Senin, 15 Februari 2021

AstraZeneca vaccine approved, paving way for home-grown doses - Sydney Morning Herald

The AstraZeneca vaccine has been granted provisional approval by the medical regulator, paving the way for all Australians to receive a coronavirus vaccine by the end of the year.

The Therapeutic Goods Administration has approved it for adults aged 18 and over.

Professor John Skerritt from the Therapeutic Goods Administration said the vaccine is safe in adults.

Professor John Skerritt from the Therapeutic Goods Administration said the vaccine is safe in adults.Credit:Alex Ellinghausen

Head of the TGA Professor John Skerritt said Australia was only the second regulator in the world to give “full conditional approval of the vaccine” and said the approval “does not have an upper age limit”.

“Our analysis of the data gives us no reason to suspect that the vaccine would not be fully efficacious in older groups,” he said on Tuesday afternoon.


“What is important is to get vaccines into people’s arms.”

Prime Minister Scott Morrison said Australia’s relatively low case numbers allowed the TGA to go through a full approval process, instead of a faster emergency process as occurred in several other countries including the US, and rejected claims the approval process was slow.

“This has been, I think, the most efficient and timely process that the TGA has ever undertaken for any vaccine. And they’ve done it in a way which has cut no corner,” he said.

“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.

“Australia is one of the few countries in the world that can manufacture its own COVID-19 vaccine here by CSL.”

The AstraZeneca vaccine is the second coronavirus vaccine to be approved in Australia.

The Pfizer vaccine gained provisional approval last month, and people will begin receiving those vaccinations from next Monday.

Health Minister Greg Hunt said aged care homes will begin receiving vaccinations next week.

“We’re 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.

Mr Hunt thanked the TGA for working “extraordinary hours to tick every box, to assess everything, to make sure that safety, safety, safety, is the number one priority”.

“They and our medical professionals and all the companies involved have worked literally around the clock for a long, long period,” he said.

The AstraZeneca vaccine is the second coronavirus vaccine to be approved in Australia after the Pfizer vaccine gained provisional approval last month. More than 140,000 doses of the Pfizer vaccine arrived on Monday, in a major vaccination milestone. Pfizer is set to ship 20 million doses in total to Australia.

The country will have 53.8 million doses of the AstraZeneca vaccine, with 3.8 million imported from overseas and 50 million manufactured by CSL in Australia. The imported doses will begin arriving in the first week of March, and CSL’s first locally produced vaccines will be available later that month.

Most Australians will get the AstraZeneca vaccine, which Mr Hunt has previously described as the “ace in the hole” of the nation’s rollout.

Unlike the Pfizer vaccine, which requires storage at minus 70 degrees creating a number of logistical challenges for widespread distribution, the AstraZeneca vaccine only needs to be stored at 2 to 8 degrees, as is the case with most vaccines.

Professor Skerritt said it was unknown how long the vaccine would remain effective.

“We don’t have a crystal ball and we don’t know ... and maybe the vaccines provide two or three years of protection but not life. Maybe people will need a booster. No-one knows that yet,” he said.

He said Australians who have had COVID-19 should also receive a vaccine.

“There’s no advice saying don’t have it. And of course, in Australia, we’re fortunate that the numbers are small. But a number of other countries are vaccinating people who have had coronavirus. There’s no adverse event,” he said.

Professor Skerritt said pregnant women were not included in vaccine trials, as pregnancy excludes volunteers from clinical trials as a safety measure.

“However, there were a number of people who didn’t know they were pregnant or became pregnant during the trials, and there haven’t been reports of adverse outcomes.

“As the weeks and months go on, we’ll know a lot more about pregnancy with these vaccines.”

Developed by researchers at the University of Oxford and pharmaceutical company AstraZeneca, the vaccine is a “non-replicating viral vector vaccine”. Scientists have taken a virus that usually gives chimpanzees a cold but is harmless to humans, and genetically engineered it to look like SARS-CoV-2, the virus that causes COVID-19, to trigger an immune response.

Most people will receive their AstraZeneca vaccine in phases 2a and 2b of the rollout at a general practice vaccination hub, their local GP or approved pharmacy.

Earlier this month, CSL told The Sydney Morning Herald and The Age it was confident it could make updated versions of AstraZeneca’s COVID-19 vaccine to cover any virus variants that might arise.

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2021-02-16 01:28:00Z

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