Yes, there’s confusion about ATAGI’s AstraZeneca advice. But it’s in an extremely difficult position


Daniel Pockett/AAP

Hassan Vally, La Trobe UniversityOne can totally understand the frustration around where the AstraZeneca vaccine fits in our vaccine rollout in Australia.

At a time when we’re grappling with so much uncertainty, we need unambiguous information from the federal government about who should have this vaccine.

Instead, it feels very much like we’re swirling in a murky sea of information that is confusing and, at times, seems to be contradictory.




Read more:
Morrison government orders Pfizer ‘boosters’, while hoping new ATAGI advice will warm people to AstraZeneca


The confusion is compounded by the changing advice from ATAGI. ATAGI, the Australian Technical Advisory Group on Immunisation, is the group of vaccine experts which advises the government.

There is no doubt that for many people, some of its language has been difficult to make sense of, including the use of vague terms like “preferred”. As in, the Pfizer vaccine is the “preferred vaccine” for those under 60 years of age.

How exactly this should be interpreted by someone trying to make the important decision about whether to get the vaccine is unclear, and raises more questions than it answers.

The public commentary from a number of political leaders, including the prime minister, that ATAGI has been too conservative and too risk averse hasn’t helped either, with the implication ATAGI cannot be fully trusted to provide sensible advice.

The reality is, ATAGI is in an extremely difficult position and is grappling with competing concerns, considerable uncertainty, and a constantly changing landscape.

What is ATAGI’s role?

ATAGI can only give general advice to the government for the whole population.

Its task is to think about the whole population as if it were merged into a single person, or in the case of AstraZeneca, a series of people of different age ranges. It then has to formulate advice based on population-based averages of the benefits and risks of getting the AstraZeneca vaccine, which has a number of limitations.

It’s important to understand context plays a key role in formulating this advice to the government. The risk of the blood clotting and bleeding condition, called thrombosis with thrombocytopenia, from the AstraZeneca vaccine is slightly higher for younger people.

This is only part of what’s driven the advice for Pfizer to be the preferred vaccine for those under 60.

In fact, the risk of dying from this condition is incredibly rare whatever your age.




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Concerned about the latest AstraZeneca news? These 3 graphics help you make sense of the risk


What has been the bigger driver of the advice is the fact you’re less likely to develop severe disease from COVID if you’re younger, which means the corresponding benefits of vaccination are much lower if you take a narrow view of the benefits of the vaccine being solely the prevention of severe disease.

How did ATAGI draw its conclusions on AstraZeneca?

ATAGI initially said Pfizer was the preferred vaccine for under-50s in April, and then changed this to under-60s in June.

There are several assumptions in ATAGI’s advice which need to be understood.

Firstly, it calculated the risks and benefits of AstraZeneca across three scenarios — low, medium and high exposure risk. ATAGI has presented its advice assuming a low amount COVID circulating in the community, which has been the case until Sydney’s latest outbreak.

A low amount of COVID in the community means there’s a low chance of severe COVID, which is even smaller for younger people. This means there’s less of a benefit of being vaccinated for younger people, which is what has driven the advice for the Pfizer vaccine to be preferred for younger people.

However, the problem with this low prevalence assumption is we’re vaccinating to protect us not just right now, but also against the future risk of COVID, and future lockdowns, like the situation we’re seeing in Sydney now.

Once you’re in this situation, even if ATAGI changes its recommendations in response to more COVID circulating, which it did on Saturday, in some sense the horse has already bolted.

Another assumption implicit in ATAGI’s advice that it prefers under-60s get Pfizer, is that Pfizer is available and you have the option to get it now.

However, given the limited supply of Pfizer vaccine, the decision to hold off on the AstraZeneca vaccine is not one to get Pfizer, it is one to hold off on getting vaccinated at all. This leaves you exposed and vulnerable to COVID. This is an important distinction to make, which of course will change as we get more Pfizer vaccine.

Another major limitation in the ATAGI advice is the panel, in dealing with population-level data, takes a very narrow view of the benefits of vaccination: the prevention of severe disease.

It doesn’t take into account other benefits that may be relevant to many people. It doesn’t take into account the prevention of long COVID; the benefits of being vaccinated allowing travel and other freedoms; and, most glaringly, the importance many people place on getting vaccinated to protect their loved ones and the community.

These may weigh heavily on individuals but aren’t taken into account when you look at the risk-benefit calculation from a narrow perspective.

So what’s the bottom line on AstraZeneca?

We must remember the AstraZeneca vaccine is a fantastic vaccine.

It’s safe and effective, and two doses offer almost complete protection against severe disease and death from COVID, including the Delta variant.

It does carry a small risk of the blood clotting and bleeding condition, but this risk is incredibly small. COVID is much more of a threat to your health than the vaccine, as we are seeing in NSW right now.

If you’re under 60 years of age, the decision to have the AstraZeneca vaccine is one only you can make. But if you do make it, you should understand the benefits go beyond just preventing severe disease.The Conversation

Hassan Vally, Associate Professor, La Trobe University

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Morrison government orders Pfizer ‘boosters’, while hoping new ATAGI advice will warm people to AstraZeneca


Michelle Grattan, University of CanberraWhile still struggling with a current shortage of Pfizer, the Morrison government announced it has secured 85 million doses of that vaccine for future “booster” shots.

This will be made up of 60 million doses in 2022, and 25 million doses in 2023. Delivery will start in the first quarter of next year.

Scott Morrison said on Sunday this was “prudent future proofing”, although there is still not definitive advice on when boosters will be needed.

Meanwhile the Australian Technical Advisory Group on Immunisation (ATAGI) has liberalised its advice on AstraZeneca.

It said in a statement on Saturday all people aged 18 and over in greater Sydney, including those under 60, “should strongly consider getting vaccinated with any available vaccine including COVID-19 Vaccine AstraZeneca”.

This was on the basis of the increasing risk of COVID and “ongoing constraints” of Pfizer, the advice said.

Last week Scott Morrison said the government was constantly appealing to ATAGI to review its advice on AZ according to the balance of risk. Many people have shied away from AZ, supplies of which are plentiful, after ATAGI’s caution about it for younger people because of rare blood clots.

Asked about some general practioners being reluctant to give AZ to people under 40, Morrison said he certainly hoped GPs “would be very mindful of the ATAGI advice”.

ATAGI is presently considering whether children between 12 and 15 years old should be vaccinated against COVID, with the government expecting advice in mid-August.

As the crisis continues in Sydney, on Sunday NSW reported 141 new locally acquired cases and two deaths, including a woman in her 30s. This followed Saturday’s report of 163 new cases in the previous 24 hours.

Victoria on Sunday reported 11 new local cases, and is on track to end its lockdown soon, as is South Australia.

Morrison again stressed the lockdown was the primary weapon in fighting the Sydney outbreak.

“There’s not an easy way to bring these cases down. And it’s the lockdown that does that work. The vaccines can provide some assistance, but they are not going to end this lockdown. What’s going to end this lockdown is it being effective.”

But NSW Premier Gladys Berejiklian, who tried unsuccessfully to get the vaccination program refocused on south west Sydney, the centre of the outbreak, has a different emphasis. “Please know that what will get us through this outbreak is a combination of our restrictions, but also of more people being vaccinated”.

Morrison has refused to alter the focus, saying this would “interrupt the rhythm of the national vaccine program”.

The federal government has found 50,000 extra Pfizer doses for NSW. Asked where these came from, Morrison said: “There are small variations in supply and delivery, which from time to time may ensure that there’s tens of thousands of doses that might be free at any given time.”

Morrison condemned Saturday’s Sydney anti-lockdown demonstration attended by thousands of people, which saw violence, dozens of people charged, and more being pursued where they can be identified.

He said it was not just selfish. “It was also self-defeating. It achieves no purpose. It will not end the lockdown sooner, it will only risk the lockdowns running further,” he said.

Asked about Queensland Nationals MP George Christensen, who attended a rally in Mackay, Morrison said: “As for other parts of the country that aren’t in lockdown, well, there is such a thing as free speech, and I’m not about to be imposing those sorts of restrictions on people’s free speech”.

Christensen said on Facebook, “Civil disobedience eventually becomes the only response to laws that restrict freedom. This is what we’ve seen in Melbourne today.”

Pressed on this, Morrison said: “The comments I made before related to an event that took place in Queensland where there are no lockdowns”.

The Prime Minister told the Liberal National Party state council in a virtual address on Sunday: “After a difficult start, the vaccine program is now making up lost ground, and quickly”.The Conversation

Michelle Grattan, Professorial Fellow, University of Canberra

This article is republished from The Conversation under a Creative Commons license. Read the original article.

The benefits of a COVID vaccine far outweigh the small risk of treatable heart inflammation


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Jonathan Noonan, Baker Heart and Diabetes Institute and Karlheinz Peter, Baker Heart and Diabetes InstituteRepeated COVID-19 outbreaks in Australia have once again highlighted the need for rapid and widespread vaccination. We are extremely fortunate the global scientific community has been able to develop a handful of highly effective vaccines in such a short time.

As with any vaccine or medicine, the COVID vaccines do carry small risks. The rare blood clotting disorder caused by the AstraZeneca vaccine — thrombosis with thrombocytopenia syndrome, or TTS — has largely dominated the headlines.

But we’re also seeing reports of a potentially increased risk of myocarditis and pericarditis (heart inflammation) following the mRNA COVID-19 vaccines, developed by Pfizer/BioNTech and Moderna.

Here’s why this shouldn’t be cause for concern.

First, what are myocarditis and pericarditis?

There are three main types of heart inflammation: endocarditis, myocarditis, and pericarditis. These involve inflammation of the inner lining of the heart, the heart muscle, and the outer lining of the heart respectively.

Viruses, including the SARS-CoV-2 virus that causes COVID-19, are the most common cause of myocarditis and pericarditis. Essentially, the inflammation the immune system generates to combat infections can inadvertently lead to inflammation of the heart.

In the very rare cases of myocarditis and pericarditis observed after vaccination with a COVID mRNA shot, it’s possible a similar thing might be happening. That is, the vaccine causes the immune system to generate some level of inflammation so it’s prepared to mount a response against SARS-CoV-2, and this inflammation is partially misdirected to the heart.

But the risk is very small, and the conditions are treatable.

A heart diagram with an inflamed pericardium (pericarditis) next to a heart with inflammation showing myocarditis.

Shutterstock

What’s the risk?

The exact incidence of myocarditis and pericarditis following vaccination is still being defined, and it remains to be proven that mRNA vaccines are truly the cause of these conditions — although it seems likely.

In Australia, of roughly 3.7 million doses of the Pfizer vaccine administered up to July 11, the Therapeutic Goods Administration (TGA) reports there have been 50 cases of suspected myocarditis or pericarditis. This suggests a risk of one per 74,000 vaccines. The TGA notes most people who developed these conditions have recovered or are recovering.

However, given the relatively small number of vaccinations administered in Australia, it’s important to consider more complete data from countries with higher vaccination rates.




Read more:
How rare are blood clots after the AstraZeneca vaccine? What should you look out for? And how are they treated?


The United States’ Centres for Disease Control and Prevention (CDC) had received 1,226 reports of myocarditis following 296 million doses of mRNA vaccines administered up to June 11. This equates to a risk of roughly one in 240,000 doses. These cases were mostly in young men and predominantly occurred after the second dose.

Independently from vaccines, myocarditis occurs in roughly 23 per 100,000 people worldwide per year (we don’t have reliable figures for pericarditis). This shows us there’s a much lower risk from vaccination than exists in the population generally.

Symptoms to look out for

Normal side effects of COVID-19 vaccines include headache, fever, chills, muscle or joint pain, fatigue and nausea.

In contrast, chest pain, irregular heartbeat, heart palpitations, shortness of breath and light-headedness could indicate myocarditis or pericarditis. Symptoms of these conditions have generally occurred within seven days of vaccination. Anyone who experiences these symptoms should seek medical attention.

In most cases, myocarditis and pericarditis can be successfully treated with anti-inflammatory drugs, such as aspirin and corticosteroids.

In Israel, 95% of cases recently investigated were classified as mild. Similarly, the CDC has reported most patients in the US have recovered quickly.

While this very small risk of heart inflammation following vaccination may be alarming, it’s crucial to understand the risk of heart damage following severe COVID-19 is far greater.




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Explainer: what is inflammation and how does it cause disease?


COVID-19 and heart damage

Damage of the heart muscle is a common consequence of coronavirus. Research shows it occurs in up to 28% of patients hospitalised with COVID-19.

Importantly, the risk of death is markedly higher in COVID-19 patients who sustain heart muscle damage. While we need further research to understand precisely how COVID-19 damages the heart, myocarditis and pericarditis are major causes of the heart damage found in COVID-19 patients.

The benefit outweighs the risk

The recent limits applied to the use of the AstraZeneca vaccine in younger age groups suggests the relatively low risk of COVID-19 in Australia justifies being highly selective over vaccine use.

But while Australia has done incredibly well at containing COVID-19, the risk of transmission here remains high given the global COVID-19 situation. We’re seeing this daily as we contend with outbreaks and lockdowns around the country.

Myocarditis and pericarditis are potentially associated with the mRNA vaccines, but these complications are extremely rare, most often mild, and seem to be treatable.

As has been the consistent message from the medical and scientific communities throughout this pandemic, the benefit of COVID-19 vaccines significantly outweighs the risk of rare side effects. This is particularly true for the highly effective mRNA-based vaccines as COVID-19 continues to spread around the world.




Read more:
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The Conversation


Jonathan Noonan, Research Officer, Atherothrombosis and Vascular Biology Laboratory, Baker Heart and Diabetes Institute and Karlheinz Peter, Interventional Cardiologist, Alfred Hospital; Professor of Medicine and Immunology, Monash University; Professor and Head, Department of Cardiometabolic Health, University of Melbourne; Lab Head, Atherothrombosis and Vascular Biology and Deputy Director, Baker Heart and Diabetes Institute

This article is republished from The Conversation under a Creative Commons license. Read the original article.

AstraZeneca advice has just changed (again). Here’s what you need to know if you’re in lockdown


Nicholas Wood, University of SydneySydney’s COVID outbreak has just prompted official advice on the AstraZeneca vaccine to change to encourage more people to get fully vaccinated sooner.

Now, the Australian Technical Advisory Group on Immunisation (ATAGI) recommends people in outbreak areas have their booster shot at 4-8 weeks after their initial dose rather than wait for 12 weeks. ATAGI now also advises people in outbreak areas under 60 to “re-assess the benefits to them and their contacts” from getting an AstraZeneca vaccine now if the Pfizer vaccine is not available.

Advice for people outside outbreak areas remains unchanged.

Here’s how to make sense of the latest advice if you’re in an outbreak area.

The situation has changed

Getting vaccinated, like taking any medication, is a case of balancing the risks against the benefits. And clearly, when there’s a COVID outbreak such as Sydney’s, the potential benefit of vaccination just increased.

We know two doses of AstraZeneca vaccine (or the Pfizer vaccine) are really good at preventing you from serious disease and hospitalisation. There’s growing evidence COVID vaccines also reduce your chance of infecting others. And we know two doses are needed to improve your protection from the Delta variant, which is currently circulating in NSW.




Read more:
Should I get my second AstraZeneca dose? Yes, it almost doubles your protection against Delta


Now let’s turn to the AstraZeneca vaccine. In parts of Australia with low rates of (or no) community transmission, the advice remains to wait 12 weeks after your initial dose for your booster shot. This is the time needed for your body to mount the best immune response.

However, as case numbers in Sydney have climbed, we’ve had calls from Prime Minister Scott Morrison, NSW Chief Health Officer Kerry Chant and Australia’s Chief Medical Officer Paul Kelly for people in outbreak areas to bring forward their AstraZeneca booster shots. Now ATAGI joins them.

Will I be protected if I go early?

Leaving less than 12 weeks between your first and second doses of AstraZeneca is a trade-off. There is slightly lower vaccine effectiveness against serious disease compared to if you’d waited for the full 12 weeks, but you will have some protection. In an outbreak, some reasonable protection now may be better than remaining unprotected while hanging out for greater immunity later.

The difficulty is pinning down exactly how much the vaccine’s efficacy drops by going early. The only figures we have that chart the different lengths of time between AstraZeneca shots and the corresponding levels of vaccine efficacy come from earlier variants of the virus (before Delta). We don’t actually have the figures as they relate to the Delta variant, circulating in NSW right now.

With that caveat in mind, here’s the best data we have about how different gaps between first and second dose of AstraZeneca affect its efficacy. It’s the same data ATAGI has cited to explain its latest advice.



The Lancet, CC BY-ND

If you’ve decided to go early with your booster shot, don’t worry if you can’t book an earlier appointment than 12 weeks. Your first shot has already started you on the protective road.




Read more:
Should I have my AstraZeneca booster shot at 8 weeks rather than 12? Here’s the evidence so you can decide


What if I’m under 60?

Earlier advice was for Pfizer to be the preferred vaccine for people under 60. This was due to an increased risk of the rare blood clot syndrome known as TTS (thrombosis with thrombocytopenia syndrome) associated with the AstraZenenca vaccine in this age group. This advice is still current for most parts of Australia.

But in outbreak areas, ATAGI now advises people under 60 to consider having the AstraZeneca shot now, if the Pfizer vaccine is not available. Again, in an outbreak, starting on your road to becoming fully vaccinated may be better than hanging on for a Pfizer shot, which may not arrive for a few months.

Yes, people under 60 are at increased risk of those rare clots compared to older age groups. But the risks are still small, and you should balance that with the potential benefits of vaccination during an outbreak.

Risk estimates of TTS are updated regularly as new cases are reported. The latest figures show if you’re under 60, your risk of TTS is 2.6 per 100,000 doses. If you’re aged 60 or over, the risk is 1.6 per 100,000 doses.




Read more:
Concerned about the latest AstraZeneca news? These 3 graphics help you make sense of the risk


Your GP or vaccine provider will also discuss what to look out for should you experience these rare blood clots. If you have symptoms including: a new severe and persistent headache (appearing a few days after the vaccine or one that does not improve after simple painkillers, and which may be accompanied by nausea and vomiting), abdominal pain, pin-prick bruising or bleeding, chest pain, leg swelling or trouble breathing in the few days to few weeks after the AstraZeneca vaccine, you will need to seek medical advice.

This could be due to the rare clotting syndrome and the earlier it is recognised the earlier it can be treated.

Common side-effects from the AstraZeneca vaccine include headache, muscle aches, fatigue, fever and pain or redness at the injection site. These usually start in the first 24-48 hours after vaccination and may last a few days. You can manage these with over-the-counter medicines for fever and pain, such as paracetamol.




Read more:
A history of blood clots is not usually any reason to avoid the AstraZeneca vaccine


One last thing to think about

If you are having trouble booking in at your local GP clinic, you can attend one of the NSW mass vaccination hubs, which may be out of your local government area.

Although you are permitted to leave the home for medical care (including vaccination), please only do so if you have no COVID symptoms, however mild.


The Conversation, CC BY-ND

The last thing we want to see is people spreading COVID while trying to get vaccinated, with the potentially devastating impact on health-care workers, clinics and the wider community.




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The symptoms of the Delta variant appear to differ from traditional COVID symptoms. Here’s what to look out for


The Conversation


Nicholas Wood, Associate Professor, Discipline of Childhood and Adolescent Health, University of Sydney

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Should I have my AstraZeneca booster shot at 8 weeks rather than 12? Here’s the evidence so you can decide


from www.shutterstock.com

Nathan Bartlett, University of NewcastlePrime Minister Scott Morrison appeared to have made a “captain’s call” yesterday by encouraging people in New South Wales outbreak areas to have their AstraZeneca booster closer to eight weeks after their initial shot rather than wait for the generally recommended 12 weeks.

We would be encouraging the eight to 12-week second dose be done at the earlier part of that period […]. That is consistent with medical advice […] and given the risks to people from the outbreak in that area we believe it is important they get that second dose of AstraZeneca as soon as possible.

The official health advice from ATAGI, the Australian Technical Advisory Group on Immunisation, remains most people have their booster shot at 12 weeks for optimal COVID protection, but under certain circumstances that can go down to four weeks. Those circumstances include imminent travel or if there’s a risk of COVID-19 exposure.

ATAGI’s concern, and that of some other vaccine experts, is if you have your booster shot earlier than 12 weeks, your body won’t develop enough immunity to reliably protect you from serious disease.

Confused? Here is what we know so far.

What’s the official advice?

The evidence underpinning the recommended 12 week gap between the first and second AstraZeneca shots comes from a study published in the Lancet.

The study found leaving less than six weeks between the initial shot and the booster gave 55.1% efficacy (protection from symptomatic disease). Leaving 6-8 weeks between shots increased efficacy to 59.9%, and waiting 9-11 weeks, efficacy was 63.7%. However, if the gap was 12 weeks or longer efficacy jumped to 81.3%.

So to get the best protection from the AstraZeneca vaccine, you need at least 12 weeks between your first and second shot.


The Conversation (adapted from Vaccine Immunology, Plotkin’s Vaccines [Seventh Edition] 2018), CC BY-ND

Now we find ourselves with an active outbreak of the highly transmissible Delta variant of SARS-CoV-2 in Sydney. So we need to ask ourselves whether aiming for the highest level of protection is best, or whether we need to aim for a reasonable level of immunity as quickly as possible.

The Lancet paper didn’t include data on the Delta variant as it wasn’t widely circulating at the time, but this is fast becoming the dominant variant globally.

Yet we do know two doses of the AstraZeneca vaccine protects against serious COVID-19 after infection with the Delta variant, whereas one dose doesn’t.




Read more:
Should I get my second AstraZeneca dose? Yes, it almost doubles your protection against Delta


What’s the evidence for 8 weeks to protect against Delta?

Morrison’s call for some people to have their AstraZeneca booster shot from around eight weeks hasn’t come completely out of the blue. It’s an approach the UK has been using to get ahead of the infectious Delta variant, the same variant circulating in NSW.

We know leaving less time between AstraZeneca shots generally reduces vaccine efficacy. But what about that in the context of the Delta variant? This is where things get a bit tricky if we actually want to put a figure on precisely how much vaccine efficacy reduces.

A study published in Nature reported a single dose of AstraZeneca vaccine induced essentially no Delta virus-neutralising antibodies.

However, two doses induced a neutralising antibody response in 95% of people, albeit at a significantly lower level than with the Alpha variant (which originated in the UK).

Still, neutralising antibodies against Delta were there in the vast majority of people after two shots, antibodies that could mean the difference between a mild illness and hospitalisation with severe disease.

There are some limitations with this study. First, it did not directly assess vaccine efficacy (you need to conduct a clinical trial for that). Second, it used a range of intervals between first and second shots, so we cannot definitively say the precise protection from the Delta strain at eight weeks versus 12 weeks.

However, assessing the capacity of vaccinated peoples’ antibodies to neutralise viruses in the lab is a good indicator of the quality of vaccine-induced protection — and this study really highlighted the need for a booster shot for protection against the Delta variant.




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The symptoms of the Delta variant appear to differ from traditional COVID symptoms. Here’s what to look out for


So with infection numbers in Sydney looking more ominous by the day, coupled with the knowledge one vaccine dose is all but useless against the Delta virus, it is clear getting two doses into the arms of as many people as possible as quickly as possible, is the strategy.

Two doses, even at eight weeks apart, while not providing the highest possible level of protection, will still protect many from severe disease.

What else do I need to think about?

A drop in immunity is not the only thing to consider when weighing up the pros and cons of having your AstraZeneca booster shot early.

We’ve just heard more Pfizer shots are on their way sooner than expected. If a Pfizer booster shot is made available to people who have already had two shots of AstraZeneca (and this is a big if), this could be a game changer.

In this case — and remember this mix-and-match approach has not been officially sanctioned — it might not matter too much if an early second dose of the AstraZeneca vaccine gives you sub-optimal immunity. The Pfizer booster would lift your immunity instead.

However, it remains to be seen whether such a major policy shift would happen in time to protect people currently in lockdown in NSW.

Take-home message

The Delta variant is highly transmissible. So weeks do matter, and with Australia still heavily reliant on the AstraZeneca vaccine, for now it does makes sense to reduce the time between the first and second jab.

This is clearly preferable to remaining unprotected for an extra month, particularly if you are at higher risk of infection and/or severe disease.The Conversation

Nathan Bartlett, Associate Professor, School of Biomedical Sciences and Pharmacy, University of Newcastle

This article is republished from The Conversation under a Creative Commons license. Read the original article.

How can younger Australians decide about the AstraZeneca vaccine? A GP explains


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Brett Montgomery, The University of Western AustraliaIt has been a wild week for public messaging about the AstraZeneca COVID-19 vaccine — baffling both for the public and for general practitioners like me.

Just over two weeks ago, the Australian Technical Advisory Group on Immunisation (ATAGI) advised the AstraZeneca vaccine was now preferred only for people over 60. The Pfizer vaccine was encouraged in those under 60, but this isn’t yet widely available.




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Australians under 60 will no longer receive the AstraZeneca vaccine. So what’s changed?


Prime Minister Scott Morrison sparked a controversy on Monday, saying ATAGI’s advice did not prohibit the vaccine in younger people. He invited people under 60 to chat to their GPs about it. This was reported as a “massive change” to the vaccine program.

His comments were rebuked by health officers and premiers.

Meanwhile, Health Minister Greg Hunt explained there had been “no change” to the medical advice.

For many, these disagreements were confusing.

Hunt is right, though: the ATAGI advice has remained the same since mid-June. The advice is careful and nuanced:

COVID-19 Vaccine AstraZeneca can be used in adults aged under 60 years for whom Comirnaty [Pfizer] is not available, the benefits are likely to outweigh the risks for that individual and the person has made an informed decision based on an understanding of the risks and benefits.

Let’s dig into this sentence’s subtleties, and try to shed light rather than heat on the issue.

Three principles for decision-making

ATAGI’s sentence above contains three principles, all of which should be true if the AstraZeneca vaccine is to be used in a person under 60.

First, the Pfizer vaccine should be unavailable. This is the case for many people at the moment. Anecdotally, I’m told of waits of about three months for the Pfizer, if you can get an appointment at all. A surge in availability is promised, but not until October.

Second, the benefits of the AstraZeneca vaccine should outweigh the risks. This is tough, as risks and benefits can be hard to estimate.

The major (and well-known) risk of the AstraZeneca vaccine is an unusual clotting syndrome, which is rare, treatable, but sometimes fatal.




Read more:
How rare are blood clots after the AstraZeneca vaccine? What should you look out for? And how are they treated?


The benefits include prevention of COVID and its consequences, including hospitalisation and death.

The balance between risks and benefits depends on the person’s risk of being exposed to COVID (which might vary based on travel or occupation) and on their risk of bad outcomes (like death) should they get COVID.

Age seems the most important risk factor for these terrible outcomes, but other conditions appear important too, including heart disease, lung disease, high blood pressure, diabetes and cancer. (Though people under 60 with these conditions are eligible for Pfizer, at present they may be kept waiting.)

The risk of virus exposure depends greatly on how much COVID is present in our community. The less there is about, the less likely you’ll catch it. But this can change quickly and unpredictably, adding difficulty to decisions.

Third, the person receiving the vaccine needs to give their informed consent based on an understanding of these risks and benefits.

To give informed consent, you need to understand the risks and benefits.
CDC/Unsplash

Informed consent

Handy decision aids help visualise some, but not all, of these risks. For example, this figure shows the trade-off between risks and benefits during a relatively mild outbreak, equivalent to Australia’s first COVID wave.


Screenshot from health.gov.au

In this setting, the benefits of vaccination don’t clearly outweigh the risks until people are over the age of 60. This is why ATAGI has used 60 as an age threshold for using the AstraZeneca vaccine.

But if we had a severe outbreak, like in Europe last winter, the benefits of the vaccine would easily outweigh the risks, even in people from the age of 30.


Screenshot from health.gov.au

Individual decisions

These charts are helpful for thinking about how age and disease prevalence affect decisions. But they don’t include all relevant facts. For this, a discussion with a GP could be helpful — ideally a GP who knows you well.

ATAGI’s co-chair Christopher Blyth has recently clarified the AstraZeneca vaccine should only be used under 60 in “pressing” circumstances.

I can imagine such circumstances. For example, consider a 59 year-old with diabetes and heart disease who plans to travel to a country with many COVID cases. Here, I’d feel confident the benefits outweigh the risks.

However, imagine a 25 year-old with no underlying medical conditions, not travelling, and not working in a high-risk profession. Compared to the previous example, risks are similar, but benefits are fewer. It’d be hard to convince myself the benefits would outweigh the harms here — at least not while our COVID case numbers remain low.




Read more:
Under-40s can ask their GP for an AstraZeneca shot. What’s changed? What are the risks? Are there benefits?


However, our case numbers are unlikely to stay low forever and if we wait for a big outbreak before vaccinating, immunity may arrive too late.

These are fraught decisions, full of ethical tensions. I want to respect my patient’s autonomy — and there’s a part of me that feels I should be able to vaccinate anyone if they are informed and want the vaccine. After all, many people take other, bigger risks elsewhere in their life.

And it’s admirable many younger Australians seeking vaccination are doing so not just for themselves but also to protect their community. But balanced with this, we need to try to minimise harm.

A gloved hand holds an AstraZeneca vial.
The risks are small but real, and need to be balanced with the benefits.
Shutterstock

Under 60 and still keen for a vaccine?

If you want to be vaccinated and are under 60, and Pfizer is unavailable, you could speak to your GP — especially if your circumstances put you at special risk.

I think it is best to do this in a special consultation rather than squeezing it into an immunisation clinic time slot. Because our vaccines come in multidose vials, most practices run quite rapid-fire vaccination clinics, allowing only a few minutes for each person. Such clinics are workable for uncontroversial vaccine decisions in people over 60, but mightn’t allow enough time for complex decisions with younger people.

By working with your GP, I hope you’ll feel you can arrive at the decision best suited to your circumstances and values.The Conversation

Brett Montgomery, Senior Lecturer in General Practice, The University of Western Australia

This article is republished from The Conversation under a Creative Commons license. Read the original article.

View from The Hill: Scott Morrison’s AstraZeneca ‘hand grenade’ turns into cluster bomb


Michelle Grattan, University of CanberraThe debate about the vexed vaccination rollout on Wednesday exploded into an extraordinary free-for-all, with Prime Minister Scott Morrison under fire and health experts arguing among themselves.

Morrison had hoped by easing the way for younger people to get AstraZeneca he’d give a push to the program’s slow pace; equally, he wanted to put to use the excess supply of a vaccine that’s become unpopular in the public marketplace.

But his Monday night comments after national cabinet did not sit easily with the advice of the Australian Technical Advisory Group on Immunisation.

ATAGI says Pfizer is the preferred vaccine for people under 60. When it comes to AstraZeneca, it has not given an actual no-no for younger people – seeing it as an alternative when Pfizer’s not available and there’s informed consent – but has discouraged its use.

Former health department secretary Jane Halton makes the distinction between population-wide advice – about those over and under 60 – and what may be best for individuals based on their own circumstances. AstraZeneca has been registered in Australia to be given to anyone over 18, she points out.

Instead of advancing the rollout, Morrison’s intervention triggered one of the worst days he’s had among many bad ones on vaccine issues.

There’s confusion and anger, when what’s required is order and calm. We heard the sort of cacophony more usual in the middle of an election campaign.

The government insists Morrison’s words did not contradict ATAGI.




Read more:
View from The Hill: No, this isn’t based on the medical advice


Phil Gaetjens, secretary of the Department of Prime Minister and Cabinet, told his state counterparts on Tuesday there was no inconsistency between what the PM had said and the clinical advice (and blamed some media coverage).

But the critics saw considerable inconsistency.

First to Morrison’s Monday words.

He said: “The ATAGI advice talks about a preference for AstraZeneca […] for those over 60. But the advice does not preclude persons under 60 from getting the AstraZeneca vaccine.

“And so if you wish to get the AstraZeneca vaccine, then we would encourage you to go and have that discussion with your GP.” The government would establish an indemnity scheme to protect the doctors.

In its formal statement, national cabinet “noted” the indemnity scheme and also “noted that GPs can continue to administer AstraZeneca to Australians under 60 years of age with informed consent”.

Queensland Premier Annastacia Palaszczuk on Wednesday was adamant there had been “no national cabinet decision about AstraZeneca being given to under 40s.” (They are the ones not being vaccinated at the moment.)

She wanted to know if the federal cabinet had made the decision.

Her “message to Queenslanders” was to listen to the Queensland Chief Health Officer Jeannette Young and other health experts on the vaccine.

Young – who is Queensland’s governor-in-waiting – absolutely let fly.

“No, I do not want under 40s to get AstraZeneca,” she said. “It is rare, but they are at increased risk of getting the rare clotting syndrome.

“We’ve seen up to 49 deaths in the UK from that syndrome. I don’t want an 18-year-old in Queensland dying from a clotting illness who, if they got Covid, probably wouldn’t die.”

Former federal deputy chief medical officer Nick Coatsworth had earlier tweeted: “Critical ethical principle of autonomy at stake here. Should not be paternalistic. Adults should be allowed to consent to an intervention with a 3 in 100,000 risk of thrombosis with thrombocytopenia syndrome and less than 1 in 1,000,000 of death”.

Coatsworth – the guy you see in those Commonwealth vaccination advertisements – added after Young’s comments, “Well, I guess that puts me at odds with the QLD CHO”.

Charlotte Hespe, from the Royal Australian College of General Practitioners, described Young’s comments as scaremongering.

Western Australia Premier Mark McGowan said the Commonwealth had made a decision to allow younger people to be able to receive AstraZeneca and “provided an indemnity for GPs who do that. The health advice we have is that they shouldn’t”.

As McGowan observed, “with health advice, lots of doctors give you different advice at different points in time”.

And, indeed, see things differently from day to day.




Read more:
View from The Hill: No, this isn’t based on the medical advice


Australian Medical Association President Omar Khorshid on Tuesday declared Morrison’s announcement “a really significant change in the vaccine program”.

On Wednesday, he said: “The PM simply removed the age restrictions on AZ.”

But Khorshid did say Morrison had thrown a “hand grenade” into the rollout. “Today shows why we need to keep the politicians out of health discussions, and leave them between patients and their doctors.”

While the argument raged about AstraZeneca, problems just deepened over the shortage of Pfizer.

Queensland Health Minister Yvette D’Ath said the state had written to Lieutenant General JJ Frewen, who is in charge of the rollout, to ask for further supplies.

“The reason we gave is that we are at a critical level and that at some of our sites we are projected to run out of Pfizer by as soon as … next Monday.

“We sent that letter yesterday. We got a response this morning. From the lieutenant general. We’ve been advised that we will not be provided additional vaccines of Pfizer.”

Queensland did not suggest which state or territory should get less Pfizer to meet its request for more.

National cabinet meets again on Friday. With frustrations high, tempers frayed, and some states struggling with their own shortcomings, its effectiveness will be tested to the limit.The Conversation

Michelle Grattan, Professorial Fellow, University of Canberra

This article is republished from The Conversation under a Creative Commons license. Read the original article.