What is Europe’s problem with the AstraZeneca jab?

Properly applied, it is difficult to argue against it. An international academic conference in 1998 defined it as such: “When an activity raises threats of harm to human health or the environment… the proponent of an activity, rather than the public, should bear the burden of proof.”

In other words, if a company or government wants to introduce a new additive, or pesticide, or whatever, the burden is on them to prove it’s safe, rather than on the public to prove it isn’t.

And so it’s not surprising this well-established and supported principle was cited by many European countries when, one after another, they suspended the issuing of AstraZeneca’s coronavirus vaccine earlier this week. Their explanation – that there were concerns that people who’d received it had developed blood clots, and therefore there should be a pause to gather more evidence – seemed like a textbook application of the precautionary principle.

But what the moves have actually once again exposed are far less palatable aspects of European governance. Because on the basis of the precautionary principle alone, the political decisions to halt the jabs are utterly mystifying. As their own scientists and citizens have been pointing out: the number of blood clots reported in vaccinated people is no higher than that seen in the general population, while coronavirus itself comes with a high risk of blood clotting.

Making things worse – and still less coherent – is that if the European nations wanted more evidence, it is available, in public, in spades. The UK has now given more than 20 million people their first dose of either the Pfizer or AstraZeneca vaccines, and keeps a public register of reported possible side-effects of both.

As of the end of last month, people who had received the AstraZeneca vaccine had recorded around 30 blood clot issues – which might initially sound alarming, but was not outside the usual expected range for a group this large. What is especially striking, though, is that people who had received the Pfizer vaccine had recorded 38 clotting incidents. While this again was within the bounds of the expected, it is a higher figure than the AstraZeneca vaccine, and similar patterns have been seen in other European countries.

Despite this, it is only the AstraZeneca vaccine that has received this extraordinary political backlash, with Europe’s political leaders going against the evidence, the science, and their own regulators in halting a vaccine we know saves lives.

With such a baffling scenario, the question then becomes why? And there are already many conspiracy theories attempting to explain the apparently inexplicable.

Some wonder whether Russian misinformation is the answer. Is there some nefarious plot to undermine confidence in the AstraZeneca jab to pave the way for the Sputnik V vaccine currently gaining acceptance in Europe? Well there is no evidence of that, and the theory doesn’t really explain why the doubts about AstraZeneca have come from the top, from political leaders, rather than from online groups and persuadable grassroots activists.

Others note suspiciously that it is AstraZeneca, which has promised not to profit from its Covid-19 vaccine “during the pandemic”, at at the centre of this storm – rather than its profitable rivals. Yet no-one has seriously offered up a shred of evidence that it is drug industry competitors stirring up mistrust of the AstraZeneca jab – a remarkably reckless tactic that would seem likely to end up undermining confidence in all vaccines.

Inevitably, given AstraZeneca’s British links, and its widespread, rapid deployment here, there have been Brexit-related rumblings too. The theory goes that EU leaders are attacking AstraZeneca on the basis of its British connections, because they are reluctant to see it as a “Brexit success” and are inherently suspicious of it. This explanation has gained the widest traction, yet really belongs alongside the other theories, tagged as conspiracies.

And yet it does start to hint at what actually has been going on in the corridors of power in Europe. It is certainly true that European politicians have always been happier to attack companies outside the bloc than those inside.

That is not to say they are lashing out at the “British vaccine” simply because they are still in a fit of pique over Brexit. Yet there are other explanations of the leaders’ behaviour which are almost as depressing. One is to remember that politics is often stupid and petty, and that the response to coronavirus is unavoidably political.

Several European political leaders have already been in public spats with AstraZeneca. These began in January when European leaders were far keener on the AstraZeneca jab and refused to accept that the UK had first claim on its doses produced in European plants.

It was a bruising battle and without revisiting all the rights and wrongs of that case, it is fair to say that the row deflected political and media flak that the bloc was taking at the time for its painfully slow vaccine rollout.

Once you have a political villain in your sights, acting against it is much more tempting – and if it can be argued the AstraZeneca vaccine was even questionably unsafe, then delays in rolling it out can be framed as sensible caution rather than political ineptitude.

This kind of ass-covering can happen in less cynical ways, too: once one government has decided to pause the vaccine rollout – whether for good reasons or bad – other governments have an incentive to do the same. Making a bad decision as part of a pack is politically much safer than risking being the lone standout on a good decision. When in doubt, herd.

All this is exacerbated by the high rates of vaccine hesitancy and outright anti-vaccine sentiment in many European countries. Once several countries had suspended AstraZeneca, Macron may have felt in France, with almost 50% vaccine hesitancy, he had no choice but to follow suit.

Critics, though, might note that by doing so Macron has validated those rules and will make his eventual task of vaccinating the public even harder still. Pander today, pay tomorrow.

A final bit of context for this is Europe’s – and especially the EU’s – supposed hyper-caution on technology and science. The bloc has a long history of framing inaction as sensible prudence, of confusing ass-covering with the precautionary principle.

To take just one example – and to leave the thorny issue of genetically-modified foods out of it – the hypothetical dangers of nuclear power, especially since the Fukushima disaster ten years ago this month, were used to keep coal power plants online in Germany – indirectly contributing to thousands of air pollution deaths.

Europe has a long record of prioritising hypothetical dangers over real ones. Given that history, letting people die of coronavirus to ‘save’ them from vaccines their own regulators say are safe, is grimly unsurprising.

And die they will: these delays will have a measurable cost in lives. European countries are battling yet another wave of coronavirus re-emerging, and many countries are having to introduce stricter lockdown measures yet again – an inevitable result of reopening with an unvaccinated population.

Cases across the bloc are up 50% versus three weeks ago, with France and Italy both now recording 25,000 new cases daily and still higher case and death rates in eastern Europe.

If that news weren’t bad enough on its own, this is perhaps the worst time in the whole pandemic for coronavirus to be uncontrolled: the period where a fraction of the population is vaccinated is a high-risk one for mutations – if we want the vaccine to stay effective, we need to minimise Covid’s chance to mutate.

For much of the crisis, European leaders have been able to look to the UK as a basket case of what not to do – and despite a successful vaccine rollout to date, UK politicians, civil servants and scientific experts will in time face a deserved reckoning for their part in the UK’s 125,000 coronavirus deaths.

Unless Europe’s political leaders get their act together on vaccination – and fast – they will deserve a reckoning of their own, too.

How it happened…

At the core of the controversy is a question over whether the AstraZeneca vaccine is causing blood clots, an issue initially raised by the national medicine regulators of Germany and Denmark.

Blood clots are not an unusual condition (especially in older patients) but can be life threatening, and statements from Germany’s regulator suggested they had seen more indications of a specific type of clotting than they might otherwise expect from people who had recently had the vaccine – though it was not clear whether any of these had led to serious complications or death.

All major healthcare systems have systems to log side-effects and look for patterns, and these generally record thousands of incidents (overwhelmingly minor) for mass vaccinations.

The German regulator recorded seven possible incidents of this particular clotting among 1.6 million patients – a relatively rare potential side-effect, even if it was confirmed as such, rather than a mere coincidence. There has also been, to date, no proposed causal mechanism as to why the vaccine would cause this particular effect.

What should have happened next and what actually happened next are very different things. European nations, when they had agreed an EU-coordinated vaccine rollout, agreed a process by which the Europeans Medicines Agency (EMA) would take the lead on investigating possible adverse effects to the vaccines.

Having been notified of the concerns, the EMA did just that, launching an expedited investigation – but making it clear in no uncertain terms that its view was the vaccine rollout should continue during the week or so its investigation took, and that the evidence was not sufficient to pause that rollout.

But one by one the governments of most of the leading countries of the EU acted against the EMA’s advice and paused the rollout of the AstraZeneca vaccine. In many instances, countries didn’t even pretend to be following the advice of their national regulators – Emmanuel Macron announced the suspension of AstraZeneca personally, rather than leaving it to experts or officials.

TIMELINE

May 2020

The UK agrees a binding deal with AstraZeneca establishing a dedicated UK supply chain for its vaccine

June 2020

The Inclusive Vaccine Alliance (IVA) group, led by Germany, France, Italy and the Netherlands, agree a deal with AstraZeneca to supply Europe with 400 million doses of vaccine, provoking accusations of queue-jumping and side-deals from other EU nations

August 2020

The EU Commission signs a deal with AstraZeneca, superseding the ICA agreement; the UK and AstraZeneca sign their deal, incorporating the supply chain terms agreed in May

December 2020

The UK approves the AstraZeneca vaccine, with the first doses administered days later

January 2021

The European Commission approves the jab for all ages. Germany and several other EU nations restrict its use to under-65s, citing “insufficient data” over its efficacy for older people. Emmanuel Macron, with no evidence to support his claim, describes the jab as “almost ineffective” on over-65s. Even before approval is granted, the Commission accuses AstraZeneca of breaking its vaccine delivery commitments to the EU

February 2021

Macron says he would happily receive the AstraZeneca vaccine if that was what he was offered, while Angela Merkel says she will not have the jab because it is not recommended for her age group. Figures show four out of five AstraZeneca vaccine doses delivered to EU countries are yet to be used

March 2021

Germany approves the vaccine for use in over-65s before the country – along with Spain, Italy, France and many other EU nations – later suspend its use, against the advice of their regulator EMA. Of 17 million doses administered in the UK and EU, more than 11 million have been in the UK.

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