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Australia Scientists call for pause on AstraZeneca vaccine rollout

01:51  13 january  2021
01:51  13 january  2021 Source:   brisbanetimes.com.au

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The pause stemmed from a standard review of the company’s vaccine trials after one person developed an unexplained illness, AstraZeneca said in a statement. The move was intended to give researchers time to examine safety data while maintaining the integrity of the trials, the company said.

Internal AstraZeneca safety report sheds light on neurological condition suffered by vaccine trial participant. Krumholz and other scientists said the nature of the At first, AstraZeneca and Oxford called it an "unexplained illness." The trial was paused worldwide while the illness was investigated.

Professor Stephen Turner, Head of Microbiology, Biomedical Discovery Institute, Monash University. Handling culture medium in flasks used for growing and studying virus-specific T cells.Professor Turner is a leading expert on the immune system. He says there is some chance the cold virus may generate cross-reactive immunity to SARS-CoV-2. 20th August 2020 The Age News Picture by JOE ARMAO © Joe Armao Professor Stephen Turner, Head of Microbiology, Biomedical Discovery Institute, Monash University. Handling culture medium in flasks used for growing and studying virus-specific T cells.Professor Turner is a leading expert on the immune system. He says there is some chance the cold virus may generate cross-reactive immunity to SARS-CoV-2. 20th August 2020 The Age News Picture by JOE ARMAO

The Australian and New Zealand Society for Immunology says the federal government should immediately pause the planned rollout of the AstraZeneca vaccine because it may not be effective enough to generate herd immunity.

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AstraZeneca 's pause of its experimental coronavirus vaccine due to the illness of a participant is a "wake-up call " but it should not discourage researchers, says the World Health Organization's chief scientist . Key points: The WHO had flagged the AstraZeneca vaccine , which is being developed

09 September 2020 14.15 BST. As part of the ongoing randomised, controlled clinical trials of the AstraZeneca Oxford coronavirus vaccine , AZD1222, a standard review process has been triggered, leading to the voluntary pause of vaccination across all trials to allow an independent committee to

Phase three clinical trials of the vaccine, which is the centrepiece of Australia's vaccination strategy, show it is only 62 per cent effective in preventing COVID-19 when given in the recommended dose. Trials suggest vaccines from Pfizer and Moderna are about 95 per cent effective.

Immunology society president Professor Stephen Turner said based on current trial evidence the AstraZeneca vaccine should not be widely rolled out.

"The AstraZeneca vaccine is not one I would be deploying widely, because of that lower efficacy," he said. "You cannot rely on it to establish herd immunity."

"Given we have fantastic vaccines against this, I think it would be wise to not rely on the AstraZeneca vaccine for controlling the virus in Australia. But it could be used as a tool to blunt the effect of COVID until those vaccines could be deployed."

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Scientists are demanding to know why AstraZeneca ’s trial of its Covid-19 vaccine is still on hold in the US while it has been restarted elsewhere, worrying it could He said it was “disastrous” that details of the illness had been aired in a private call with AstraZeneca and investors, and called for Operation

The case prompted a pause in AstraZeneca ’s vaccine trials to allow for a safety review by independent experts. The vaccine being developed by AstraZeneca , which formed a partnership with Oxford University scientists , uses a virus meant to carry coronavirus genes into human cells and

There are no questions about the safety of the vaccine. Trial data suggests it offers potentially complete protection against life-threatening illness, meaning that even if people become infected the disease could be less damaging.

On Tuesday, the Australasian Virology Society confirmed to The Age and The Sydney Morning Herald that it supported an immediate pause in plans to roll out the AstraZeneca vaccine until research proved it was effective enough to achieve herd immunity.

But following a furious internal debate, the president of the virology society contacted The Age and the Herald late on Tuesday evening to say it had changed its position and no longer opposed the rollout of the vaccine.

When asked why the society was changing its official position at the last moment, its president, Professor Gilda Tachedjian, said: "That's for us to know and you to find out".

When will AstraZeneca's COVID-19 vaccine be available in the US?

  When will AstraZeneca's COVID-19 vaccine be available in the US? In the UK, vaccines Pfizer, Moderna, and AstraZeneca are being used to fight the pandemic. AstraZeneca's hasn't been approved for use yet in the US. AstraZeneca may not apply for a US FDA Emergency Use Authorization until the spring. The data from their UK trial was "odd" and had one "pretty serious error" in it, a US vaccine expert said. AstraZeneca is now conducting a larger trial of nearly 30,000 people in the US. Visit Business Insider's homepage for more stories. The UK now has three different COVID-19 vaccines in use to fight the pandemic, while the US has just two.

AstraZeneca paused trials earlier this week due to a potentially unexplained illness. Phase three trials for AstraZeneca 's coronavirus vaccine have resumed in the U.K. after they were halted earlier this week over safety concerns, raising hope that one of the leading candidates in the global race to

An AstraZeneca spokesperson confirmed the pause in vaccinations covers studies in the U.S. and other countries. Late last month, AstraZeneca began recruiting 30,000 people in the U.S. for its largest study of the vaccine . It also is testing the vaccine , developed by Oxford University, in thousands of

"One reason is we don't want to undermine the confidence in the vaccine. And we don't have the full picture. We need to go with the most effective vaccine so we can have herd immunity. But we just don't have the full picture at the moment with the AstraZeneca vaccine."

Speaking before the virology society's position changed, vice-president and spokeswoman Professor Heidi Drummer said 62 per cent effectiveness was not enough to achieve herd immunity.

"We should wait to see what data AstraZeneca provides to demonstrate higher levels of efficacy can be achieved with their vaccine and opt to use vaccines that achieve the highest level of efficacy to achieve herd immunity, whichever they are," she said.

"If it is 62 per cent efficacy, and that comes out in their further trials, I think there is a really good argument to make for the federal government to invest in the Pfizer and Moderna vaccines and use that in the wider community."

Professor Drummer later said she "had to stand by what the president says".

"I don't oppose the rollout of the vaccine provided we can see more data that shows that 90 per cent efficacy can be achieved," she said.

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Herd immunity means that such a large portion of the population is immune that a virus can no longer circulate and is eliminated.

Associate Professor James Wood, a University of NSW vaccine modeller and member of the federal government's Australian Technical Advisory Group on Immunisation, said herd immunity was "the long game", and providing a vaccine that could protect life immediately was much more important, particularly given Australia had so far only bought enough Pfizer vaccine for 5 million people.

Phase three trial results from the AstraZeneca vaccine published in The Lancet this month show the vaccine was 62.1 per cent effective at preventing disease when given in standard doses.

However, in a small group of volunteers who accidentally received a lower dose, that rate rose to 90 per cent, creating significant uncertainty over the vaccine's true effectiveness. Not a single person given proper doses of the vaccine developed severe COVID-19.

Vaccines from Moderna and Pfizer have achieved greater than 90 per cent effectiveness, probably high enough to force the virus out of circulation if widely administered, Professor Drummer said.

The Australian government has secured 53.8 million doses of the AstraZeneca vaccine, with two injections required per person.

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It remains unproven if any of the vaccines can prevent transmission of coronavirus.

Professor Drummer said clinical data suggested the Pfizer and Moderna vaccines were far more likely to do so than AstraZeneca's, but more studies needed to be conducted.

Dr Andrew Miller, president of the Australian Medical Association's Western Australia branch, said a vaccine that did not provide herd immunity would not meet the public's expectations about returning to pre-COVID normal.

"We need it to be over 70 per cent effective - preferably over 80 per cent - to prevent significant transmission still continuing in the community," he said.

"We've got plenty of money, and we have got plenty of time because we have very good disease control. Why would we settle for the second-best option?"

Professor Julian Rait, president of the AMA's Victorian branch, said judgment on the AstraZeneca vaccine should be reserved until more data was available.

Burnet Institute director Professor Brendan Crabb said the federal government did a good job with limited information in choosing its vaccine candidates, but it should now review Australia's reliance on the AstraZeneca vaccine.

He said while AstraZeneca still might prove more effective in reality than clinical trials have suggested, at this stage the Pfizer and Moderna vaccines were looking significantly better at stopping people from getting COVID-19.

"Personally, I'd much rather have AstraZeneca than nothing. I would have it tomorrow. It is a highly safe and effective vaccine," he said.

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"But would I have a more effective one if I could? Yes I would."

Health Minister Greg Hunt denied on Tuesday the suggestion that administering AstraZeneca's vaccine essentially meant the government was giving up on herd immunity.

"We are listening to the Australian government medical experts. They are the ones choosing the vaccines. They have chosen on the basis an mRNA vaccine has never ever been done before for anything.

"There is a very strong history of different types of conventional vaccine being rolled out with high effectiveness. It's important to note that the results also show up to 90 per cent effectiveness more generally, with final results to come. And up to 100 per cent in relation to severe illness."

A spokesman for the Health Department said people "should be cautious around making assessments of its efficacy until the full data is released and the [Therapeutic Goods Administration] approval process has been conducted".

The government confirmed last year that people would be allowed to purchase vaccines privately.

A spokeswoman for AstraZeneca said the company had always maintained that various vaccines would be needed to combat COVID-19.

"More data will continue to accumulate, refining the efficacy reading and characterising vaccine efficacy over a longer period of time."

The number of people who need to be vaccinated to achieve herd immunity is known as the "critical vaccination level". It is calculated based on how effectively a virus is transmitting in a population.

The more infectious the virus, the higher the critical level. But our behaviour also plays a role. In places with better social distancing, we are already making it harder for the virus to spread, lowering the critical level.

Evidence suggests on average around the world every person infected with COVID-19 will go on to infect between two and three other people.

To achieve herd immunity and end the pandemic, vaccines need to lower that average to below one - so that, over time, the virus dies out.

This may have been achievable in Australia using AstraZeneca's vaccine, Professor Wood said.

However, the emergence of at least one more-transmissible variant of COVID-19 in Britain changed that picture and raised the critical vaccination level, probably to a level beyond that which AstraZeneca could achieve.

Answers to your 24 most pressing questions about the coronavirus vaccine, from side effects and costs to when you'll be able to get one .
Coronavirus vaccines are the main chance the US has to dig itself out of the pandemic, and 10.6 million people have gotten their first shots so far. People are desperate to get vaccinated so they can protect themselves, see loved ones, and return to normal. The rollout so far has been slow and messier than planned, but US health officials say they're hitting the gas pedal in the weeks ahead. Here's what you need to know about the vaccine, from timeline to cost and side effects. Have a burning question you don't see here? Email reporter Kimberly Leonard at KLeonard@insider.com.

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