Approval of Australian produced AstraZeneca vaccine issued as US authorities ask for more accurate data

US authorities have not approved AstraZeneca vaccine citing issues with efficacy data in vaccine trial
US authorities have not approved AstraZeneca vaccine citing issues with efficacy data in vaccine trial

Australia has approved the release of locally-manufactured AstraZeneca vaccine with more than 800,000 doses set for dispersal, but at the same time US authorities are delaying their approval with concerns about vaccine trial data.

News out of the US this week saw AstraZeneca and Oxford collaborators release vaccine trial results showing the vaccine have a 79 per cent efficacy in symptomatic cases of COVID-19 and 100 per cent efficacy for severe cases.

The US Data and Safety Monitoring Board responded with concern that their was "outdated" data in the trial.

"We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible."

To date more than 50 countries, including Australia and many EU nations, have approved AstraZeneca vaccine.


The Therapeutic Goods Act said its clearance of the vaccine for local manufacture "is a major step in Australia's response to the COVID-19 pandemic".

"TGA testing of the vaccine batches in our Canberra laboratories plus review of extensive manufacturing documentation, has ensured that the locally-manufactured vaccine has the exactly the same composition and performance as the overseas-manufactured vaccine, the same quality, and is free of contaminants," it said.

"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 50 million doses for delivery in the coming months."

This week, Tasmania launched its GP-led stage of the AstraZeneca roll out, with 20 Tasmanian medical practices including Newstead Medical due to administer the vaccine.

This story Approval of Australian-produced AstraZeneca vaccine as US "concerned" by trial data first appeared on The Examiner.