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A wave of EU countries moved Monday to suspend use of the Oxford/AstraZeneca coronavirus vaccine, ignoring the advice of the bloc’s medicines regulator as investigations continue into cases of blood clots.
Within hours Monday afternoon, France suspended use of the vaccine until at least Tuesday afternoon and Germany did the same indefinitely after newly reported cases of blood clots. Italy made a U-turn decision after its drugs regulator said Sunday the vaccine is safe, and Spain’s health minister announced a pause while waiting for an assessment by the European Medicines Agency, possibly for up to two weeks. Cyprus also followed suit.
Amid concerns over the safety of the vaccine, countries face a dilemma over whether the proven benefits of the Oxford/AstraZeneca jab outweigh any as-yet-unproven link to blood clots — and the growing consensus is to wait for firmer scientific evidence.
In a statement Monday, the EU’s regulator held to its position from last week and said that it “currently remains of the view that the benefits of the AstraZeneca vaccine in preventing COVID-19, with its associated risk of hospitalization and death, outweigh the risks of side effects.”
The EMA’s safety committee, however, “will further review the information [Tuesday] and has called an extraordinary meeting on Thursday, 18 March, to conclude on the information gathered and any further actions that may need to be taken,” the regulator said.
Commenting on the suspensions, the EU’s Economy Commissioner Paolo Gentiloni said Monday, “Of course, we need speed, not only for the economy, but also for the health of our citizens. But at the same time, we need certainty.”
Gentiloni told a press conference following a meeting of finance ministers that the “precautionary measures are justified” until further assessment from the EMA can “give certainty to our EU citizens.”
AstraZeneca has already pushed back, saying Sunday in a statement that the numbers of adverse incidents have been lower than those expected in a general population.
“So far across the EU and U.K., there have been 15 events of [deep vein thrombosis] and 22 events of pulmonary embolism reported among those given the vaccine,” the company said. That’s “lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines.”
However, French President Emanuel Macron said his decision to pause the vaccine until Tuesday afternoon was pegged to the expectation that the EMA will publish new guidance then — a statement that came out before the EMA issued its notice about the meeting Thursday.
The decision to suspend is “a precautionary measure,” Macron said at a press conference with Spanish Prime Minister Pedro Sánchez.
In their announcements, others countries also emphasized that their decision was made as a precaution.
“In the light of these newly reported cases, the [medical regulator] Paul Ehrlich Institute today reassessed the situation and recommended a suspension of the vaccination and further investigations,” said German Health Minister Jens Spahn at a press conference in Berlin.
In the case of Italy’s drug regulator, AIFA, it halted the vaccine throughout the country after two batches had already been suspended. The first was halted on Thursday, after it had been possibly linked to two deaths in Sicily. Italian media reported the suspension had come at the behest of local authorities, and not from the drug regulator.
The second batch that was withdrawn was in the northern region of Piedmont. The decision, taken on Sunday, was also made by regional officials, after the death of a schoolteacher.
For its part, as recently as Sunday evening, AIFA said that “the concern over the safety of the AstraZeneca vaccine is not justified.”
“The deaths verified after the administration of the AstraZeneca vaccine have only a chronological connection,” it wrote. “No causality has been demonstrated between the two events.”
But on Monday evening, AIFA was forced into a U-turn, suspending the vaccine throughout the country. It said the decision was “in line with” with other European countries, but emphasized it was done as a “precaution and temporarily,” as it waits for EMA guidance.
All of these moves also go against guidance from the World Health Organization, which said on Friday countries should continue to use the Oxford/AstraZeneca vaccine — and that it will hold this position until it has clarified a causal relationship between the vaccine and reports of blood clotting incidents.
The domino effect began Thursday when Denmark was the first to pause the entire rollout of Oxford/AstraZeneca vaccines. Norway and Iceland followed suit.
Austria, Denmark, Estonia, Lithuania, Luxembourg, Latvia, Italy, Bulgaria and Romania then suspended the jab as a precautionary measure, and the Netherlands and Ireland did the same on the weekend.
The EMA said Friday its drugs safety committee is reviewing blood disorders that have been reported in the aftermath of vaccination with the Oxford/AstraZeneca jab. But it also noted that it’s looking at the two other approved coronavirus vaccines, BioNTech/Pfizer and Moderna, in relation to potential health problems.
The EMA review includes blood clots after vaccination with the Oxford/AstraZeneca vaccine as well as low platelets — the cells that aid clotting — after vaccination with Oxford/AstraZeneca, BioNTech/Pfizer or Moderna.
In Denmark, meanwhile, all those who have been vaccinated are being sent letters to increase awareness of the symptoms associated with low platelets, such as bruising and bleeding.
“If you have been vaccinated with the AstraZeneca vaccine within the last 14 days and you experience signs of skin or mucosal bleeding, you should see a doctor,” the Danish Medicines Agency said Monday. “This could for example be easy bruising — except for at the injection site, which is normal — or small red spots on the skin or bleeding that does not stop as normal.”
For its part, the EMA said Monday that these temporary suspensions are “a precaution taken in the light of their national situation while EMA investigates a number of events of blood clots in people who had received the vaccine.”
Many thousands of people develop blood clots annually in the EU for different reasons, the EMA noted. The number of such events overall in vaccinated people doesn’t seem to be higher than that seen in the general population.
However, it said, its investigations are ongoing, and the agency will “continue to communicate further as appropriate.”
Speaking alongside Gentiloni on Monday evening, Paschal Donohoe, Ireland’s finance minister, said the suspensions were “the right decision.”
“I believe any short term effects on economic activity that could be caused by what I hope is a temporary suspension of the use of one vaccine, I believe will be offset by the great prize of retaining confidence in how safe our vaccines are and in an effective vaccination program in the weeks and months to come,” he said.
Bjarke Smith-Meyer, Nette Nöstlinger, Nektaria Stamouli and Cristina Gallardo contributed reporting.
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.
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