Key Points
- Pfizer is one step closer to rolling out two new vaccines.
- They would target the highly transmissible Omicron variant of COVID-19.
Pfizer is one step closer to rolling out two new vaccines which target the highly transmissible Omicron variant of COVID-19.
The Therapeutic Goods Administration (TGA) announced on Wednesday it had granted two provisional determinations to Pfizer Australia for its vaccines Comirnaty Omicron and Comirnaty Bivalent.
It means Pfizer is now able to apply to the TGA for provisional registration of the two vaccines and seek authorisation to bring them to market.
"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," the medicines watchdog said in a statement on Wednesday.
"The TGA will undertake a rigorous assessment of the safety, efficacy and quality of these vaccines with the highest priority."
As the nation grapples with rising case numbers, Prime Minister Anthony Albanese says the immunisation experts will look at available evidence before making a recommendation for a fourth COVID-19 vaccine dose.
"The pandemic isn't over, so my view is that [Australia] will inevitably follow what has occurred in other parts of the world and roll out a further booster shot," he said on Wednesday.
"I'd encourage people who haven't had their booster shots to go out there if they're eligible and do it as a matter of urgency."
The Australian Technical Advisory Group on Immunisation (ATAGI) is expected to discuss the benefits of expanding the fourth dose eligibility at their meeting on Wednesday.
It is currently available for Australians over 65 and vulnerable people.
Meanwhile, Victoria has extended its pandemic declaration by three months. The declaration was due to expire before midnight on 12 July, but has been extended until at least 12 October.
In a statement on Tuesday, Premier Daniel Andrews said COVID-19 continues to pose a "serious risk" to public health throughout the state.
This justified ongoing public health measures over winter to reduce the risk of transmission and hospitalisation, he said.
NSW Health Minister Brad Hazzard also warned that anyone who isn't fully vaccinated is "crazy" as the state braces for a third wave to peak in late July and early August.
The surge in cases is being driven by two Omicron subvariants, BA.4 and BA.5, and health experts believe the number of cases and deaths will continue to grow.
State and territory health experts are also considering whether to reintroduce mask mandates to curb the case increase.
NSW Chief Health Officer Dr Kerry Chant urged people to consider wearing masks in enclosed spaces to curb the spread of disease.
As Victoria's death toll rose above 4,000, Premier Daniel Andrews said he couldn't make it any clearer that vaccines worked.
However, he stopped short of telling Victorians to don masks outside of the current mandated settings such as health facilities, aged care and public transport.
On Tuesday there were 3,740 people with COVID in hospitals across the country, the highest levels since February during the height of the Omicron wave.
More than 36,000 infections were reported nationally and experts warn case numbers will climb even further as winter progresses.
no longer need to declare their vaccination status to enter the country.
