AUS
NZ
UK
CA
USA
IND
Highlights
- Over 95% of people in Australia are fully vaccinated
- The TGA has approved provisional determinations of Pfizer Australia for two Omicron-specific COVID-19 vaccines
- The COVID-19 pandemic’s seriousness and Pfizer’s plan to submit extensive clinical data were the factors that the TGA considered when making its judgement
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.
