Wednesday 10 February 2021 6:58 pm

Why have almost half EU countries restricted use of the Astrazeneca vaccine?

The World Health Organization (WHO) this afternoon recommended the rollout of Astrazeneca’s Covid vaccine for use in all age groups, after a slew of European countries slapped limitations on the jab’s distribution.

WHO officials said a “preponderance of evidence weighed in favour of not constraining the vaccine for certain age groups”, and refused to recommend an upper age limit for the drug.

But almost half of all EU countries have now applied age restrictions to the rollout of the Astrazeneca jab, despite it receiving official approval for all over-18s by the European Medicines Agency (EMA) last month.

The limits have proved an unsettling few weeks for the Anglo-Swedish firm, which insists its Covid vaccine is safe and effective across all age groups.

Despite promising not to make a profit off its vaccine during the pandemic, Astrazeneca shares have fallen almost 22 per cent over the past six months. 

Here’s what all the wrangling is about:

What’s happening in the EU?

The Astrazeneca jab received emergency approval for use in all age groups by the UK’s drugs regulator on 30 December, with large-scale rollout across Britain beginning on 4 January. 

Just over three weeks later on 29 January the EMA followed suit, authorising Astrazeneca’s Covid vaccine for use in all adults aged over the age of 18. 

The EU’s medicines regulator said data showed a 60 per cent reduction in the number of symptomatic Covid-19 cases in people given the jab.

The ruling came as a major snub to Germany, which had already recommended blocking the Astrazeneca vaccine among over-65s following false media reports of its inefficacy in older patients.

German newspapers had claimed on 25 January that the EMA would exclude over-65s from the vaccine’s recommended authorisation because efficacy was just eight per cent in that age cohort.

German officials later U-turned on the eight per cent figure claiming it had been a miscommunication from government figures, but the headlines had already soured trust in the Astrazeneca vaccine across the continent.

Since then, 11 out of 27 EU member states have departed from official advice from the bloc’s medicines regulator and issued restrictions on the Astrazeneca vaccine.

Those countries are Italy, Spain, France, Germany, Belgium, Greece, Denmark, The Netherlands, Sweden, Poland and Austria. Norway, which is not in the EU, has blocked its use in over-65s, while Switzerland, which is also not an EU member state, has declined to approve the jab altogether.

Most have restricted use of the Astrazeneca vaccine in patients under the age of 65, but Italy, Belgium and Spain have limited it to under-55s.

Why have they restricted the vaccine?

On the surface, EU countries are concerned at the relatively low number of older patients that participated in trials of Astrazeneca’s Covid jab compared to other vaccines. 

Fewer than 10 percent of volunteers tested in Astrazeneca and Oxford University’s phase trials were aged 65 or above, whereas more than 40 percent of participants in the Pfizer/Biontech vaccine trials were aged over 55.

According to Astrazeneca data, only two out of 660 people in the trial aged over 65 became ill with Covid-19 —  a figure some EU countries have considered “insufficient” for strong statistical analysis. 

French President Emmanuel Macron claimed the data proved the Oxford jab is “quasi-ineffective” among over-65s.

But Astrazeneca has insisted that the figures do not mean that the Covid vaccine does not work well among older patients, but rather that there is currently not enough data to prove that it does.

Peter English, a Public Health England expert and former chair of the British Medical Association’s Public Health Medicine Committee, noted that the trial data should not be misread as “‘absence of evidence is evidence of absence”.

English added that it was “clearly not the case” that “because there is little direct evidence of efficacy in recipients age 65 plus, for well-rehearsed and understandable reasons, this equates to evidence that the vaccine will be ineffective in this age group”.

WHO this afternoon echoed English’s comments, adding that the confusion had arisen from the relatively small nature of the trial data.

“The results of the efficacy for persons up to 65 and older had a wide confidence interval, and therefore we feel that the response of this group cannot be any different to groups that are of a younger age,” said Alejandro Cravioto, chair of WHO’s Strategic Advisory Group of Experts on Immunization (Sage).

Cravioto said there was enough evidence to recommend vaccines to “all people 18 years and above without an upper age limit”.

What about the political rows?

Astrazeneca has insisted that nitpicking over the small-scale trial data has made the firm a scapegoat for political wrangling within the bloc.

The EU has faced mounting flak over the sluggish rollout of coronavirus vaccines among member states.

To date, around four per cent of the total EU adult population have received their first dose of a coronavirus vaccine, compared to around 20 per cent of the UK’s, which has seen more than 13m people vaccinated.

The stark difference has sparked finger-pointing from European leaders that the UK has “jumped the vaccine queue” by granting authorisation for the Astrazeneca vaccine without sufficient data.

Tensions came to a head late last month when the European Commission made demands for Astrazeneca to divert some of its vaccine supplies to the bloc. 

When Astrazeneca refused, the EU attempted to override the Brexit deal to introduce export controls on vaccines leaving the continent. 

The EU swiftly rowed back on the threats following widespread condemnation from British leaders, with European Commission head Ursula Von der Leyen admitting “complete responsibility” for the mix-up.

What next?

It remains to be seen whether EU countries that have applied limitations to the rollout of the Astrazeneca vaccine will reconsider in light of WHO’s ruling this afternoon.

Most have said they will use other mRNA-based vaccines made by companies such as Pfizer/Biontech and Moderna on older populations in the meantime, which have both received the green light from the EMA. 

Much of the backlash centres around supply of the vaccines, with both Astrazeneca and Pfizer saying they will not be able to meet their original order agreements to the EU while they scale up manufacturing facilities.

Tensions are likely to ease once other vaccines receive emergency authorisation and are rolled out across Europe.

Britain is set to receive its first batches of the Moderna jab from next month, while there are currently 63 other vaccines in the pipeline around the world, according to latest WHO figures. 

The next major hurdle will be creating a new raft of vaccines especially suited to emerging vaccine types in the coming months.

While WHO this afternoon ruled there was no evidence to suggest the Astrazeneca vaccine does not work against the South African Covid mutation, the Cambridge-based firm has already set to work developing new vaccines for mutant coronavirus strains.

Astrazeneca said it hopes to deliver the new jabs in the autumn, subject to regulatory approval, with Prime Minister Boris Johnson this afternoon telling the Commons the world will have to get used to “vaccinating and revaccinating” each year to tackle new Covid variants.

If Astrazeneca manages to take the lead in the race for the “next generation” of vaccines, it might just see European countries come crawling back to place new orders.