30 June 2022 - On 28 June 2022, the TGA granted a provisional determination to Pfizer Australia 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.