On 5 July 2022, the Therapeutic Goods Administration (TGA), part of the Department of Health and Aged Care, granted two provisional determinations to Pfizer Australia Pty Ltd in relation to COVID-19 vaccines that target the Omicron variant.
The determinations refer to the following vaccines:
- a monovalent COVID-19 vaccine, riltozinameran (COMIRNATY OMICRON), and
- a bivalent COVID-19 vaccine, tozinameran & riltozinameran (COMIRNATY BIVALENT).
Pfizer has developed COMIRNATY OMICRON vaccine candidate targeting the spike protein of the Omicron BA.1 variant of concern and COMIRNATY BIVALENT, a mixture of mRNAs for the original (ancestral) and Omicron BA.1 coronavirus strains.
These two new provisional determinations mean that Pfizer Australia Pty Ltd is now able to apply to the TGA for provisional registration for the COMIRNATY OMICRON and COMIRNATY BIVALENT vaccines for active immunisation to prevent COVID-19. In making its decision, the TGA considered evidence of a plan from Pfizer to submit comprehensive clinical data and the seriousness of the COVID-19 pandemic.
Provisional determination is the first step in the provisional registration process. Granting of the provisional determination precedes the market authorisation application and does not guarantee approval of the application. Pfizer has six months during which time the authorisation application must be submitted.
On receipt of an application to provisionally register COMIRNATY OMICRON or COMIRNATY BIVALENT, the TGA will undertake a rigorous assessment of the safety, efficacy and quality of these vaccines with the highest priority.