Australian drug regulator releases first batches of locally made AstraZeneca vaccine


More than 800,000 locally manufactured doses of the AstraZeneca vaccine have been approved for release to Australians providing a significant boost to the country’s rollout effort.

The Therapeutic Goods Administration announced on Tuesday evening it had approved the release of four batches manufactured at CSL-Seqirus’s Melbourne facilities. They comprise a total 832,200 doses.

The approval follows two previous TGA ticks for the AstraZeneca vaccine. The first approval was for the internationally manufactured version of the vaccine and the second – on the weekend – allowed the shots to be manufactured in Australia.

The Australian regulator tested the four CSL batches at its laboratories in Canberra and reviewed extensive manufacturing documentation to ensure the vaccine performed in the same way as the internationally manufactured vaccine – and was of the same quality.

“The TGA’s clearance of the vaccine for local manufacture is a major step in Australia’s response to the Covid-19 pandemic,” the regulator said in Tuesday’s statement. “We will now be able to provide secure access to large numbers of doses of a domestically-produced vaccine, with the Australian government having procured 50m doses for delivery in the coming months.”