EU drug regulator: Unusual blood clot 'very rare AstraZeneca side effect'
The EU's medicines regulator says unusual blood clots should be listed as a very rare side effect of the AstraZeneca vaccine for Covid-19.
After a study into dozens of cases in the EU, the European Medicines Agency (EMA) concluded the benefits of the vaccine outweighed the risk.
There was no definite causal link and though most cases were in women under 60, they also occurred in men.
It studied 86 blood clot cases. The EU has vaccinated over 20 million people.
At a press briefing, EMA executive director Emer Cooke said that the combination of blood clots and low blood platelets was very rare but was seen in "all ages, and in men and women", and there was no available evidence of "specific risk factors such as age, gender, or previous medical history of clotting disorders".
"Our safety committee... has confirmed that the benefits of the AstraZeneca vaccine in preventing Covid-19 overall outweigh the risks of side effects," she said.
Ms Cooke added: "This vaccine has proven to be highly effective - it prevents severe disease and hospitalisation, and it is saving lives."
AstraZeneca has said its studies have found no causal link with blood clots.
The EMA said that one plausible explanation was an "immune response, leading to a condition similar to one seen sometimes in patients treated with heparin (heparin induced thrombocytopenia, HIT)".
EU health ministers will begin a meeting shortly to discuss the findings.
The EMA evaluates and supervises medicine use for all of the EU, including drug approval.
However, this does not mean there has been unity on tackling Covid-19.
Countries within the bloc have diverged widely on vaccination campaigns and on the use of AstraZeneca.