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Professor John Shine slams AstraZeneca vaccine myths


One of Australia’s top scientists has hit back after “significant misunderstandings” about the effectiveness of AstraZeneca’s coronavirus vaccine.

Professor John Shine is urging people to be aware of misinformation on social media and instead listen to advice from health departments, chief medical officers and scientists.

His message comes after experts, who spoke out about concerns the AstraZeneca vaccine would not achieve herd immunity, were hauled before a government education session following fears their comments were harming public confidence.

The Australian Academy of Science president said it was crucial the distinction be made between the vaccine’s effectiveness at protecting from severe disease and its effectiveness at stopping transmission.

“Vaccinated individuals will be protected from the worst of COVID-19 but will not be protected from becoming infected,” Professor Shine said.

“None of the vaccines that have been approved for use have demonstrated that they can stop transmission.”

RELATED: Aussies urged to watch out for COVID-19 misinformation

RELATED: Virus plea: ‘Listen to the experts’

Some infectious diseases experts joined calls to halt the vaccine rollout because they claimed that unlike the Pfizer vaccine, the AstraZeneca jab – which will be given to the majority of Australians – would not make most of the population immune to the infectious disease.

But Professor Shine said the primary goal of Australia’s vaccination strategy, which was supported by the academy, was to reduce the number of people getting very sick or dying.

He said both the AstraZeneca and Pfizer vaccines were equally effective at that, adding that Australia would benefit from growing data on vaccine doses and effectiveness as they are rolled out in countries with the greatest need.

“Australians should get vaccinated,” Professor Shine said.

“(They) can be confident that vaccines approved for use by the Therapeutic Goods Administration will be safe and effective.

“It will allow us to avoid a major wave of illness like that currently being experienced in the northern hemisphere.”

The federal government is now expected to include information about herd immunity in its public information campaign.

It is unclear if herd immunity will be achieved by any of the coronavirus vaccines because it is not known how long immunity from the jab will last.

The TGA is expected to approve the Pfizer vaccine by the end of January, with a rollout pencilled in for mid to late February for five million Australians in priority groups.

The AstraZeneca vaccine is expected to have completed the approval process in February and will then be rolled out to other Australians.



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Chief medical officer Paul Kelly responds to AstraZeneca vaccine concerns


Australia’s chief medical officer Paul Kelly has defended the decision to roll out the AstraZeneca vaccine in the wake of concerns about its effectiveness.

Infectious diseases experts have joined medics in calling for authorities to halt the rollout in favour of coronavirus vaccines with higher efficacy rates to ensure herd immunity.

This follows results from several trials that showed that the Oxford University-AstraZeneca jab had an efficacy rate of between 62-90 per cent depending on the doses.

Professor Kelly said AstraZeneca vaccine was well above the World Health Organisation’s 50 per cent efficacy threshold.

“All of the three vaccines that have so far published their data in peer-viewed journals – AstraZeneca, Pfizer and Moderna – show a very significant effect against severe illness,” he said on Wednesday.

“They’re all good at protecting against severe illness and death. That’s why I say that lives will be saved by the AstraZeneca vaccine, I have no doubt about it.”

RELATED Virus plea: ‘Listen to the experts’

He conceded he was troubled by what he called “selective” reporting over AstraZeneca’s efficacy, warning it could undermine confidence in the jab.

“Confidence is absolutely the most important thing, and that’s what worries me about the coverage we had today in relation to the AstraZeneca vaccine,” he said.

“People will be nervous, of course. We need to give more information and we’re doing that. So I am worried about the selective use of the data that we have.”

The Therapeutic Goods Administration (TGA) is expected to approve the Pfizer vaccine by the end of January, with a rollout pencilled for mid to late February for five million Australians in priority groups.

The AstraZeneca vaccine is expected to have completed the approval process in February.

Professor Kelly said the jab would prevent death and severe illness 100 per cent of the time, like the Pfizer vaccine.

He said both vaccines would only be rolled out if they had the full tick for safety, efficacy and production quality.

“The EU has also pre-purchased 400 million doses of AstraZeneca, the US has pre-purchased 300 million doses of AstraZeneca, and the UK 100 million doses of AstraZeneca. So we‘re not an outlier there,” he said.

The UK has already begun immunising people with the jab under emergency approvals.

Most Australians are expected to get the AstraZeneca vaccine because it can be made in Melbourne, unlike the Pfizer vaccine that has to be imported from overseas due to its mRNA technology.

Infectious diseases physician Professor Peter Collignon told Sunrise that the AstraZeneca vaccine might not be as good as the Moderna and Pfizer vaccines.

But he said those would be in short supply because they were not readily available and had to be stored in minus temperatures.

“I would be all for rolling out this (AstraZeneca) vaccine because it is much better than anything that is going to be available for quite a while,” Professor Collignon said.

Health Minister Greg Hunt on Tuesday refuted claims the government was conceding its vaccine strategy would not provide herd immunity.

“This is what the medical expert panel of Australia, the one that has helped keep us safe, has recommended,” Mr Hunt said.

In the wake of efficacy concerns, Labor leader Anthony Albanese told 2GB that the government should have invested in six vaccine candidates instead of three.

The opposition has long called for the rollout of the vaccine to be brought forward following the approval process.

But Mr Albanese said the party had never argued that authorities should circumvent the TGA process.

“We need to listen to the experts,” he said.

“Once it (the TGA) approves it, the vaccine should be rolled out.”



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Herd immunity concern shouldn’t pause AstraZeneca COVID vaccine rollout


Medical professionals are urging the Morrison Government to pause the planned rollout of the AstraZeneca vaccine, but other experts disagree.

Doubts are being raised about the ability of the vaccine, developed in co-operation with the University of Oxford, to control the coronavirus after Phase III clinical trial results published in The Lancet last month, showed it is only 62 per cent effective in preventing COVID-19.

The Australian and New Zealand Society for Immunology believes this may not be effective enough to generate herd immunity and it would be wise not to rely on it to control the virus in Australia, the Sydney Morning Herald reported.

Based on current trial evidence, Immunology Society president Professor Stephen Turner believes the vaccine should not be widely rolled out, especially when there are other vaccines from Pfizer and Moderna that are about 95 per cent effective.

Andrew Miller, an anaesthetist and head of the Australian Medical Association in Western Australia, is also calling for the Government to pause its rollout plans because without herd immunity, there would be no guarantee there wouldn’t be rolling epidemics.

“Once you have one vaccine, you may not be able to have other ones. That’s why it’s very important to get it right the first time,” he told The Australian.

But other experts have come out in support of the vaccine despite its lower efficacy.

Infectious diseases expert Professor Peter Collignon of Australian National University told Sunrise Australians would still be better off.

RELATED: Why Australia is waiting so long for vaccine rollout

“Yes it’s not perfect, it may not be as good as the Moderna and Pfizer vaccine, but they’re going to be in short supply, not readily available,” he said.

He also pointed out that the Pfizer vaccine had to be stored in very cold temperatures of -70C and so in the field its efficacy might not be as good as the stated 90 per cent, if it was not stored properly and so not active when it was given to people.

Prof Collignon said the AstraZeneca vaccine would still save lives.

“The reality is we’ve got a vaccine that will be (available) in large numbers in Australia (and) have 70 per cent efficacy – that’s terrific news,” he said.

“Remember, wearing masks you probably have 15 or 20 per cent efficacy when there is a lot of transmission, but if you can improve that to 70 per cent by a vaccine that lasts all the time, you’re much better off.

“If this was available in the Melbourne outbreak, hundreds of lives would have been saved of people who otherwise would have died.”

Infectious diseases physician Professor Greg Dore of the Kirby Institute at the University of NSW also tweeted that a rapid vaccine rollout was needed from February, not a pause.

“Give Pfizer vaccine to frontline HQ & HCW staff & the elderly,” he said of the more effective vaccine.

“I’ll be happy to have the AstraZeneca-Oxford vaccine, particularly if means we can get large majority done by winter.”

Australia’s chief medical officer Professor Paul Kelly said the advantage of the AstraZeneca vaccine was that it would be readily available in Australia.

RELATED: Vaccine rollout will not end restrictions in Australia

“There will be plenty to vaccinate the entire population of Australia twice,” Prof Kelly told Sunrise.

Australia has secured 53.8 million doses of the vaccine, with people required to get two injections. It will be made by the Melbourne-based company CSL.

In contrast, Australia has only secured enough Pfizer vaccine for five million people.

Prof Kelly said the Therapeutic Goods Administration’s (TGA) assessment of the AstraZeneca vaccine would be based on extra data and not just the Phase III trial results published in The Lancet.

While the AstraZeneca vaccine was shown only to have a 62 per cent efficacy rate, this did rise as high as 90 per cent in a small group of volunteers who received a half-dose for their first jab by mistake. However, this has also raised concerns about how effective the vaccine actually is.

Even if the AstraZeneca vaccine was only 62 per cent effective, Prof Kelly said this still exceeded the World Health Organisation standard of 50 per cent effectiveness.

“One thing is clear though from those interim results is that this vaccine is very effective against severe disease, just exactly the same as Pfizer and Moderna data,” he said.

However, Labor’s health spokesman Chris Bowman has criticised the Morrison Government for not signing deals for more vaccine options and also wants a faster rollout.

“The trouble with (the) call for a pause … is that there’s nothing to replace AstraZeneca in the Australian context,” Mr Bowman told ABC radio’s RN Breakfast program.

“We don’t have deals with Moderna and J&J for example. That’s why it would be better if we had more deals and we’ve been saying that for months.

“We don’t know yet whether AstraZeneca will even pass the TGA test, we hope it will, it probably will, but there’s always risk.

“That’s why the Federal Government should have been months ago spreading that risk more thinly with more deals.”



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AstraZeneca boss says transparency key for vaccine


The pause of the trial prompted global calls for more transparency on how COVID-19 vaccines are developed.

Mr Soriot, who is also a director of CSL, said he understood the desire for that transparency but that the integrity of trials also had to be protected. “We are looking at how much transparency we can provide considering we are in a very special set of circumstances,” he said.

AstraZeneca was working with other vaccine makers to discuss how open they could be about their studies without compromising the data they were collecting, Mr Soriot said.

It was also critical that citizens trusted that vaccines would be reviewed by several global regulators before being commercialised. “At the end of the day, people have to accept that they have to trust someone at some point,” he said.

Johnson & Johnson's chief scientific officer Dr Paul Stoffels.

Johnson & Johnson’s chief scientific officer Dr Paul Stoffels.

“You are going to have several sets of eyes from different countries looking at this.”

He cautioned medicine should not be practiced “by the media” but by experts reviewing the facts.

AstraZeneca is conducting its phase 3 trial of the Oxford vaccine and it is hoped that it could be available, including in Australia, in the first months of 2021 if successful. Mr Soirot said the distribution of the vaccine would be the next logistical challenge for manufacturers who managed a successful product. “One thing people tend to forget is that you need results, but also you need manufacturing,” he said.

Chief scientific officer of Johnson & Johnson, Paul Stoffels, who was also on the panel, said Johnson & Johnson’s vaccine project could be ready for emergency use at the very start of next year should its phase 3 trial be successful.

Mr Stoffels warned the company wanted enough data to ensure safety before it moved forward, however, and that the rollout may take some months.



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AstraZeneca virus trial pause highlights painful immunity truth


For a while there, it almost looked like we could have had a coronavirus vaccine in just months.

Trials of several candidates, including the much vaunted Oxford vaccine, which Australia has backed, were showing promising results.

US President Donald Trump was so confident that on Monday he said “we’ll have the vaccine soon, maybe before a special date”. That “special date” almost certainly refers to the November 3 polling day.

And then came today’s sobering reality check that trials of the Oxford COVID-19 vaccine, which the Government has pre ordered 30 million doses of, has been halted following an “unexplained illness” in one of the people given the shot.

Virus experts have said the brutal truth of vaccines is they often take years to develop. With all the will in the world, there’s only so many months you can shave off that timeline. Any hope that we might be celebrating the end of COVID over Christmas lunch is likely to be dashed.

“For the general public, a vaccine would probably be later in 2021,” an immunologist has told news.com.au.

RELATED: Follow our live coronavirus coverage

UK-Swedish pharmaceutical giant AstraZeneca has said phase III trials of the Oxford vaccine were being paused following what is referred to in the pharmaceutical industry as an “adverse event”.

“This is a routine action that has to happen when there is potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials,” the company said in a statement.

AstraZeneca insisted the illness was a “single event” but did not give any details as to what the patient came down with.

Mild side effects, such as fever, headaches and localised pain, had already been noted and were considered mild or moderate. As such, it’s likely the adverse event was more serious. Although the patient is set to recover.

The firm and Oxford University will likely spend several weeks trying to gauge if the person randomly came down with something, or if it’s linked to the vaccine. They will also be watching carefully to see if anyone else on the trial suffers the same malady.

All this takes time. And it illustrates the tension between just how impatient the world is to get back to normal and the many years it can take to develop a safe and effective vaccine.

RELATED: How hopeful should Australians be about coronavirus vaccine deal?

‘DANGEROUS TO PUSH TOO HARD’

Speaking to the ABC’s 7.30 on Tuesday night, University of Queensland immunologist Professor Paul Young said the expectation on how quickly a vaccine could be rolled out was unrealistic.

“The likelihood of any vaccine being deployed before Christmas is unlikely. It’s dangerous to push too hard.

“The timelines we have been working with are nothing like we have ever experienced before,” he said.

“I know that there is urgency and there is a desire to get something out there more quickly than perhaps it could do, but we are accelerating this as fast as possible.”

Last week, the World Health Organisation also warned against betting on an early jab for the virus.

“We are not expecting to see widespread vaccination until the middle of next year,” the WHO’s Margaret Harris said in Geneva.

“Phase III must take longer because we need to see how truly protective the vaccine is and we also need to see how safe it is.”

RELATED: Vaccine success but there’s a catch

PHASE III IS WHERE THINGS GO WRONG

Right now, a whole heap of vaccines are making their way down the approval pipeline.

Most are at the preclinical stage, where they are being tested on animals to see if an immune response is triggered.

A potential vaccine from the University of Queensland, which the Australian Government has also bet big on pre-ordering 51 million doses, is at this stage.

Just a handful have progressed to human trials: the Oxford/AstraZeneca vaccine, a US- German candidate which has the backing of pharma giant Pfizer and two Chinese potentials.

Human trials begin at phase I, when a small cohort are given a dose, and proceed to phase III, when the drug has proved to be safe enough up for thousands to take a dose.

Phase III is also where the process slows because so many people are involved. Getting from approval to production can take usually between two and 10 years to be approved.

“The development of a COVID-19 vaccine has been surprisingly smooth,” immunologist and RMIT research fellow Dr Kylie Quinn told news.com.au.

“But phase III is where they can fall down. This is where things can go wrong and that’s where we have to see in the real world if the vaccine can protect people but also if there are any rare side effects.”

The Oxford trial involved 30,000 people. Half the cohort were given the real jab with the rest getting a placebo. Around 17,000 people had commenced on the trial when it was halted.

“One event in 17,000 people is rare but they are doing there due diligence,” said Dr Quinn.

RELATED: Truth about Morrison’s ‘no jab, no pay’ policy

OPERATION WARP SPEED

Trump is betting on what’s he’s calling “Operation Warp Speed”, a $14 billion push behind two vaccines including Pfizer’s to find a vaccine and start cranking it out at, as the name suggests, at warp speed.

At a rally last week, the President was bullish, telling the crowd: “It will be delivered before the end of the year, in my opinion, but it really might even be delivered before the end of October”.

Not even Operation Warp Speed’s own staff seem that gung-ho.

Talking to the US’ National Public Radio last week, chief adviser for the program Moncef Slaoui said a vaccine by the end of next month was “a possibility, but very unlikely”.

But he “firmly believed” high risk groups, those over 70 and frontline healthcare workers, in the US could begin to be vaccinated by the end of December.

Dr Quinn said the approval process was going as fast as “humanly possible”.

“I’ve been really impressed about how rapidly things are moving forward and lot of that has been by reducing bureaucratic and logistical hurdles but ensuring we still get the same safety and immunity data.

“But there are some things we can’t compromise on,” she said.

“Early batches of a vaccine could be available next year for high risk groups and that’s sensible to prioritise; but for the general public a vaccine would probably be later in 2021.”

It’s a vaccine reality check and a stark reminder you can only rush the process so much.

However, there was good news too, said Dr Quinn.

Firstly, this could just be a bump in the road for the Oxford vaccine. The adverse event may not be connected to the drug or it may mean the vaccine is not prescribed to certain groups.

But even if it doesn’t pass muster, all is not lost.

“If it doesn’t go forward the great thing is we have multiple other vaccines in the pipeline.

“We have a number of equally good cards up our sleeves.”



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AstraZeneca to make Oxford COVID-19 vaccine


The experimental shot could reach late-stage trials by the middle of the year, ranking as one of the most advanced vaccine projects. Astra said Thursday it would join in the development as well as manufacture and distribute the product.

The vaccine developed by a team headed by Oxford’s Sarah Gilbert entered human testing last week. It’s one of at least 70 projects under development against the new virus, Sars-CoV-2. As the number of coronavirus infections globally exceeds 3 million, the pressure is growing to come up with solutions to the contagion.

The Trump administration’s “Operation Warp Speed” program will pull together private pharmaceutical companies, government agencies and the military to try to cut the development time for a vaccine by as much as eight months, according to two people familiar with the matter.

The Oxford team’s vaccine candidate is a single shot that’s been administered to 320 people so far, who reported mostly flu-like symptoms, headaches and arm soreness. AstraZeneca didn’t provide financial details of the agreement.

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GlaxoSmithKline, Astra’s UK rival and one of the world’s biggest vaccine makers, has joined forces with France’s Sanofi on separate development work.

Astra plans to rely on contract manufacturing organisations and other partners globally while ramping up its own production capacity, Soriot said. A vaccine is the “number one tool” the company can try to bring to the pandemic, he said.

Based on the agreement with the government and Oxford “for the period of the pandemic we will be supplying the vaccine at cost,” he said. He said he expects it to be accessible and affordable.

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