Big read: An A to Z of the AstraZeneca row and its side effects

Soon reports emerged from Norway that four people who had received a dose of the AstraZeneca vaccine had experienced severe blood clots and one of them died. All were under 50 and it was reported that three were healthcare workers.

Health authorities in Denmark were the first to suspend all use of the vaccine. It was reported that a woman there had died after developing a blood clot. Norway followed Denmark’s lead and on Sunday morning it was announced that the AstraZeneca vaccine would be paused in this country too.

The news was seen by some as a hammer blow in the already sluggish vaccine roll-out. Some 30,000 people — healthcare workers and people aged 16 to 69 with several underlying health conditions — who had been scheduled for vaccination this week were told their appointments were being delayed.

The decision was taken by the National Immunisation Advisory Committee (NIAC) after the Health Products Regulatory Authority (HPRA) received a safety alert from the Norwegian Medicines Agency. NIAC chairwoman Karina Buckley recommended that administration of the vaccine be deferred pending the outcome of an EU-level investigation.

The decision appeared to have divided the country’s medical and scientific community. On Monday, Professor Luke O’Neill of Trinity College Dublin’s School of Biochemistry and Immunology — one of the most recognisable experts on the pandemic — said he found the suspension “dangerous”.

“They are not trusting the science,” he told Pat Kenny on Newstalk. “17 million people have had this vaccine and there is no evidence of any kind that it is causing blood clots. And, even worse, we know the virus itself causes blood clots — there is a high risk of that — so they are putting 30,000 people at risk now who aren’t getting vaccinated this week, so I think it is very disturbing, to be honest.”

In something of a domino effect, several countries including Germany, France, Italy, Spain, the Netherlands and Thailand suspended the vaccine.

As the week wore on, it seemed as though almost every country in the EU — despite low vaccine supplies overall — had decided to suspend use of the AstraZeneca shots, but would continue to use the Pfizer/BioNTech and Moderna vaccines. By contrast, Belgium insisted it would continue to use AstraZeneca as planned, arguing that the benefits in combating Covid hospitalisations and deaths greatly outweighed any negatives.

The European Medicines Agency (EMA) gave the vaccine the all-clear on Thursday following a detailed review. Irishwoman Emer Cooke, its executive director, said there was a “clear scientific conclusion — this is a safe and effective vaccine”.

But with many of the vulnerable who had been due to get the vaccine this week now unlikely to get their first dose until well into next month, there are concerns that the pause in vaccinations could lead to some getting seriously ill and dying.

With case numbers stubbornly high and even a slight easing of restrictions on April 5 in the balance, the decision will have dismayed not only those due to get the shot this week. It has complicated an already frustratingly slow rollout, a result of the EU’s failure to acquire sufficient supplies of the vaccine in the first quarter.

By contrast, AstraZeneca has been at the forefront of the fast and impressive vaccine rollout in the UK, where more than 40pc of adults have received at least one shot. Case numbers have dramatically fallen and restrictions are set to be reduced shortly, with church services likely to take place again in Northern Ireland by the end of this month. In Wales, personal services such as hairdressing, have resumed — a direct result of the effectiveness of the vaccine programme.

Michael Head, an infectious disease specialist and a senior research fellow in global health at the University of Southampton, says the decision to suspend vaccinations did not make sense.

“It’s right that countries investigate signals, for example possible adverse events such as Germany has described — seven cases of rare but serious blood clots,” he says. “But why you would pause a vaccine campaign to investigate that — that’s what I’m really confused about. The signals are very small; Covid is very big. You’re pausing a vaccine roll-out during a pandemic to investigate a tiny number of possible signals.

“And it appears that some countries suspended their vaccination campaigns because other countries have. And all of this in an environment where, in places like France and Germany, cases are going up. These are countries with a big Covid-19 problem on their doorstep so people are being under-protected when they could be protected.”

About 11 million AstraZeneca Covid jabs have been administered in the UK in the past three months with no alarming signals, but Head fears that confidence in this vaccine and others will be damaged because of the confusion surrounding its safety. “There are lots of consequences to stopping a vaccination campaign, particularly in a time of public health emergency like this,” he says.

AstraZeneca vaccinations took place as normal in the UK this week, but health authorities found themselves compelled to reassure the population about the medicine’s safety. By the middle of the week, British newspapers were reporting that some people in England were cancelling vaccine appointments over fears that they would receive the AstraZeneca shot.

David Robert Grimes, a science writer with expertise in medical and science disinformation, says there are legitimate concerns that the AstraZeneca controversy will play into the hands of ‘anti-vaxxers’.

“There’s no doubt in my mind that those that put out vaccine disinformation will feel emboldened by what’s happened this week,” he says. “Even a quick response from the EMA is unlikely to quell the sort of conspiracy theories that have grown around Covid-19 in general and the vaccines specifically.”

Grimes says he was surprised by the suspension of the vaccine considering the UK’s experience. “There has been a huge programme of AstraZeneca vaccinations there and they have not detected a rise in thrombotic events,” he says. “Between the UK and the EU, around 17 million doses of the vaccine have been administered and nothing that has happened is indicative of elevated risk.”

Liz O’Brien, a former pharmaceutical regulator and ex-staffer at the EMA, believes NIAC was correct to pause its use. “My default position always goes back to patient safety,” she says, “and I fully understand the dynamics and complexity of stopping it from a logistics and perception perspective, but ultimately when you’re seeing really rare cerebral venous sinus embolism in your brain in young people, that is highly unusual. And you would have to adjudicate if that is related to the intervention [the vaccine] or not. The chances are is it’s not. But having said that, it would be unforgivable to move forward if there was any potential casualty. In the grand scheme of things, pausing it — while it’s disruptive — is the best thing to do.

“If I was to personalise it, if it was myself or my parents considering taking the vaccine, I’d say, ‘Wait. Let’s just wait until this review is completed and we move on then’.”

Amy Morgan, a GP in Drogheda, Co Louth, also believes health authorities did the right thing, but hopes the move has not damaged confidence in the jab.

“The message I’d have for patients would received it is that for now, the EMA and World Health Organisation have said AstraZeneca is safe,” she says. “But it’s really important for confidence in the vaccination programme that these clusters of events are investigated, just like we would for any other medicine. There may be no direct link at all but it makes sense to pause and investigate and allow the experts time to examine the evidence.

“We often counsel our patients to let us know if they experience side effects from any medicine and this is no different. Ultimately a deferral should not dramatically delay vaccination for those people — those mostly who were in vulnerable groups — who were due to receive it. If patients did have any concerns we of course, as their GPs, would explore these but for now would be seeking to largely reassure people.”

It is not the first time that the British-Swedish company AstraZeneca has found itself the centre of controversy over the vaccine.

For much of February and March, there was considerable confusion throughout Europe about AstraZeneca’s effectiveness in people over 70, partly because the company had carried out fewer trials in this age group. The vaccine’s public image was not helped when French president Emmanuel Macron claimed in January that it appeared to be “quasi-ineffective”. Last week, NIAC issued fresh advice to the Department of Health in which it said the vaccine was safe to use in that age group. Previously, it had said that while Astra Zeneca could be used on senior citizens, it was preferable to use either the Pfizer or Moderna shots.

AstraZeneca has been regularly criticised by European Commission President Ursula von der Leyen for its failure to meet supply targets. She has said the company has been “underproducing and underdelivering” and has blamed it for delays to the EU’s vaccine programme.

The company has said it will not be able to meet its contractual commitment of 300m doses for the EU in the first half of the year but instead will be able to supply only 100m due to production problems and export restrictions.

With parts of Europe on the crest of a third wave of virus transmissions — not least Italy, which went into full lockdown on Monday amid rising numbers of hospitalisations and deaths — Von der Leyen is threatening to block vaccine deliveries to the UK and elsewhere under emergency powers.

It was all so different on November 23 last when AstraZeneca, in partnership with Oxford University, announced that it had created an effective vaccine.

This came just weeks after first Pfizer-BioNTech and Moderna had publicised their vaccine breakthroughs. The AstraZeneca shot was hailed as a game-changer because it would not require the deep-freeze refrigeration required by the other two. Instead, it could be stored in conventional fridges and could easily be distributed to vaccine centres, GP surgeries and pharmacies.

Despite this advantage, initial studies on its effectiveness made it look less promising than its rivals. It reported 70pc efficacy, compared with the 90pc-plus results posted by Pfizer and Moderna, although a report published in the Lancet medical journal this month demonstrated efficacy of 76pc on one standard dose. British studies have also indicated that it significantly reduces Covid transmission after one dose.

The speed with which vaccines were developed was hailed as a scientific miracle last year. Some pandemic experts had thought an effective vaccine might never be created.

The coronavirus vaccine partnership between AztraZeneca and Oxford’s Jenner Institute came into effect as recently as April 30 last year. Scientists including Ireland’s Professor Teresa Lambe worked round the clock to develop the medicine.

More than a month after it was approved for use in the UK, the EMA granted it a licence on January 23.

AstraZeneca has accounted for more than one quarter of the 758,490 vaccines delivered here so far and about a fifth of the total number of doses (620,580 up to Monday) that have been administered.

On Thursday, in advance of the EMA’s green-light, the HSE said it did not anticipate any logistical obstacles and would reintroduce the AstraZeneca jabs immediately.

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