Prioritising risk rather than reward left Europe playing catch-up on jabs

‘Before pursuing an age-based approach acceptable vaccine safety and efficacy needs to be shown among older adults’

‘The reported rate varies very much with how good the reporting system in a member state is and how well cases are being identified’

We humans like nothing better than storytelling – and the more familiar the book the better. It’s why the tragedy of Romeo and Juliet has been told a thousand times. Explaining things in common narrative is one of our many quick tricks for making sense of the world.

The oldest story of them all is the clash of nations and it’s through this prism the story of the AstraZeneca jab in Europe has been told. How else to explain that Europe started off by limiting the vaccine’s use in the old only to reverse ferret, prioritise the old and then restrict its use in the young?

The truth is of course more complicated. The bumpy ride the AstraZeneca vaccine has had in Europe and North America has much more to do with the different ways in which regulators approach evidence and judge risk than politics.

The initial decision of some countries, France and Germany included, to restrict the use of the vaccine to younger age groups stems from the fact that the vaccine was not well tested among older cohorts in the original trials.

Add to this the fact that the tolerance and effectiveness of many vaccines falls away in older age groups and the argument for prudence becomes clear – even though it was never clear cut.

As The Sunday Telegraph reported at the time, The European Centre For Disease Control (ECDC) was making this point long before any vaccines had been licensed.

In a paper published on Oct 26 it said: “Before pursuing this [age-based] approach, acceptable levels of vaccine safety and efficacy need to be demonstrated among older adults. At this stage, this information is not known”. Instead, the ECDC recommended an “adaptive approach” – one which would flex as more was learnt about the jabs and their impact.

With a glut of AstraZeneca vaccine coming our way and a second wave of the virus brewing, the UK authorities emphasised the other side of the risk-reward equation.

Yes, there was a lack of evidence for the vaccine in older groups but there was crystal clear data to show that Covid-19 kills older people at a much higher rate. The risk of death for a healthy 70-year-old is one in 1848 compared with one in 250,000 for a 30-year-old – 135 times greater.

With hindsight, the UK authorities made the right call. The AstraZeneca jab and others have turned out to be extremely effective in older groups and the decision to prioritise them is estimated to have saved about 10,000 lives to date.

Following its “adaptive” strategy, Europe has rightly followed suit.

But what of the decision in parts of Europe and Canada to now restrict the vaccine to older groups – those above 55 or 60. How to make sense of that? The same culture of caution – again dictated by differing circumstances – may help explain it.

Europe was hit disproportionately hard by scandal following the 2009 swine flu pandemic when the Pandemrix vaccine, widely distributed to health care workers, was linked with rare cases of narcolepsy. Some 1,300 people have been affected among the roughly 30 million vaccinated across Europe, but with only around 100 in the UK.

Scientists in Germany and Scandinavia, in particular, became black-belts in pharmacovigilance in the wake of the scandal; few if any are as good at analysing the thousands of adverse reaction reports that flow in when a new drug is launched. They are expert at sifting the wheat – genuine early signals of a problem – from the mountains of chaff.

It was Norwegian and German regulators who first spotted the rare blood clotting issue now linked to the AstraZeneca jab. The UK authorities have since identified 79 cases here, putting the incidence risk at about one in 250,000.

The reported rate “varies very much with how good the reporting system in a member state is and how well cases are being identified”, said a spokesman of the European Medical Agency last week. “In Germany, a lot of work has been done and I think there is a reporting rate of one in 100,000.”

In the UK, we have now offered a choice of vaccines to those under 30. In other countries the cut-off is higher – 55 in Canada for instance. These decisions are not driven by the incidence of clots necessarily being higher in the young – there is as yet no hard data to show this. Instead, it is because the risk from Covid is so much lower in the young.

Why the difference in ages? Again that has more to do with circumstance than politics. In Europe, they have more of the Pfizer and Moderna vaccine.

In the UK we remain more reliant on AstraZeneca – for the moment at least.