EU Medicines Regulatory Agency Finds Possible Link Between AstraZeneca Vaccine And Blood Clots

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Europe’s medicines regulator on Wednesday, April 7, 2021, announced a possible link between the coronavirus vaccine developed by AstraZeneca and the University of Oxford and rare blood clotting issues in adults who received the shot.

It comes after a review of all currently available evidence into extremely rare cases of unusual blood clots in some vaccinated people.

The Oxford-AstraZeneca shot has been dogged by safety concerns in recent weeks, with several European countries briefly suspending their use of the vaccine last month.

The European Medicines Agency said on March 31 that it had found the shot to be safe and effective, but added it could not rule out the possibility of a causal link between the vaccine and clotting events so would continue to investigate.

The World Health Organization, the U.K.’s medicines regulator, and the International Society on Thrombosis and Hemostasis have all said that the benefits of administering the Oxford-AstraZeneca shot far outweigh the risks.

AstraZeneca has previously said its studies have found no higher risk of blood clots as a result of its vaccine.

Most countries have since resumed use of the shot but many have suspended inoculations across certain age groups.

A senior official at Europe’s medicines regulator reportedly said Tuesday that there is a clear “association” between the Oxford-AstraZeneca vaccine and very rare blood clots in the brain, though the direct cause was not yet known.

In an interview with the Italian newspaper, Il Messaggero published Tuesday, Marco Cavaleri, chair of the EMA’s vaccine evaluation team, said: “In my opinion, we can now say it, it is clear that there is an association with the vaccine. However, we still do not know what causes this reaction.”

The EMA subsequently denied 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 paused

The Medicines and Healthcare products Regulatory Agency, the body that approved the Oxford-AstraZeneca vaccine for use in the U.K., has been looking at the data following a handful of reports — both in the U.K. and in continental Europe — of serious but rare blood clots, some of which have been fatal.

A U.K. trial of the Oxford-AstraZeneca vaccine on children had already been paused while the medicines regulator investigated a possible link between the shot and the blood clotting disorders, specifically, cases of blood clots in veins within the brain, known as cerebral venous sinus thrombosis (CVST) as well as thrombocytopenia (low levels of blood platelets which help the blood to clot).

The U.K. government noted that, up to and including March 24, there had been 22 reports of CVST and 8 reports of other thrombosis events with low platelets, out of a total of 18.1 million doses of the AstraZeneca vaccine (a two-dose shot) given by that date.

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