Provisional determination has been granted to Pfizer’s Covid-19 vaccine (Comirnaty) – proposed for use in children 5-11 years.
Comirnaty is provisionally approved for use in individuals 12 years of age or older. The granting of this determination means that Pfizer is now eligible to apply to vary the provisional approval for the vaccine to include children aged 5 to 11 years.
This provisional determination is the first step in the process and does not mean that an application for variation has been made by the sponsor – or that any such variation will be provisionally approved by the TGA.
In making its decision to grant Pfizer a provisional determination for use in individuals 5 to 11 years, the TGA considered 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.