Provisional determination granted to Pfizer in relation to COVID 19 vaccine (Comirnaty) - for use in individuals 12 years of age and older

13 May 2021 - On 11 May 2021, the Therapeutic Goods Administration granted a provisional determination to Pfizer Australia in relation to its COVID-19 vaccine (Comirnaty).

Currently, Comirnaty is provisionally approved for use in adults 16 years of age or older. 

The granting of this determination means that Pfizer is now eligible to apply to vary its provisional registration for the vaccine for use in individuals 12 years and age or older.

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Michael Wonder

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Michael Wonder

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Outcome , Vaccine , Paediatrics , COVID-19