On 28 June 2022 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 5 years of age and older.
The granting of a provisional determination means that the TGA has decided that Pfizer is now eligible to apply for provisional registration for extending the use of this vaccine to children aged 6 months and older in the Australian Register of Therapeutic Goods.
In making its decision, the TGA considered all eligibility criteria, including evidence of a plan to submit comprehensive clinical data and the seriousness of the COVID-19 pandemic.
Provisional determination is the first step in the provisional registration process. Approval and potential supply in Australia would only commence should the vaccine be approved as safe and effective by the TGA and recommended for administration to this age group by ATAGI (the Australian Technical Advisory Group on Immunisation). It does not mean an application for use in this age group has been made and it does not mean any subsequent application would be approved.
On receipt of an application to provisionally register COMIRNATY for use in this age group, the TGA will undertake a rigorous assessment of the safety, efficacy and quality of this vaccine with the highest priority.