European countries to resume AstraZeneca jabs after safety backing

EMA says benefits outweigh risks but it is continuing to study possible link with very rare blood clotting disorder

Italy, France, Germany and several other countries will resume administering AstraZeneca jabs from Friday after Europe’s medicines regulator said the vaccine was “safe and effective” and its benefits outweighed its risks.

Portugal will resume on Monday, Spain and the Netherlands next week, while Sweden’s public health agency said it would take “a few days” to decide.

The European Medicines Agency (EMA) had launched a review after about 30 cases of unusual blood clotting and low platelet counts in recipients of the vaccine prompted more than a dozen EU countries to suspend its use.

The EMA’s director, Emer Cooke, said the agency’s safety committee had reached “a clear scientific conclusion” and had not found that the vaccine was associated with an increase in the overall risk of blood clots.

However, it did uncover “a small number of cases of rare and unusual but very serious clotting disorders”, and Cooke said the EMA could “not rule out definitively a link between these cases and the vaccine”, which was being investigated.

A warning in the vaccine information would draw attention to “possible rare conditions” to help recipients and healthcare professionals “prevent and mitigate any possible side-effects”, she said.

Several EU countries embarking on a third wave of coronavirus driven by more infectious new variants and struggling to accelerate sluggish inoculation programmes welcomed the decision. Italy’s prime minister, Mario Draghi, said AstraZeneca vaccinations would resume on Friday. Germany’s health minister, Jens Spahn, made a similar announcement, as did Cyprus, Latvia, Lithuania and Slovenia.

The French prime minister, Jean Castex, said he would get vaccinated on Friday to set an example.

Cooke said: “We have vaccines that can prevent death and hospitalisation. We need to use them. A lot of member states are waiting for the outcome of this safety review. Countries can now make an informed decision so as to the safety of the vaccine.”

Austria, the Baltic states, Denmark, France, Germany, Ireland, Italy, the Netherlands, Portugal, Spain and Sweden, along with non EU-member Norway, were among the European countries to either pause use of the vaccine or ban specific batches.

Cooke said investigations were continuing into the rare events, but she added: “About 7 million people have now been vaccinated in the EU with the AstraZeneca vaccine, and 11 million in the UK … I want to reiterate that our scientific position is that this vaccine is a safe and effective option to protect citizens against Covid-19.”

She said the agency’s investigation to date had not uncovered any problems related to specific batches of the shot or manufacturing sites. “If it was me, I would be vaccinated tomorrow,” she said. “But I would want to know what to do if I had any problems – and that’s what we’re doing now.”

Britain’s medicines regulator the MHRA also said the evidence did not suggest that the AstraZeneca vaccine caused blood clots, but it too was still investigating a very rare and specific type of blood clot in cerebral veins.

The MHRA said there had been five cases of cerebral venous sinus thrombosis (CVST) combined with a low platelets count in recipients of the vaccine in the UK, and there was no need to pause inoculations.

A British expert, Prof Sir Munir Pirmohamed, who chairs the Commission on Human Medicines, said that even if a link between CVST and the shot was found, it was unlikely the UK vaccination campaign would be halted since the incidence rate was so low.

Norway’s expert group said on Thursday that after investigating the cases of three health workers who had fallen ill with the same combination of CVST and low platelet counts, one of whom died, they believed a strong immune reaction to the vaccine was the cause.

“We have no other history in these patients that could give such a strong immune response,” Prof Pål Andre Holme said. “I am absolutely certain it is these antibodies that are the cause and see no other reason than … the vaccine that triggers it.”

The World Health Organization’s global vaccine safety panel is examining the vaccine data and the precise clinical circumstances of each rare blood coagulation case and will publish its findings on Friday.

AstraZeneca has said the number of cases of blood clots reported “is lower than the hundreds of cases that would be expected among the general population”.

Denmark, the first country to suspend the shot last week after a 60-year-old woman died from a “highly unusual” blood event, and Germany, where three recipients have died from the rare cerebral vein thrombosis, have said they acted on strictly scientific grounds.

Because of the extreme rarity of the events, the decision to pause the shot has been criticised as political, with Belgium saying it was “irresponsible”.

The AstraZeneca vaccine was already perceived by many in the EU as second best after several national agencies postponed its authorisation for the over-65s because of a lack of data. Experts fear the suspensions may further depress its take-up.


Jon Henley and Nicola Davis

The GuardianTramp

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