Provisional determination granted to Pfizer in relation to COVID 19 vaccine, COMIRNATY - for use in individuals 12 years of age and older

On 11 May 2021, the Therapeutic Goods Administration (TGA), part of the Department of Health, granted a provisional determination to Pfizer Australia Pty Ltd in relation to its COVID-19 Vaccine, COMIRNATY.

Currently, COMIRNATY is provisionally approved for use in adults 16 years of age or older. The granting of this determination means that Pfizer is now eligible to apply to vary its provisional registration for the vaccine for use in individuals 12 years and age or older.

This provisional determination is the first step in the process and does not mean that an application for variation has been made - or that any such variation will be approved.

In making its decision to grant Pfizer a provisional determination for use in individuals 12 years of age and older, the TGA considered all eligibility criteria, including factors such as the evidence of a plan to submit comprehensive clinical data in relation to use in this age group - and the seriousness of the current COVID-19 pandemic.

Further information on the provisional pathway can be found at: Provisional determination: A step-by-step guide for prescription medicines.