AstraZeneca’s Australia-made COVID-19 vaccine doses get TGA nod

The Australian drug regulator has given the green light to the local manufacturing of the COVID-19 vaccine developed by Oxford University and AstraZeneca Plc  The local manufacturer of the COVID-19 vaccine, CSL Limited, has released locally-manufactured vaccines ahead of the initial schedule.

The Therapeutic Goods Administration (TGA) had given the go-ahead to the biotech giant CSL Limited to produce AstraZeneca’s COVID-19 vaccine at its two manufacturing sites in Melbourne -Broadmeadows and Parkville.

On 24 March 2021, CSL announced that it had released 830,000 locally manufactured vaccine doses providing substantial support to the nation’s vaccine rollout effort.

The Company updated that there are an additional 2.5 million doses in cold storage, undergoing final stages of testing, approval, and release. The Company anticipates distributing these batches in the upcoming weeks.

The manufacturing process is ongoing, and the Company anticipates releasing an average of one million vaccine shots a week during the campaign, subject to regulatory authorisations.

The doses will be transported and stored between 2-8°C and distributed to health care professionals (HCPs) across Australia as part of the COVID-19 vaccine launch program of the government.

The TGA stated that it will still undertake batch testing for every batch of vaccine and all subsequent batches have to follow the same batch testing and release process. Each batch must be reviewed to verify that it has been manufactured as per the required standards.

The second phase “1B” of the vaccination program started on Tuesday, 23 March, with millions of individuals in the country set to become eligible for their first dose.

With the launch of Phase 1B programs, individuals aged 70 years and above, Aboriginal and Torres Strait Islanders aged 55 and above, younger Australians with underlying health conditions as well as frontline healthcare workers will be covered.

By Joe Cusmano