TGA Provisional Approval of Pfizer-BioNTech COVID-19 vaccine to include 12-15 years age group

The Therapeutic Goods Administration (TGA) has provisionally approved the use of the Pfizer BNT162b2 COVID-19 vaccine (COMIRNATY) in individuals 12 years and older. Previously, the Pfizer COVID-19 vaccine was provisionally approved for use in individuals 16 years or older.

Provisional approval for use in the 12-15 years age group has been made following careful evaluation of the available data supporting safety and efficacy, including clinical studies with adolescents 12 to 15 years of age. Use in this age group was supported by the independent expert Advisory Committee on Vaccines.

Further details of the data supporting this approval and TGA's evaluation are included in the Product Information (PI) (pdf,454kb) and the Australian Public Assessment Report (AusPAR).