AstraZeneca coronavirus vaccine provisionally approved by TGA

There has been a huge breakthrough in Australia’s coronavirus battle, with the TGA provisionally approving the AstraZeneca vaccine.

The Therapeutic Goods Administration has given a second coronavirus vaccine the green light, as Australians anxiously await the rollout of the vaccination program.

The medical regulator announced today it had granted provisional approval to AstraZeneca Pty Ltd for its COVID-19 vaccine, making it the second COVID-19 vaccine to receive regulatory approval in Australia after approving the Pfizer vaccine in January.

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It’s good news for our vaccine roll out. Picture: Michael Dantas/AFP

It means the jab is provisionally approved and included in the Australian Register of Therapeutic Goods for the immunisation of individuals 18 years and over, with the vaccination of those aged over 65 should be decided on a case-by-case basis.

The exciting news broke during Victoria’s daily COVID-19 press conference, and chief health officer Brett Sutton said it was “terrific news”.

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Victoria's chief health officer Brett Sutton has welcomed the TGA’s approval of the jab. Picture: Wayne Taylor/Getty Images

“Who wouldn’t be delighted at the prospect of another vaccine, especially one locally manufactured, that will deliver millions of doses to Australians. I can’t wait to be vaccinated when my time in the queue comes. And looking forward to seeing it roll out across the country,” he said.

“I hope it lifts spirits. The mental health anguish of this pandemic has been extraordinary.

“It literally represents the beginning of the end of this pandemic as we roll out a vaccine so it is incredibly positive to see that development and know that Pfizer vaccine will start to

roll out in our hotel quarantine system, first ports of entry, our aged care and health sect or staff and residents is fantastic news.”

The approval allows the second dose to be administered from four to 12 weeks after the first, and the provisional approval of the vaccine is valid for two years, meaning it can now be legally supplied in Australia.

Prime Minister Scott Morrison addressed the nation this afternoon in the wake of the announcement, and said the vaccine’s approval was a breakthrough in the “enormous exercise” that is the national rollout.

“The vaccination program is critical to our ongoing management of the COVID-19 pandemic,” he said.

“And the vaccines that we have, they address the critical issue of serious disease and indeed, the risk of fatality that can arise from COVID-19 and increasingly we’re seeing positive signs about its impact on transmissibility as well.

“This is an enormous exercise that requires many steps. The planning of the strategy, the securing of the vaccines, going through the important approvals process which can give Australians confidence.”

He said the green light had been given only after a “full and thorough assessment process”, and said the approval meant Australia was one of the few countries in the world that can manufacture its own COVID-19 vaccine.

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Prime Minister Scott Morrison stressed the vaccine’s safety during a snap press conference. Picture: NCA NewsWire/Gary Ramage

“The vaccine has met requirements for standards, for safety, quality, and efficacy, and will be provided free to Australians and it means that Australia now has two safe and effective COVID-19 vaccines available,” he said.

“Initial supply into Australia will be imported from overseas. And in the coming months, the AstraZeneca vaccine will be manufactured here in Australia.”

Meanwhile, Health Minister Greg Hunt said the vaccine was “cleared for lift off”.

“They have taken the best advice from around the world. They have also had the opportunity to examine the advice and real world evidence gathered from the emergency use provisions in other countries,” he said.

“In particular, the Lancet journal said very recently in an article published on 3 February, 2021, COVID-19 vaccine AstraZeneca confirms 100 per cent protection against severe disease, hospitalisation, and death, in the primary analysis of phase three trials.”

Mr Hunt also confirmed the government was expecting at least 240 aged care facilities to be included in the vaccine program next week.

“That’s a very important step forward in protecting our older Australians,” he said, adding the AstraZeneca vaccine was now due to be rolled out in “early March if not earlier”.