Australian-manufactured AstraZeneca vaccine gets approved by regulator

The approval for the Australian made AstraZeneca vaccines comes after approval was granted for the overseas made vaccine on February 16.

Prime Minister Scott Morrison visits the CSL facility in Parkville Melbourne.

Prime Minister Scott Morrison visits the CSL facility in Parkville Melbourne. Source: AAP

Australia's medicines regulator, the Therapeutic Goods Administration, has granted approval for locally produced AstraZeneca vaccines. 

The regulator said the vaccines produced in Melbourne meet the same quality and safety standards as the overseas version.
"Specific approval of Australian manufacturing by TGA was required to ensure that the locally-manufactured vaccine had exactly the same composition and performance as overseas-manufactured vaccine, was made to the same quality and is free of contaminants," the TGA said in a statement.

The doses made in Melbourne will be released in the next few days.

The TGA said once the final batch release documents are received from AstraZeneca then the doses can be distributed.

"The final step for the Australian-manufactured vaccine is TGA batch release, which is required for each and every batch of any vaccine supplied in Australia.

"This involves a review of documents supplied by the commercial sponsor describing how the vaccine batch was made, tested, shipped and stored as well as TGA's in-house laboratory testing to ensure the vaccine has been manufactured according to the required standards."

CSL has been contracted to produce 50 million doses of the AstraZeneca vaccine. 

The next phase of the mass vaccination program begins on Monday, 22 March.

About six million Australians will be from places including GPs, federally-funded health clinics and Aboriginal health services. 

More than 250,000 virus jabs have been administered in Australia, a long way off the four million Prime Minister Scott Morrison said would be completed by the end of March.

There were just four COVID-19 overseas acquired cases recorded in Australia on Sunday, two in NSW and two in Queensland.

Professor Kidd said the result contrasts with the global situation where cases continue to be very high, with more than half a million reported in the past 24 hour-period along with almost 8500 recorded deaths.
Department of Health secretary Brendan Murphy is optimistic about the outlook, as long as most of the Australian population is vaccinated.

"I think life will return to normal, but I think we have just got to be patient," Professor Murphy told Sky News.

While the vaccines are safe, he said there are still a number of things that are not known about them including how long the protections will last, how good they are against variant strains of COVID-19 and whether people will need booster shots every year, like a normal flu jab.

Nonetheless, he expects the vaccine rollout will allow for a reduction of all restrictions and ensure state border closures are no longer required.

Additional reporting: AAP

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3 min read
Published 21 March 2021 6:05pm
Updated 21 March 2021 7:43pm
Source: SBS News



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