Senin, 15 Februari 2021

AstraZeneca coronavirus vaccine approved for use in Australia by TGA - ABC News

Australia's medical regulator has approved the Oxford University-AstraZeneca coronavirus vaccine for use in Australia.

It is the second vaccine given the green light by the Therapeutic Goods Administration (TGA) after it approved the Pfizer vaccine last month.

In a statement the TGA said it had approved the vaccine for use in people aged over 18 years.

It said while people over the age of 65 "demonstrated a strong immune response" to the vaccine, there were not enough people infected by COVID-19 in the clinical trials to determine the overall efficacy for that age group.

"The decision to immunise an elderly patient should be decided on a case-by-case basis, with consideration of age, co-morbidities and their environment taking into account the benefits of vaccination and potential risks," it said.

Head of the TGA, John Skerritt, said there would be no upper age limit for the vaccine.

"The experience in the UK, in their rollout ... their experience is also of very good results obtained with both of the major vaccines in older groups," he said.

Professor Skerritt did not provide clearer guidance on advice for vaccines for pregnant women, but said women who had received jabs were being watched closely.

"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," he said.

He said those women and other frontline workers who had actively chosen to be vaccinated while pregnant were being "closely followed on a register".

"Those babies are yet to be born and so forth, again, there's no evidence of anything untoward such as miscarriage or illness during pregnancy," Professor Skerritt said.

The TGA said the advice was for two doses, 12 weeks apart, but if that was not possible, a minimum interval of four weeks between doses could be used.

Australia has secured 53.8 million doses of the AstraZeneca vaccine, 50 million of which would be made in Melbourne by medical giant CSL to guarantee future supply.

There were concerns about whether Australia would receive its order after the European Union introduced new rules on exports of COVID-19 vaccines produced within the bloc, including Pfizer.

But last week the EU's ambassador to Australia said the doses would be allowed to leave Europe.

The TGA said AstraZeneca had been shown to prevent COVID-19, the disease caused by the coronavirus, but it was not clear yet whether it prevented transmission or asymptomatic disease.

However, a recent study by Oxford University, which has not yet been peer reviewed, found the AstraZeneca vaccine not only prevented severe disease, but appeared to cut transmission of the virus by around 67 per cent.

Health Minister Greg Hunt said yesterday around 1 million doses a week from the end of March would be made available.

But the exact rollout date is still uncertain.

Unlike the Pfizer vaccine, which must be stored between -60 and -90 degrees Celsius, the AstraZeneca vaccine only needs to be stored at 4 degrees Celsius.

The decision comes a day after the first 142,000 doses of the Pfizer vaccine landed in Australia, with vaccinations due to start next Monday.

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2021-02-16 01:13:00Z

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