The AstraZeneca COVID-19 vaccine has been granted provisional approval by Australia’s regulatory body.
The Therapeutic Goods Administration on Tuesday announced the vaccine had been approved for the active immunisation of individuals 18 years and older.
Initial supplies of the vaccine will be imported into Australia from overseas before doses are manufactured locally.
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“Australians can be confident that the TGA’s review process of this vaccine was rigorous and of the highest standard,” the regulator said in a statement on Tuesday.
“The decision to provisionally approve the vaccine was also informed by expert advice.”
The provisional vaccine approval is valid for two years and means it can now be legally supplied in Australia.
The TGA says the vaccine prevents the virus itself but it’s not yet known whether it prevents “transmission or asymptomatic disease”.
Health Minister Greg Hunt said it was his advice that the first doses would arrive from overseas in “early March, if not sooner”.
The CSL facility in Melbourne will then be ready to manufacture doses locally in late-March.
It becomes the second vaccine to receive regulatory approval in Australia.
The first jabs of the Pfizer vaccine will be administered from Monday after a shipment of 142,000 doses landed in Australia.
Australia has secured about 150 million doses of different vaccines including 20 million of the Pfizer drug.
Hotel quarantine workers, frontline health staff and aged care and disability residents are first in line.
Rollout plan
Australia’s vaccine rollout will be staged in five phases.
Phase 1a commences Monday, February 22.
Up to 1.4 million doses of the Pfizer vaccine will be offered to quarantine and border workers, frontline healthcare workers and aged care and disability care residents and workers.
Phase 1b will incorporate up to 14.8 million doses.
Elderly adults aged 80 years and over, elderly adults aged 70-79 years, other healthcare workers, Aboriginal and Torres Strait Islander people aged over 55, younger adults with an underlying medical condition and critical and high-risk workers including defence, police, fire, emergency services and meat processing personnel are included in Phase 1b.
Phase 2a will comprise of up to 15.8 million doses.
It will be offered to adults aged 60-69 years, adults aged 50-59 years, Aboriginal and Torres Strait Islander people 18-54 and other critical and high-risk workers.
Phase 2b includes up to 16 million doses.
It is then the vaccine will be offered to the rest of the adult population.
Phase 3 is up to 13.6 million doses and will be offered to people under 16 years old if it is recommended by the TGA.
- with AAP