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Friday, May 14, 2021

EU countries halt Oxford/AstraZeneca vaccine rollout over blood clots

Countries across Europe are suspending — some fully, some partially — the rollout of the Oxford/AstraZeneca jab after reports of blood clotting after vaccination.

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There have been several deaths from clotting, but health authorities have stressed there’s no indication of a link to vaccination. Still, Austria, Denmark, Estonia, Lithuania, Luxembourg, Latvia and Italy, as well as non-EU Norway and Iceland, have all suspended the rollout of at least some Oxford/AstraZeneca batches as a precautionary measure. 

On Thursday, Denmark launched more extreme measures when it paused the entire rollout of Oxford/AstraZeneca vaccines. Norway and Iceland followed suit and halted all distribution of the jab. 

It’s the latest blow for a European vaccination program that can’t seem to catch a break, whether it’s the threat of new variants, the sluggish start or production snags.  

The dominoes started falling on March 7, when Austria announced it was suspending the rollout of a specific batch after one person died and another fell ill with blood clotting conditions after vaccination. 

The batch — ABV5300 — was delivered to 17 European countries (Austria, Bulgaria, Cyprus, Denmark, Estonia, France, Greece, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Spain and Sweden) and in total comprises one million doses.

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While Italy hasn’t received that specific batch, it announced on Thursday that it’s pausing the rollout of a different batch — ABV2856. 

The Italian news agency ANSA reported that the halt was prompted by two deaths, both in Sicily, that are possibly connected to the batch. The latest, 43-year-old serviceman Stefano Paternò, was found dead in his home on Wednesday morning after having suffered a heart attack. He had been given the vaccine the day before. 

Police officer Davide Villa, 50, died 12 days ago, also after a dose from batch ABV2856, prompting the prosecutor’s office to open a manslaughter investigation. 

The European Medicines Agency said that as of March 10, there were 30 reported cases of blood clotting-related incidents out of close to five million people who have received the Oxford/AstraZeneca vaccine in Europe, excluding the U.K. The regulator said the figures are “no higher than that seen in the general population,” and there’s no indication that the vaccine caused the conditions.

However, its safety committee is reviewing whether there are any potential issues with the specific batch as well as looking at the blood-clotting related events more broadly. 

“Although a quality defect is considered unlikely at this stage, the batch quality is being investigated,” the EMA said on Wednesday.

Blood clotting-related conditions such as multiple thrombosis and pulmonary embolism aren’t listed as possible side effects of the Oxford/AstraZeneca jab. 

In a statement, AstraZeneca said that patient safety is the “highest priority” for the company.

“Regulators have clear and stringent efficacy and safety standards for the approval of any new medicine, and that includes COVID-19 vaccine AstraZeneca,” said the company. “The safety of the vaccine has been extensively studied in Phase 3 clinical trials and peer-reviewed data confirms the vaccine has been generally well tolerated.” 

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Not all European countries are following suit, and experts have urged the public not to panic about the new developments. 

Describing the suspension of vaccination as a “super-cautious approach,” Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said that with spontaneous reports of adverse reactions, there’s “the enormous difficulty of distinguishing a causal effect from a coincidence.”

This approach may be justified if there’s no shortage of alternative vaccines, but if the move stops vulnerable people from getting vaccines, “then it is a mistaken use of precaution,” he added.

In the U.K., more than 11 million doses of the Oxford/AstraZeneca vaccine have been administered — more than double the number across Europe. The weekly adverse reaction report, updated Thursday, shows there have been three deaths and 45 non-fatal blood clot-related events in the aftermath of getting the Oxford/AstraZeneca vaccine, and one death and 48 non-fatal blood-clot related events after the BioNTech/Pfizer jab.

“Reports of blood clots received so far are not greater than the number that would have occurred naturally in the vaccinated population,” said Philip Bryan, vaccines safety lead at the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA).

“The safety of the public will always come first,” he said in response to reports of Denmark’s suspension. “We are keeping this issue under close review but available evidence does not confirm that the vaccine is the cause.”

This article is part of POLITICO’s premium policy service: Pro Health Care. From drug pricing, EMA, vaccines, pharma and more, our specialized journalists keep you on top of the topics driving the health care policy agenda. Email [email protected] for a complimentary trial. 

(Except for the headline, this story has not been edited by WCT staff and is published from a syndicated feed.)

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