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EU drug regulator finds possible link between AstraZeneca Covid vaccine and blood clots

Syringes are filled with Astrazeneca’s vaccine at the pharmacy.

Christopher Neundorf | picture alliance | Getty Images

LONDON – Europe’s 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 coagulation in adults who received the shot.

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

The Oxford-AstraZeneca shot has been rejected by security 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 safe and effective, but added that it could not rule out the possibility of a causal link between the vaccine and coagulation events, so it continued to investigate.

The World Health Organization, the UK Drug Regulator and the International Society on Thrombosis and Hemostasis have all said the benefits of administering Oxford-AstraZeneca shots far outweigh the risks.

AstraZeneca has previously said that its studies have not found any higher risk of 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 Europe’s drug regulator reportedly said on Tuesday that there is a clear “link” between the Oxford-AstraZeneca vaccine and very rare blood clots in the brain, although the direct cause was not yet known.

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

The EMA subsequently denied that it had established a link between the Oxford-AstraZeneca shot and rare blood clots in a statement to Agence France-Presse.

UK vaccine study in children stopped

The Regulatory Agency for Medicines and Health Products, the body that approved the Oxford-AstraZeneca vaccine for use in the UK, has looked at the data after a handful of reports – both in the UK and in continental Europe – on severe but rare blood clots. , some of which have been fatal.

A UK trial of the Oxford-AstraZeneca vaccine in children had already been halted, while the drug regulator investigated a possible link between the shot and blood clots, especially cases of blood clots in veins in the brain, known as cerebral venous sinus thrombosis (CVST) as well as thrombocytopenia ( low levels of platelets, which help the blood to clot).

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

People are waiting in a vaccination center in Cologne, Germany on April 5, 2021.

Marius Becker | picture alliance | Getty Images

“We need to know more about the people affected and we need to understand exactly how the diseases originated, while many other questions remain unanswered at this time,” said Adam Finn, Professor of Pediatrics at Bristol University in the UK. ahead of Wednesday’s announcement.

“However, there are some things that are very clear. The first is that these cases are very rare. The second is that the vaccines that are available and in use in the UK prevent COVID very effectively,” Finn said.

“In short, if you are currently offered a dose of Oxford-AstraZeneca vaccine, your chances of staying alive and feeling good if you take the vaccine and will go down if you do not.”

– CNBC’s Holly Ellyatt contributed to this report.

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