TGA grants provisional determination to Pfizer’s COVID-19 bivalent (COMIRNATY BIVALENT OMICRON BA.4/BA.5) booster dose vaccine

On 15 November 2022, the Therapeutic Goods Administration (TGA) granted a provisional determination to Pfizer’s bivalent COVID-19 vaccine candidate: tozinameran & 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.

If an application for provisional registration is made, Pfizer is required to submit data from human clinical trials to the TGA before any decision to provisionally approve the product could be made. This is a legal requirement for the provisional approval of any vaccine or any other medicine in Australia. 

On 27 October 2022, the TGA provisionally approved a separate Pfizer bivalent COVID-19 vaccine, comprising the mRNA for the original and Omicron BA.1 strains for use as a booster dose in adults.

Contact for members of the media:

• Email: news@health.gov.au 
• Phone: 02 6289 7400