Provisional determination granted to Pfizer in relation to COVID 19 vaccine (Comirnaty) - for use in individuals 6 months up to 5 years

TGA

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.

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Michael Wonder

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Michael Wonder