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Newcastle Herald
Newcastle Herald
National
Anita Beaumont

COVID-19 vaccine gets the tick of approval from TGA

Great news: University of Newcastle viral immunologist Associate Professor Nathan Bartlett is pleased with the way the TGA has handled the Pfizer vaccine approval. Picture: Jonathan Carroll

A HUNTER researcher has applauded the Therapeutic Goods Administration's decision to approve the Pfizer vaccine for COVID-19 after "the right amount of scrutiny".

A year after Australia's first confirmed case of COVID-19, the TGA granted "provisional approval" for use of the Pfizer/BioNTech COVID-19 vaccine, which is expected to be rolled out from late February.

Associate Professor Nathan Bartlett, a University of Newcastle viral immunologist, said it was "great news" for Australia.

"It clearly wasn't rushed," he said. "Clearly, the review of the available data was adequate - particularly looking at what was happening in the UK and US and other places."

He said the TGA would not have approved the vaccine was it not "safe".

Associate Professor Bartlett said the vaccine would require two doses, separated by at least three weeks.

"We definitely need that booster shot to get the efficacy of around 90 per cent-plus that has been reported from the clinical trials," he said. "The efficacy of a single jab is only around 50 per cent, so that second vaccination is vital to giving us those good numbers we need to properly protect the community.

"The TGA has done the right thing - paused to see how it's going in the rest of the world. Paused enough just to be sure that it is safe and there are no issues. But not paused too long as to put Australia way behind."

Up to 1.4 million doses will be required for the first stage of the vaccine rollout.

A priority group of Australians are expected to receive the first doses of the vaccine as soon it arrives in the country. "Group 1A" for the vaccine rollout includes quarantine and border workers, frontline healthcare workers, aged-care staff, aged-care residents and disability care staff and residents.

Prime Minister Scott Morrison welcomed the TGA's approval of the Pfizer vaccine after "our own" Australian experts found it "safe, effective and of a high standard".

"Australians should take confidence in the thorough and careful approach taken by our world-class safety regulator," he said.

The head of the TGA, Adjunct Professor John Skerritt, said tests for the vaccine to meet approval standards had been non-stop. They would continue to monitor its safety "post-approval".

"We're thrilled to have this product pass the rigorous regulatory process and receive provisional approval," he said.

N OTHER NEWS:

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