How experts convinced me not to get the AstraZeneca shot
Medical experts have convinced me to avoid the AstraZeneca jab. This is unfortunate because widespread hesitancy about taking the AstraZeneca vaccine means that millions of Australians continue to be at risk of being infected with coronavirus (COVID19).
Concerns about side-effects top the list of reasons for vaccine hesitancy according to a recent survey by research company Resolve Strategic. Almost one-third of adult Australians surveyed say they are unlikely to be vaccinated.
The finding poses a major roadblock to the reopening of the economy and a path back to the way we lived before the pandemic.
Questions about the efficacy of the AstraZeneneca vaccine undermine confidence
Questions about the efficacy of the AstraZeneneca vaccine, which is the cornerstone of Australia’s vaccine rollout, have also undermined public confidence.
In March US health officials said AstraZeneca may have included ‘outdated information’ in a coronavirus vaccine trial.
In an extraordinary rebuke, just hours after AstraZeneca announced its vaccine worked well in a US study, an independent panel overseeing the study scolded the company for cherry-picking data.
The panel wrote to AstraZeneca and US health leaders that it was concerned the company chose to use data that was outdated and potentially misleading instead of the most recent and complete findings, according a panel member.
Despite some concerns over the strength of scientific data on the AstraZeneca vaccine, many experts backed its approval by the Therapeutic Goods Administration (TGA), Australia’s medical regulator.
In its detailed analysis, the TGA said AstraZeneca was shown to be safe and prevent COVID-19, the disease caused by the coronavirus, but it was not clear whether it prevented transmission or asymptomatic disease.
Despite the green light, there were other issues raised by the TGA.
In its report, the regulator raised “significant concerns” about the robustness of the data used in the company’s trials and said there was “insufficient data” about the dosing of the vaccine.
Vaccine expert Tony Cunningham, from Sydney’s Westmead Institute, said he was “pleased” the TGA had raised those concerns.
Professor Cunningham said while it was abundantly clear the vaccine was safe and provided a “strong immune response”, he said the number of trials running in tandem across different countries had provided “bitsy data” from different places.
The AstraZeneca vaccine first came under the spotlight last year after a mistake in its dosing regime showed different efficacy rates — ranging from 62 per cent to 90 per cent — depending on the trial and the dose given.
Despite this AstraZeneca announced that its COVID-19 vaccine was “highly effective” in preventing disease.
Researchers found that if people were given a half dose followed by a full dose of the vaccine, rather than two full doses, about 90 per cent of people were protected.
Where two full doses were given at least one month apart it showed 62 per cent efficacy.
The combined average across different dosing regimes, which had a total of 11,636 trial participants, was 70 per cent effective.
At first glance the results were lauded. The Australian Government declared it a “very good result” that will help create a “fully safe Australia”.
But Geoff Porges wasn’t convinced. Dr Porges, is a vaccine expert of 25 years and a director of therapeutics research at one of the world’s leading healthcare investment banks.
Dr Porges said he thought AstraZeneca had “embellished the data”. Pressure quickly mounted on the company when a stream of other scientists and researchers across the world agreed with Dr Porges’ initial assessment.
Some labelled it “shaky science”, while others questioned the legitimacy of the data released by the company.
By contrast, the coronavirus vaccines made by Moderna and Pfizer-BioNTech have proven to be highly effective at preventing symptomatic and asymptomatic infections under real-world conditions.
Consistent with clinical trial data, a two-dose regimen prevented 90 percent of infections by two weeks after the second shot. One dose prevented 80 percent of infections two weeks after vaccination.
Rare blood clotting syndrome linked to the AstraZeneca vaccine
Then, in early March, news came that the AstraZeneca vaccine rollout was being suspended in Germany, Italy, France and Spain amid blood clot concerns.
The World Health Organization appealed to countries not to suspend vaccinations against COVID, which had caused more than 2.7 million deaths worldwide to that point.
“As of today, there is no evidence that the incidents are caused by the vaccine and it is important that vaccination campaigns continue so that we can save lives and stem severe disease from the virus,” WHO spokesman Christian Lindmeier said.
Australia’s medical regulator had approved the AstraZeneca coronavirus vaccine for use in Australia on February 17 and by mid March Australia had secured 53.8 million doses of the AstraZeneca vaccine, 50 million of which were to be made in Australia by medical giant CSL.
On March 12 Prime Minister Scott Morrison said Australian health authorities had not raised any concerns about using the AstraZeneca vaccine and that there was no advice to pause Australia’s rollout.
On the same day news came that Denmark, Norway and Iceland had suspended the use of the AstraZeneca vaccine, following reports that people who received it went on to form blood clots.
Deputy Prime Minister Michael McCormack also sought to assure Australians the vaccine remained safe to use.
“We’re getting on with the vaccine, we’re getting on with the rollout, and Australians should be assured our TGA — which is world class — they’ve said it’s OK,” he said.
In a statement, Chief Medical Officer Paul Kelly said there was no evidence to suggest the vaccine caused blood clots.
“Safety is our first priority and in a large vaccine rollout like this, we need to monitor carefully for any unusual events so we will find them,” he said.
“This does not mean that every event following a vaccination is caused by the vaccine. But we do take them seriously and investigate — and that’s what Denmark is currently doing.”
On April 3 Queensland’s Chief Health Officer Jeannette Young said, “all vaccines have some very, very rare side effects”.
“At this point in time, people shouldn’t be concerned and we expect rare side effects,” Dr Young said. “We just need to be aware of them and individuals need to be aware of them.”
Her comments followed the case of a 44-year-old man who was being treated at Melbourne’s Box Hill Hospital after being admitted with serious thrombosis and a low platelet count.
The man had received a dose of the AstraZeneca vaccine nearly two weeks earlier. His symptoms appeared to fit the diagnostic criteria for vaccine-induced pro-thrombotic thrombocytopenia.
The case was being investigated by the Therapeutic Goods Administration (TGA), the Australian Technical Advisory Group on Immunisation (ATAGI) and the Australian Health Protection Principal Committee (AHPPC).
Commenting on the case of the 44-year-old man, Dr Nada Hamad, a member of the Haematology Society of Australia and New Zealand, said while information was still being gathered it had “intrigued the medical community enough to want to understand this process, and to try and figure out how to minimise it”.
“I think what’s important is that people not panic,” Dr Hamad said.
Then, on April 29, it was reported that two men had died days after receiving the AstraZeneca vaccine in New South Wales, with reviews underway to determine whether the jab contributed to their deaths.
One man, reportedly in his 50s, died at a hospital in Tamworth in the state’s northwest. The other man, believed to be in his 70s, had died in Sydney.
AstraZeneca COVID vaccine no longer recommended for people under 50
Three weeks later, on April 8, Prime Minister Scott Morrison announced that the AstraZeneca COVID vaccine would no longer be recommended for people under 50 based on the risk of developing the rare clots.
Instead, Pfizer was now the preferred vaccine for people under 50 in Australia. This change was based on advice from the Australian Technical Advisory Group on Immunisation (ATAGI).
Professor Allen Cheng, who co-chairs ATAGI said his committee, and others, had to weigh up the risks.
“We think the risk in younger people is probably around the order of two to four per 100,000,” he said. “That’s a pretty small risk still but it’s starting to get into the territory where we think that is starting to outweigh the benefit.”
On May 6 five new cases of the clotting disorder were confirmed by the Therapeutic Goods Administration (TGA): two cases were women, aged 51 and 64, and three were men aged 66, 70 and 74.
By that stage 11 Australian cases of the rare blood clotting phenomenon known as thrombosis with thrombocytopenia syndrome (TTS) had occurred in people following vaccination with the AstraZeneca vaccine.
The 66-year-old man was in intensive care in Townsville with thrombosis after receiving his first AstraZeneca dose on March 30, and the 70-year-old man was in a stable condition in hospital in Tasmania.
TGA head Adjunct Professor John Skerritt said he was “not surprised” that five new cases of a rare blood clotting syndrome linked to the AstraZeneca COVID-19 vaccine had been identified in Australia.
“This is a rare adverse event but we believe it’s staying at the expected frequency and at the frequency that we’re seeing internationally,” he said.
Like other talking heads, Professor Skerritt was trying to assure Australians that while the AstraZeneca vaccine was recommended as safe for people over 50, the sometimes fatal clotting reaction was not unheard of in people in that age group in trials and elsewhere around the world.
But in seeking to reassure us that the odds of suffering a potentially fatal clotting reaction are rare, Professor Skerritt only convinced me not to get the AstraZeneca shot.
“If you step back and think about who is now getting the AstraZeneca vaccine, it is, with a few rare exceptions, only people over 50,” he said.
“So it is obvious that future cases will be in the over 50s.
“The early results globally showed that the prevalence of this rare side effect was much more common in people under 50, but it wasn’t unknown in people over 50.
“So we’re not surprised with the results.”
Whether Skerritt realised his own-goal isn’t clear but when I looked into his credentials, I was even less assured by his pontifications about the safety of AstraZeneca.
Skerritt is not a medical doctor. He is not a haematologist. He is not a public health expert or epidemiologist. He’s not a virologist. Indeed, he’s not a practising clinician or researcher of any kind. He’s a PhD in pharmacology who has spent decades on government boards and committees.
Another chap who gave me pause is the Royal Australian College of General Practitioners Rural Chair and Townsville GP, Dr Michael Clements.
Dr Clements spoke to the ABC about the clotting complication in a 66-year-old Townsville man, one of the five newer cases of blood clotting believed to be linked to the AstraZeneca vaccine.
The Townsville man received the first dose of the vaccine on March 30 and developed abdominal pain before presenting to the Townsville University Hospital.
He was later admitted to the Intensive Care Unit with thrombosis.
Dr Clements said the case was saddening.
“I’m sure this person and their family didn’t want this to happen,” he said. “Nobody wants to go to ICU after doing what has been recommended by the public health.”
Dr Clements said he was concerned the Townsville case would prevent people over the age of 50, who were now eligible for the AstraZeneca vaccine, from getting the jab.
“From a science point of view, we knew this would happen,” he said.
“If we vaccinate enough people, the evidence tells us that there’ll be a number of them who do get this reaction.
Another own-goal, this time from a medico, although like Dr Skerritt, Dr Clements has no training or expertise in public health or epidemiology and no specialist medical training in virology or haematology.
Despite these deficits, Dr Clements does have a nose for which way the wind is blowing.
“Sadly, I think, for those who were hesitant to start with, this case is going to be something that they’re going to add into their list of reasons why not to have the vaccine.”
Dead right.
Given the almost zero prevalence of COVID19 in the Australian community, I am not going to put myself in harm’s way, no matter how rare such an event may be. I have one life and it is too precious.
Pfizer to the rescue for over 50s
On May 19 the federal government made a muted concession that the COVID vaccine rollout was being impeded by vaccine hesitancy, particularly in regard to AstraZeneca.
Health Minister Greg Hunt said people over the age of 50 who were currently eligible for the AstraZeneca vaccine could instead wait for Pfizer or Moderna doses.
On May 25, the federal government promised that two million Pfizer doses each week would be available from the start of October, although Health Minister Greg Hunt reiterated “people should not wait” and should get vaccinated now.
Amid reports some over 50s are waiting to receive a different vaccine, Mr Hunt has urged all people eligible for a vaccine to get a jab as soon as possible.
“If you are in a qualifying group, if you are in the over 50s, please come forward now,” he said. “Vaccination will save lives and protect lives, and if you aren’t vaccinated and you do catch COVID you could die. It’s as simple as that.”
This echoed comments from the vice-president of the Australian Medical Association, Chris Moy, who said he was worried too many Australians felt safe from the virus to the point where they were not motivated to get their vaccine when they became eligible.
He’s half right. I feel relatively safe (not complacently so) but mostly I am scared of the potentially fatal clotting complications linked with AstraZeneca. Messaging from experts and MPs that ignores these legitimate fears will only fall on deaf ears.
Why so? Two reasons.
First, most patients accept that medicines have side effects and that this is the trade of between being sick and getting better. However, this trade off doesn’t work in the same way when healthy people are asked to take a medicine (AstraZeneca vaccine) that has rare and fatal side effects in return for preventing a rare and fatal infection (COVID).
Now that the government has promised a failsafe alternative in the form of the Pfizer vaccine, can cautious people like me be blamed for saying no to AstraZeneca and waiting until October?
Second, despite comments from some experts that unvaccinated Australians are “sitting ducks” (only four per cent of Australians are fully vaccinated), the prevalence of coronavirus in Australia is virtually zero at the time of writing.
This is because the federal government is keeping Australia’s international borders firmly shut, despite calls to begin reopening the border and our globally-linked economy.
Prime Minister Scott Morrison won’t be opening the border until after the next federal election, which could be held as late as May 2022. The PM has seen the polling that shows Australians largely approve of tight border controls, which make us feel safe from the ravages of the COVID pandemic. He has also seen thumping victories by incumbent state governments in Western Australia and Queensland — governments that have been tough on border control.
As to the alarmist claim that unvaccinated people are “sitting ducks”, let’s not forget that Australia has achieved low community transmission because it has employed standard public health measures in response to the pandemic — namely social distancing, hand washing, mask-wearing, contact tracing, quarantining, and periodic shut downs — all this long before the arrival of vaccines.
Indeed, modelling provided to National Cabinet on 3 August this year revealed that it will be public health measures that do the heavy lifting of keeping the delta variant and its mutants at bay.
The graphic below shows that as effective as vaccinations will be, at best they will contribute only 40 per cent of the national defence against the contagious delta variant.
Experts suggest raising age limit for AZ to 60+
On June 10, The TGA revealed Australia’s second death from TTS due to the AstraZeneca vaccine. The death occurred in a 52 year old woman who suffered a catastrophic stroke. As of early June there have been 35 definite TTS cases and 13 probable ones linked to the vaccine. Most are recovering but 15 are still in hospital, including one in intensive care.
The incidence of TTS linked to AstraZeneca remains low: in people under 50 it is 3.2 cases per 100,000 and in people over 50 it is 1.8 per 100,000. The death rate among people who suffer TTS linked to AstraZeneca is 3–4 per cent. The majority of cases in Australia are of a less serious and more treatable type.
Of the total 48 cases about 30 percent fall into the severe end of the condition, and this is where age becomes a factor. According to overseas data, the younger the person receiving AZ, the more likely they are to develop TTS and the more likely they are to develop a serious disease, and this severity risk appears to extend into the 50 to 59 age bracket.
Some Australian experts are now arguing for a change, given the latest data. “Personally, I do have concerns about looking very carefully at needing to move the age up to 60,” said Professor Huyan Tran, a respected haematologist at the Royal Prince Alfred Hospital in Melbourne.
His concerns are echoed by Associate Professor Margie Dancin, a paediatrician from the Royal Children’s Hospital who researches people’s perception of vaccine risk. “It may be time to consider now that we do offer the Pfizer vaccine for the 50 to 59 age group,” she said.
Age limit for AZ raised from 50 to 60 in Australia
On June 17, Australian health authories raised the age limit for people given the AZ COVID-19 vaccine to 60 years and older. The decision followed an additional 12 cases of the clotting syndrome in early June.
Pfizer will be made available for anyone aged 40 to 59 at federally run vaccination clinics. The latest advice affects 2.1 million additionL people aged between 50 and 59.
This change will further slow the rollout, add pressure on the delivery of Pfizer doses from overseas, and cause further vaccine hesitancy related to side effects of COVID vaccines.
This second policy shift on AstraZeneca in the past two months confirms increasing evidence that the AstraZeneca vaccine is not the safe and effective shield against COVID that it was promised to be, despite initial and continuing claims that it is.
It also sends mixed messages to different segments of the community. Older Australians — those aged 60 and over — are being asked to have a vaccine (AstraZeneca) that is not as good as the Pfizer vaccine so that younger people can have it instead.
The problem is that the federal government is not saying this, which leaves a communication vacuum to be filled with misinformation and rumour. The nation’s pubic health cannot afford this at a time when so many people are still unvaccinated and the threat of the Delta variant is a daily threat to the status quo.
Also, the fact that a further two million Pfizer doses each week will be available from October means that many Australians will wait for that option, further delaying the prospect of herd immunity. This is a dangerous mix that implies no urgency.
PM creates chaos by saying anyone under 40 can approach their GP and request the AstraZeneca
By far the most contentious advice to be issued about the AstraZeneca vaccine came when Prime Minister Scott Morrison announced a massive change to Australia’s coronavirus vaccination program, advising that anyone under the age of 40 could approach their GP and request the AstraZeneca vaccine.
The advice of the nation’s peak advisory group to government on COVID vaccines is The Australian Technical Advisory Group, which says Pfizer is the recommended vaccine for Australians under the age of 60 due to the risk of rare blood clotting disorders linked to the vaccine in younger people.
The unilateral announcement by the PM was met with howls of condemnation by state premiers and their chief health officers and widespread confusion in the community. It also added new demand for dwindling supplies of the Pfizer vaccine at a time when 12 million Australians have been locked down to protect them from new outbreaks of the virus across the nation.
The new advice caught GPs unprepared and unable to advise patients about their individual risks since there are no known risk factors for blood clotting condition beyond age. This is because researchers have not been able to identify the mechanism(s) of action that produce thrombosis with thrombocytopenia syndrome (TTS).
Bungled and disingenuous messaging by the federal government about the safety, efficacy and availability of vaccines has cemented my decision not to be vaccinated with AstraZeneca, which has rare but serious side effects. No amount of positive spin from talking heads in government can convince me otherwise.
Instead, I’ve been guided by the scientific evidence presented by relevant experts that the AZ vaccine is linked to serious adverse health outcomes. As an immunocompromised 58 year old this puts me and others in a precarious situation. Fortunately, I am now due to get the Pfizer jab on July 1 and a second jab three weeks later. Meanwhile, 2021 is still the year of living dangerously.
Dan Gaffney MPH is a teacher and author. His book and podcast series, Journey Home — Essays on Living and Dying was published in 2019.
