The head of the European Medicines Agency said on Wednesday that there was “no evidence” to support the restriction of the use of AstraZeneca’s coronavirus vaccine in any population, as Germany has now done amid concerns about rare blood clots in people who received the shot.
But EMA’s CEO Emer Cooke said her Amsterdam-based agency will continue to study reports on new cases as they come in and will provide a further evaluation next week.
On Tuesday, an independent panel of vaccine experts in Germany said that AstraZeneca shots should not be routinely given to people under the age of 60 due to an increase in reported cases of unusual blood clots in the days after vaccination.
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The German government followed the recommendation and said that the British-Swedish company’s vaccine would be a priority for people aged 60 and older, although exceptions can be made in consultation with doctors.
The move put the spotlight back on the European Medicines Agency, which approved the AstraZeneca vaccine in January and said earlier this month – after some European countries stopped using the blood clot fear – that the benefits of the vaccine outweigh the risks.
“According to current scientific knowledge, there is no evidence to support the restriction of the use of this vaccine in any population,” Cooke told reporters.
She said the agency’s assessment was based on 62 cases worldwide of unusual blood clots, including 14 deaths, reported to the EMA by March 22. These figures included a “significant” number of cases reported from Germany, but not all, she said.
German regulators said they had received 31 reports of rare blood clots in the heads of recipients of the AstraZeneca vaccine and nine deaths by March 29, which roughly doubled
Cooke said the EMA will include the German cases in its review “and they will form part of the ongoing evaluation of the committee, as well as any additional cases reported from other countries and regions.”
Based on the figures reported to the authority so far, there have been 4.8 cases of the rare blood clots per million doses of the AstraZeneca vaccine administered, she said.
“For the BioNTech vaccine, based on the same criteria, it was 0.2 cases per million,” Cooke added, referring to the shot that a German biotechnology company developed with the American pharmaceutical giant Pfizer. “And for the Moderna vaccine based on the same criteria, zero cases per million. But that probably reflects the fact that there is much less use of Moderna right now in Europe.”
She said EMA experts had so far not identified any underlying risk factors for blood clots or established a causal relationship with the AstraZeneca vaccine.
“The link is possible, and we can say no more than that right now,” Cooke said.
Among those affected by Germany’s decision to stop using the AstraZeneca vaccine in under-60s were tens of thousands of teachers, who had only recently been offered meetings for the shot.
The head of the German teachers’ union, Heinz-Peter Meidinger, described the decision as a “catastrophic setback” and demanded that school staff be offered a different type of vaccine instead.