The Therapeutic Goods Administration (TGA) has granted provisional determination to Pfizer’s COVID-19 vaccine, Comirnaty™ as part of an application process to lower the approved age limit of vaccine administration from 16 years and above, to individuals aged 12 years and above.

Provisional determination is the first step in the provisional registration pathway. The provisional pathway for registration provides a formal and transparent mechanism for speeding up the registration of promising new medicines based on preliminary clinical data. Having provisional determination does not mean that provisional registration will be granted.

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Provisional determination granted to Pfizer in relation to COVID 19 vaccine, COMIRNATY – for use in individuals 12 years of age and older