Syringes are filled with the vaccination of Astrazeneca in the pharmacy.
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LONDON – The European drug regulator announced on Wednesday a possible link between the coronavirus vaccine developed by AstraZeneca and the University of Oxford, and rare problems with blood clotting in adults who received the shot..
This comes after a review of all available evidence in extremely rare cases of unusual blood clots in some vaccines.
Emer Cooke, executive director of the European Medicines Agency, told a news conference that the regulator’s safety committee had confirmed that the benefits of the AstraZeneca vaccine to prevent Covid-19 outweighed the risks of side effects. weigh.’
The EMA’s safety committee “after a very in-depth analysis concluded that the reported cases of unusual blood clotting after vaccination with the AstraZeneca vaccine should be listed as possible side effects of the vaccine,” Cooke said.
“A plausible explanation for these rare side effects is an immune response to the vaccine similar to one seen in patients treated with heparin,” she said, noting that it is called treparosition by heparin.
AstraZeneca’s shares fell by about 0.8% during the afternoon deals in London.
The Oxford-AstraZeneca shot has been plagued by safety considerations in recent weeks, and several European countries briefly suspended use of the vaccine last month.
The EMA said on March 31 that the shot was safe and effective, but added that it could not rule out the possibility of a causal link between the vaccine and coagulation events.
The World Health Organization, the UK Drug Regulator and the International Society for Thrombosis and Hemostasis have all said that the benefits of administering the Oxford-AstraZeneca far outweigh the risks.
AstraZeneca had earlier said its studies found no higher risk for blood clots due to the vaccine.
Most countries have since resumed use of the shot, but many have suspended vaccinations in certain age groups.
A senior official at the European Medicines Regulatory Agency said on Tuesday that there was a clear “link” between the Oxford-AstraZeneca vaccine and very rare blood clots in the brain, although the immediate cause is not yet known. was not.
In an interview with the Italian newspaper Il Messaggero published on Tuesday, Marco Cavaleri, chairman of the EMA’s evaluation team, said: “In my opinion we can say now, it is clear that there is a link with the vaccine “do not know what is causing this reaction.”
The EMA subsequently denied that it had established any link between the Oxford-AstraZeneca shot and rare blood clots in a statement to Agence France-Presse.
UK vaccine trial in children interrupted
The Regulatory Agency of Medicines and Healthcare Products, the body that approved the Oxford-AstraZeneca vaccine for use in the UK, looked at the data from a handful of reports – both in the UK and in continental Europe – of severe but rare blood clots. some of which were fatal.
A UK trial of the Oxford-AstraZeneca vaccine for children has already been suspended while the drug regulator investigated a possible link between the shot and the blood clotting disorders, especially cases of blood clots in the arteries in the brain known as cerebral venous sinus thrombosis . (CVST) as well as thrombocytopenia (low levels of platelets that help the blood to clot).
The UK government noted that as of March 24, there were 22 reports of CVST and 8 reports of other low-platelet thrombotic events, out of a total of 18.1 million doses of AstraZeneca vaccine (a two-dose shot) by that date. gave.
People are waiting for April 5, 2021 in a vaccination center in Cologne, Germany.
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“We need to know more about the people affected and we need to understand exactly how the diseases originated, while many other questions are currently unanswered,” said Adam Finn, a professor of pediatrics at Bristol -university, said. .
“However, there are many things that are very clear. The first is that these cases are indeed very rare. The second is that the vaccines available and used in the UK appear to be very effective in COVID,” Finn said.
“In short, if you are currently offered a dose of Oxford-AstraZeneca vaccine, your chances of staying alive will increase if you take the vaccine, and will decrease if you do not.”
CNBC’s Holly Ellyatt contributed to this report.