On 12 October 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 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.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.