Australian nod for Pfizer's COVID-19 bivalent booster dose vaccine

17 November 2022

Australia’s Therapeutic Goods Administration (TGA) has granted a provisional determination to US pharma giant Pfizer’s (NYSE: PFE) bivalent COVID-19 vaccine candidate: tozinameran and famtozinameran (Comirnaty bivalent Omicron BA.4/BA.5 COVID-19 vaccine).

The vaccine comprises mRNA for both the original and Omicron BA.4 and BA.5 strains and is for proposed use as a booster for active immunisation to prevent COVID-19 in individuals aged 12 years and older.

The new provisional determination means that Pfizer Australia Pty Ltd is now able to apply for provisional registration of this bivalent vaccine. Granting of the provisional determination precedes the provisional registration application and does not guarantee approval.

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