Pfizer’s Omicron vaccines move a step closer to TGA approval

COVID-19 cases are gradually declining across the globe. However, the recent outbreak of the Omicron variant at the start of this year has caused a serious havoc on the health and economic scenarios across different nations.

As of 06 July 2022, Australia has 282,003 active COVID-19 cases. As of 07 July 2022, over 95% of people in Australia are fully vaccinated and about 60% of the people aged over 65 years have received the winter/fourth dose of vaccination.

Image Source: © 2022 Kalkine Media®, Data Source: AU Government

This week, the Therapeutic Goods Administration (TGA) authorised provisional determinations to Pfizer Australia Pty Ltd for its two vaccines against the Omicron variant of COVID-19.

The two vaccines under the determination are:

Image Source: © 2022 Kalkine Media®, Data Source: TGA, Australian Government

Pfizer Australia Pty Ltd can now submit a provisional registration application to the TGA for the two vaccines after these two new provisional rulings. The COVID-19 pandemic's seriousness and Pfizer's plan to submit extensive clinical data were factors that the TGA considered when making its judgement.

The process for provisional registration begins with provisional determination. Notably, provisional determination approval precedes the application for market authorisation and is not a guarantee that the application will be approved. Pfizer has six months to submit the application for authorisation.

When the TGA receives a request to provisionally register COMIRNATY BIVALENT or COMIRNATY OMICRON, it will immediately begin a thorough evaluation of the vaccines' quality, effectiveness, and safety.