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The benefits of taking AstraZeneca’s COVID-19 vaccine still outweigh the small potential risk of blood clots, Europe’s top drug regulator has reiterated following Germany’s decision to stop administering the jab to most people under 60.
The cities of Berlin and Munich—swiftly followed by the rest of Germany—announced on Tuesday that they would no longer routinely offer the AstraZeneca vaccine to under-60s, as a “precaution” triggered by ongoing concerns over the clotting issue.
Dozens of people across Europe have developed unusual clotting in the head after receiving AstraZeneca shots. In Germany, there have been 31 cases—that’s a statistically minuscule proportion of the 2.7 million AstraZeneca doses that have been given in the country—but nine people have died and the reports keep appearing. Almost all the cases have involved women between the ages of 20 and 63.
“In sum it’s about weighing the risk of a side effect that is statistically small, but needs to be taken seriously, and the risk of falling ill with Corona,” Health Minister Jens Spahn said Tuesday.
But Germany is now firmly in the grips of a third COVID-19 wave and hundreds of people are dying from that each day. As far as the European Medicines Agency (EMA) is concerned, the risk-benefit analysis still comes down in AstraZeneca’s favor.
“EMA is 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 agency, which is in charge of assessing COVID-19 vaccines for emergency use, said in a Wednesday statement.
Hundreds of thousands of people in Germany have avoided turning up for their AstraZeneca jabs in recent weeks. That’s unsurprising given the topsy-turvy run of events. The authorities there first said it was unsuitable for over-65s, then reversed that decision, later suspending its rollout for everyone because of the clotting fears, before reversing that decision following reassurances from the EMA.
Now, with the official German advice having swung back to skepticism, the only people under 60 who can get the AstraZeneca vaccine in Germany are those who are at a high risk of getting seriously ill with COVID, and who have expressly consented to getting the jab despite the potential risk.
The EMA’s safety committee is meeting Wednesday to discuss the issue. So far, the agency said, its review “has not identified any specific risk factors, such as age, gender or a previous medical history of clotting disorders, for these very rare events.”
“A causal link with the vaccine is not proven, but is possible and further analysis is continuing,” it added.
AstraZeneca itself said in a late-Tuesday statement that tens of millions of people around the world had received its vaccine, and “the extensive body of data from two large clinical datasets and real-world evidence demonstrate its effectiveness, reaffirming the role the vaccine can play during this public health crisis.”
The company said it was scouring its database to figure out if the blood-clot cases were occurring “any more commonly than would be expected naturally in a population of millions of people,” and that it “will continue to work with German authorities to address any questions they may have.”
Canada’s vaccine authority has also recommended no longer giving the AstraZeneca vaccine to under-55s for the time being, based on the European clotting reports.
