clinical trials in terms of data, safety and to provide evidence of the vaccine’s ability to prevent COVID-19.
The regulator considers the data presented to them when selecting which vaccines, the newly approved age cohort can take. “For us again, if we don’t receive data indicating that the vaccine is effective and safe in this cohort, we cannot go out and solicit,” added the CEO. “So far, the vaccine that has been licensed across the world – and there are other (places) where studies are being done – is largely the Pfizer vaccine,” Semete-Makokotlela said. Up until now the regulator has only received one application request from Pfizer for use in this age cohort. The South African Pediatric Association (SAPA) applauded the approval, with SAPA President Professor Mignon McCulloch stating that parents should have no concerns. The vaccine roll-out date for this age group has yet to be announced.