Matters of Communication: Handelsblatting the Oxford-AstraZeneca Vaccine
The Oxford-AstraZeneca COVID-19 vaccine is fast becoming a subject of notoriety. First, will States obtain it? Second, will they use it? The first answer has generally been affirmative, given the vaccine’s ease of storage and relative cheapness. The second is becoming increasingly difficult.
Orders have been made and supplies – some of them anyway – furnished, but vials and batches are not being used. Countries are either restricting or suspending the jab. AstraZeneca finds itself mounting what can only be a round-the-clock communications battle trying to dissuade officials not to put the brakes on.
Various artillery pieces have been marshalled against it. In late January, French President Emmanuel Macron expressed disappointment with the vaccine a mere few hours before the European Medicines Agency (EMA) approved its use on all adults. “The real problem on AstraZeneca is that it doesn’t work the way we were expecting it to,” he told press members. “We’re waiting for the EMA results, but today everything points to thinking it is quasi-effective on people older than 65, some say those 60 years or older.”
Even before any rollout, the vaccine’s name was already being blackened, if not smudged. The EMA’s words of approval (“as there is reliable information on safety in this population, EMA’s scientific experts considered that the vaccine can be used in older adults”) seemed lost in the noisy scepticism being promoted by such outlets as the Handelsblatt. In late January this year, the finance paper claimed that the vaccine “apparently has an effectiveness of only 8% in the elderly,” an assertion drawn from an “anonymous government source.” A follow-up story did not allay any doubts, with the paper insisting it had the words of an unnamed health ministry bureaucrat. “Confusion is out of the question. According to data available to us so far, effectiveness in people over 60 is less than 10%.”
The falseness of the claim did little to trouble the paper’s political correspondent, Gregor Waschinski. “I understand that some would like to see the story substantiated with actual data,” he tweeted. “However, this is not an academic preprint but a sourced piece of political reporting.” This reduction of scientific accuracy to political, sloppy expediency prompted Markus Lehmkuhl, a science communications academic based at the Karlsruhe Institute of Technology, to despair. “Precise scientific information” had been attributed to one “unsuitable source, who, to make matters worse, did not want to be quoted by name.”
Recommendations from various countries advocating not using AstraZeneca’s vaccine for the elderly subsequently proliferated. STIKO, the German Standing Committee on Vaccination, was quick in recommending against using the vaccine for those aged 65 and over. The Committee head, Thomas Mertens, tried to clear the air of confusion induced by the Handelsblatt’s reporting. The recommendation was “not about critique of the vaccine, but of the lack of data,” he told the BMJ. “When there is more and better data, STIKO will change its recommendation.”
France followed. “This recommendation will be re-examined in the light of availability of additional data,” promised France’s national health authority HAS. Sweden’s Public Health Agency also revealed it was waiting for data “from an ongoing and large US clinical trial in Phase 3” that “will include a sufficient number of older participants to be able to draw more certain conclusions regarding the protective effort.”
In South Africa, a more drastic step was taken. Use of the Oxford-AstraZeneca vaccine was totally suspended, with fears about efficacy, notably against the South African COVID-19 variant. The February 10 announcement from the Health Minister Zweli Mkhize showed a tilting of the government towards the Johnson & Johnson candidate. “Given the outcome of the efficacy studies [the government] will continue with the planned phase one vaccination using the Johnson & Johnson vaccines instead of the AstraZeneca vaccine.”
The latest round of concerns centre on whether the vaccine, or certain batches of it, have encouraged the forming of blood clots. Italy’s medicines authority AIFA took what it called a “precautionary” measure to ban the ABV2856 batch after the deaths of two men in Sicily following inoculation. The agency added that no link had yet been established between the vaccine and subsequent “serious adverse events.” Austria’s own decision to suspend use was directed at the company’s ABV5300 batch after a woman died 10 days after inoculation due to “severe blood coagulation problems” (multiple thrombosis).
Batch ABV5300, delivered to 17 EU countries, compromises 1 million doses. Of those, suspensions as precautionary approaches have taken place in several countries, including Estonia, Lithuania, Latvia and Luxembourg.
Rumbles have also been registered in Scandinavia after Denmark recorded the death of a 60-year-old woman from a blood clot after receiving a dose from the ABV5300 batch. A two-week suspension of shots was imposed. “It is currently not possible to conclude whether there is a link,” wrote Health Minister Magnus Heunicke on Twitter. “We are acting early, it needs to be thoroughly investigated.”
Norway did not wish to be out of step “This is a cautionary decision,” chorused the director of infection prevention and control at the Norwegian Institute of Public Health (FHI). The duration of the suspension was not clarified. “We … await information to see if there is a link between the vaccination and this case with a blood clot.” And just to make the picture complete, Iceland joined the vaccine suspension family.
On March 11, the EMA tried to stem any prospect of panic. “There is currently no indication that vaccination has caused these conditions, which are not listed as side effects with this vaccine.” It added that the benefits of the vaccine “continue to outweigh its risks and the vaccine can continue to be administered while investigation of cases of thromboembolic events is ongoing.”
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) called the measure by Iceland, Denmark and Norway merely “precautionary,” “It has not been confirmed that the report of a blood clot was caused by the AstraZeneca COVID-19 Vaccine. People should still go and get their COVID-19 vaccine when asked to do so.”
Speaking for the MHRA, Dr Phil Bryan stated that, “Blood clots can occur naturally and are not uncommon. More than 11 million doses of the COVID-19 Vaccine AstraZeneca have now been administrated across the UK.” The reported blood clot cases were “not greater than the number that would have occurred naturally in the vaccinated population.”
The medical wisdom on this remains consistent: certain adverse events will happen; comorbidities can play a distracting role. To quote Dr Peter English, till recently Chair of the BMA Public Health Medicine Committee, the introduction of a new vaccine with “reports of adverse events such as this” was far from “unusual.” On the contrary, it showed “that adverse reaction monitoring systems are working” rather than indicating a causal link between the reaction and the vaccination.
A meaningful strategy against pandemic suppression is not merely whether successful vaccines can be made, let alone successfully delivered, but whether the communications work. Unfortunately for the Oxford-AstraZeneca vaccine, the patchy reputations of pharmaceutical giants, and the specific way reports on the efficacy of the product have gotten traction, have damaged it. The risks of being Handelsblatted are never far away.
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Back when Moderna and Pfizer were doing their stage 3 trials on the vaccine and had to report adverse effects in the trial participants to the US Food and Drug Administration, it was reported that the FDA took some time to conclude that a woman participant who was struck by lightning did not suffer an adverse effect from the vaccine.
And over the next 6 months or so 10,000+ Americans who have been given the vaccine will die of cancer, heart attacks or strokes: correlation is not causation!
The health authorities in various countries are simply making things worse (in terms of reassuring the public) by suspending inoculations because of a few cases of blood clots. Covid was giving some people blood clotting problems right from the beginning
Medical history has to be up to date, if you have any vaccination, your medical history is important. People do shy away from some vaccines because they require a history that person may not want to reveal or doesn’t know that their condition may be an autoimmune problem.
Knowledge is power & the more we’re informed by the adverse reactions section of Dept of health; drugs, medical procedures, implants and vaccines we would all be better off. We can’t move on until we’re all on the same page. Not different messages from all 8 states/territories. Politicians are not medical experts and they should listen. Aged Care a point in question.
Handesblatted, great. Nominating for word of the year
From earlier reports, people over 70 and those with a pre-existing condition will be receiving the Pfizer vaccine.
Update: people over 70, those with a pre-existing condition AND Scott Morrison will be receiving the Pfizer vaccine.
Ahead of the queue, hey Scotty?
Under 70 but over 60, I think I would rather pay for the Pfizer shot that Saint Scotty of the Born to Rule got free. The AZ seems to have too many issues for me to consider taking the thing.
“Ahead of the queue, hey Scotty?”
…as opposed to the “far queue” he gives to his god’s less worthy folk/
It is wrong to be lumping people with potentially serious comorbidities or family medical histories into the same public health camp as the general population (no serious comorbidities) for the purposes of applying political pressure or coercion on everyone to take one vaccine over which they are given no choice – That is not a valid public health argument. That is what Morrison is doing and yet he had a choice between two, Pfizer and AstraZeneca. We are all being told the vast majority will be given AstraZeneca, it is the only product being prepared and manufactured in this country to my knowledge. Only two have been approved for use in Australia by the TGA. I have heard nothing regarding the development, manufacture, procurement or roll out of any other product despite at least 8 candidates being used widely world wide. I have heard nothing about people with serious comorbidities being given an option even over the two we have. Just constant banter about how everyone will get their turn when it comes, be patient, supply issues and now the mass roll out of just the one vaccine to all, AstraZeneca – One size fits all. This vaccine may be fine for many, but not for all, clearly, just like any other treatment choice where there are usually a range of products to tailor to the specific health care needs and health care profiles of the individual.
I am an RN, and we should be cautious of pharmaceutical companies who push all kinds of products on the population for profit, and most of the big companies practically have most governments world wide in their pockets, they are ruthless profit engineering companies with highly effective privileged, lobbying and economic power – They need greater scrutiny and regulation not less. I have witnessed how pharmaceutical companies coerce doctors, GPs and specialists, throwing money, products and incentives at both the private and public health sectors. These Covid vaccines have been developed at lightning speed compared to vaccine development histories, and research must be rigorous, noting short cuts and compromises are far more likely in the current worldwide Covid crisis, as governments like ours play games with national interest, popularity, partisan politics and brinkmanship, for which the Liberals and the Morrison government are absolutely notorious. A second damn good reason to be cautious.
We can all be grateful that these vaccines can be produced so quickly and I am positive and supportive of public health and vaccination programs, having worked in health promotion and prevention, but I am not about to compromise my health, health care choices/treatment or vaccination and that of my family or take unnecessary medical risks because Morrison, Hunt or Frydenberg promote and coerce the population to do as they are told – On this highly complex set of issues they are in no position to advise, recommend, coerce or restrict our health care choices.
Stage 3 trials for some of these vaccines are still not completed, emergency provisions have been granted in many cases and jurisdictions (effectively shortcuts), and that is fine given the gravity of the situation. But do not expect people with family medical histories and potentially serious comorbidities to file in like sheep to vaccine clinics up and down the country and accept the AstraZeneca vaccine when there are reasonable grounds to be concerned. Yes, correlations are not necessarily causative, but neither are they unrelated just because the statistics demonstrate same levels of prevalence among the general population – That is erroneous thinking and dangerous for those who carry the risk. The statistical evidence and argument at a population level does not equate to good judgement on the individual health care level.
At risk groups in the population must be given a choice where there is one; and where there isn’t questions asked and actions taken by government to address the shortfall. No coercion, no blaming, scapegoating or bad mouthing and no disadvantaging when it comes to travel, access and life choices because an informed choice has not been given. I am not going to play Russian roulette with blood clotting in my veins just to appease Morrison’s sense of ‘indecency’ and comfort or anyone else’s for that matter. And right now, given how many countries (those which do not have a vested or invested interest in the AstraZeneca vaccine) have called a temporary halt and suspended its administration; I for one will not be accepting the AZ vaccine under any circumstances without more scholarly research, data history and clearance on drug interactions, contraindications and risk profile of this particular vaccine. No surprises here that Australia and UK are baulking the tide – That’s what conservative, authoritarian and patriarchal governments do. I rely on empirical evidence and choice, not political or commercial opinion and government inflated – compromised public health messaging and slogan.
So Morrison, get off your damn arse and public platform and provide Australians with more health care choice here other than AstraZeneca, AstraZeneca or AstraZeneca, especially when you have exercised your privilege to do otherwise. You are not the saviour of the human race, you have demonstrated your utter contempt for so many Australians most recently women, you have been grossly incompetent on every thing you do or touch including this, you are a complete and arrogant ignoramus, do not weaponise this like you have on so many other issues for your electoral ambitions.
Jon, I qualify for Pfizer but I’ll have to drive 350ks to get it.
There are only 16 sites in Australia where it is being administered.
Jon & Michael, I also qualify for Pfizer but have no chance of receiving the vaccine if it means travelling with a group or another person who may also be immune compromised. 70+ is an inconvenient truth that the government wishes would go away. 70+ people are also more likely to have blood clotting & other blood problems like bleeding too profusely when minor scratches or cuts occur. I’m just a bleeder, not a haemophiliac thank goodness, but can get traffic congestion when my blood is travelling too fast to put on the brakes. Have had a suspected aneurysm which required emergency ambulance to nearest major hospital.
Not sure I want to take the risk or offer myself up as trial case for AZ.
It’s an exercise in juggling. AZ readily admit they haven’t done enough trials in older age group, so all we need is people to offer themselves up as guinea pigs. Hey there’s a problem; you have to be healthy. LOL good luck finding them.