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 this morning.
This week, more than 1000 GPs in cities and country towns across Australia – including 84 in South 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 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.”
Adelaide’s phase 1b rollout across 70 metropolitan GPs will be managed by Adelaide Primary Health Networks.
Adelaide PHN CEO Deb Lee called for patience as clinics come to grips with the next stage of the vaccination program.
“This is a milestone day for clinics in South Australia as they begin the process of administering the phase 1b vaccine,” Lee said.
“It’s really important that people understand whether they are eligible and, if so, that they don’t have to attend their regular GP to receive the vaccine.
“I would also urge people to be patient. We are working closely with SA Health analysing population data and focus areas to ensure that our most vulnerable community members are vaccinated first.”
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.
Australia’s deputy chief medical officer also reminded people to have their annual flu shot, which will become available this 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.
There are still 14 active cases of COVID-19 in SA – all in hotel quarantine.
SA Health said the state had administered 14,365 vaccine doses as of Saturday.
– with AAP
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