The South African regulator approved Pfizer’s application to amend their dosing schedule in children and adults.
Today, the South African Health Products Regulatory Authority (SAHPRA) approved the use of Pfizer’s COVID-19 vaccine as a third booster shot. The shot is authorized for use in adults as well as children 12 and older, and the approval comes as the country prepares for the impending fourth wave. SAHPRA had originally approved Comirnaty, Pfizer’s COVID-19 vaccine earlier this year and on 17 November, the regulator received an application for the amendment of the COVID-19 vaccine’s dosing schedule. The amended schedule allows for an additional, optional third dose. The booster shot has been approved for administration at least six months after the second dose for people 18 years and older and at least 28 days after the second dose for people 12 years and older who are severely immunocompromised.
South African health minister, Joe Phaahla had stated in October that the country would start vaccinating people aged between 12 and 17 years using Pfizer’s Comirnaty. The vaccine would be administered as a single dose, rather than the two doses ordinarily administered in adults. The reduction in dose was due to concerns that the vaccine may adversely affect the heart. In a statement SAHPRA said, “The data provided only dealt with the situation of homologous boosting, where the third dose is of the same vaccine as the initial course (in this case, two doses).” The regulator noted that it was aware of the eager interest in the safety and efficacy related to heterologous boosting regimes, known as “mix-and-match” approaches and welcomes submissions of data that supports the approach.