Australian-made vials of the AstraZeneca coronavirus vaccine are set to be released within days after the national medicine regulator approved domestic production.
Late on Sunday, the Therapeutic Goods Administration gave its blessing for pharmaceutical giant CSL to manufacture the AstraZeneca vaccine at its two Melbourne sites in Broadmeadows and Parkville.
The approval does not extend to use, however, with the regulator still needing to review batch documents and test to ensure they meet manufacturing standards.
But it said that was “imminent”, paving the way for domestically produced batches of the AstraZeneca vaccine to be shipped out “in the next few days”.
“Today’s approval is a critical and very exciting milestone in Australia’s response to the COVID-19 pandemic,” the TGA said on Sunday.
CSL has been charged with manufacturing 50 million doses of the AstraZeneca jab as part of an agreement struck with the federal government.
“These will form the mainstay of Australia’s COVID-19 vaccination program over the coming months, and complement imported vaccine supplies,” the TGA said.
The announcement coincides with the next stage of Australia’s vaccine rollout, which is facing further disruptions as heavy rain and flooding blocks roads in NSW.
The ‘phase 1b’ rollout – for people aged more than 70, Indigenous Australians over 55, those with a medical condition or disability, and workers deemed high risk – starts on Monday.
Throughout the coming week, more than 1000 general practices in cities and country towns across Australia will start administrating the AstraZeneca vaccine, with the aim to inoculate six million people.
“Obviously we won’t be able to vaccinate all six million people (on Monday), or over the coming week, so please be patient,” Deputy Chief Medical Officer Michael Kidd told reporters in Canberra on Sunday.
“At the moment, some general practices will only receive 50 doses a week and they will be prioritising their most elderly and most unwell patients.”
Authorities expect CSL to quickly ramp up production to a million doses a week once final approval is granted, Professor Kidd added.
In the meantime, the rollout of ‘phase 1a’ is expected to continue for another six to eight weeks until all people in that group have received two doses of the Pfizer vaccine.
Prof Kidd also reminded people to have their annual flu shot, which will become available over the coming month.
But importantly he said it is recommended there is a 14-day gap between having the COVID vaccine and the influenza vaccine.
There were just four COVID-19 overseas acquired cases recorded in Australia on Sunday, two in NSW and two in Queensland.
