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European countries suspend use of AstraZeneca vaccine over blood clot death fears

A number of European countries have paused their use of the AstraZeneca-Oxford University coronavirus vaccine after someone who received it in Denmark died from a blood clot.

Denmark, Iceland and Norway have suspended vaccinations using the AstraZeneca jab entirely while the incident is investigated.

A number of other countries, including Italy, have temporarily stopped using two different batches of the AstraZeneca vaccine, after reports in Italy of a “serious adverse event” linked to one batch, and a death and illness in Austria related to another batch.

However, the European Medicines Agency said there was no evidence of a link between the events and the jabs, stressing that “the vaccine’s benefits currently still outweigh the risks". It urged countries to continue with their vaccination campaigns.

It comes as Brussels warned Europe's supplies of AstraZeneca jabs could fall short in the first quarter of the year.

Thierry Breton, the internal market commissioner, told the Financial Times: "I see efforts - but not best efforts. That's not good enough yet for AstraZeneca to meet its Q1 obligations."

The AstraZeneca jab has had a bumpy ride in Europe following French President Emmanuel Macron’s criticism of its use for older adults. However, countries are scrambling to speed up their roll-outs amid fears the continent could be facing a third wave of infections.

Other countries, including the UK, Sweden, Spain and France, said they had no evidence of any links between the vaccination and blood clots, and would continue with their vaccination campaigns. 

Denmark's health minister Magnus Heunicke said in a statement on Twitter that the country was acting "on the precautionary principle" after the death of the person post-vaccine. It will pause use of the jab for at least two weeks. 

"We cannot yet conclude that there is any connection," he said. "We are taking action early and this will now be thoroughly investigated."

Italy has also suspended its use of a batch of the AstraZeneca vaccine, labelled ABV2856.

There have been media reports of at least one death in a person after they received the jab.

Its medicines regulator AIFA said: "Following the reporting of some serious adverse events... AIFA has decided, as a precaution, to issue a ban on the use of this batch throughout the national territory.” 

However, it stressed there was as yet no established link between the administration of the vaccine and the alleged side-effects.

A number of other countries have paused their use of a different batch of the AstraZeneca vaccines, ABV5300, which has been delivered to 17 EU countries. It has been linked to a death from coagulation disorders and an illness from a pulmonary embolism in Austria.

Austria, Latvia, Estonia, Lithuania and Luxembourg have said they will temporarily suspend using this batch while the events are investigated.

It is not yet clear which batch Denmark was using.  

The European Medicines Agency is investigating the reports, but stressed that the number of "thromboembolic events" - marked by the formation of blood clots - was no higher among vaccinated people than in the general population. It said 30 cases had been reported among the close to 5 million vaccinated with the AstraZeneca vaccine in the European Economic Area.

Dr Phil Bryan, vaccines safety lead at the British regulator, the Medicines and Healthcare products Regulatory Authority (MHRA), said 11 million doses of the AstraZeneca vaccine had been given in the UK, also with no more reports of blood clots than in the unvaccinated population.

Prime Minister Boris Johnson's spokesman told reporters: "We’ve been clear that [the AstraZeneca vaccine] is both safe and effective...When people are asked to come forward and take it, they should do so in confidence."

Spain, France, the Netherlands and Sweden, all of which are using the ABV5300 batch of vaccines, also said they would continue with their roll-outs.

Spain's health minister Caroline Darias said they too had not registered any cases of blood clots related to the AstraZeneca vaccine.

France also said it saw "no need" to suspend use of the AstraZeneca vaccine.

The Dutch Medicines Evaluation Board said that there was no evidence of a link, adding: "Thrombosis and pulmonary embolism are not known side effects of the vaccine. When large groups are vaccinated as is now the case, then you can expect such reports."   

An AstraZeneca spokesperson said patient safety was its “highest priority”, adding: "The safety of the vaccine has been extensively studied in Phase III clinical trials and peer-reviewed data confirms the vaccine has been generally well tolerated.”

Professor Stephen Evans from the London School of Hygiene & Tropical Medicine said pausing the use of the AstraZeneca doses was "super-cautious" and needed to be considered in light of the risks of clots associated with Covid-19 itself.  

He said: “This is a super-cautious approach based on some isolated reports in Europe.  The problem with spontaneous reports of suspected adverse reactions to a vaccine are the enormous difficulty of distinguishing a causal effect from a coincidence.

“This is especially true when we know that Covid-19 disease is very strongly associated with blood clotting and there have been hundreds if not many thousands of deaths caused by blood clotting as a result of Covid-19 disease."

He said it was a "sensible approach" to investigate, but added: "The risk and benefit balance is still very much in favour of the vaccine in my view."