At the pharmacy, syringes are filled with Astrazeneca’s vaccine.
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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 blood clotting problems in adults who received the injection
It comes after a review of all the currently available evidence for extremely rare cases of unusual blood clots in some vaccinated people.
Emer Cooke, executive director of the European Medicines Agency, said in a televised press conference that the regulator’s safety committee “has confirmed that the benefits of the AstraZeneca vaccine in preventing Covid-19 generally outweigh the risks of side effects. . “
The EMA’s safety committee “concluded after a very in-depth analysis that the reported cases of unusual blood clotting after vaccination with the AstraZeneca vaccine should be listed as potential side effects of the vaccine,” Cooke said.
“A plausible explanation for these rare side effects is an immune response to the vaccine, similar to that seen in patients treated with heparin,” she said, noting that it is called heparin-induced thrombocytopenia.
AstraZeneca’s shares fell about 0.8% during afternoon deals in London.
The Oxford-AstraZeneca shot has been haunted by safety concerns in recent weeks, with several European countries curtailing their use of the vaccine last month.
The EMA said on March 31 that it had determined the shot was safe and effective, but added that it could not rule out the possibility of a causal link between the vaccine and clotting events, so it would continue to investigate.
The World Health Organization, the UK Medicines Regulator and the International Society on Thrombosis and Hemostasis have all said that the benefits of administering the Oxford AstraZeneca injection far outweigh the risks.
AstraZeneca has previously said that its studies have not found a higher risk of blood clots as a result of the vaccine.
Most countries have since resumed use of the shot, but many have suspended vaccinations for certain age groups.
A senior official at the European medicines regulator said Tuesday that there is a clear “link” between the Oxford AstraZeneca vaccine and very rare blood clots in the brain, although the immediate cause was not yet known.
In an interview published Tuesday with the Italian newspaper Il Messaggero, Marco Cavaleri, chairman of the EMA’s vaccine evaluation team, said: “In my opinion we can say it now, it is clear that there is a connection with the vaccine. causes. “
The EMA subsequently denied in a statement to Agence France-Presse having established a link between the injection of Oxford-AstraZeneca and rare blood clots.
UK vaccine study in children interrupted
The Medicines and Healthcare products Regulatory Agency, 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 continental Europe – of serious but rare blood clots , some of which were fatal.
A UK trial of the Oxford AstraZeneca vaccine in children had already been interrupted while the regulator of drugs was investigating a possible link between the injection and the blood clotting disorders, in particular cases of blood clots in veins in the brain known as cerebral venous sinus thrombosis (CVST) as well as thrombocytopenia (low number of platelets that help the blood to clot).
The UK Government noted that there were 22 reports of CVST and 8 reports of other low platelet thrombosis events through March 24, out of a total of 18.1 million doses of the AstraZeneca vaccine (one two-dose injection) given on that date.
People are waiting at a vaccination center in Cologne, Germany, on April 5, 2021.
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“We need to know more about the people affected and understand exactly how the diseases originated, while many other questions remain unanswered at this point,” said Adam Finn, a professor of pediatrics at Bristol University, UK, ahead of Wednesday’s announcement. .
“However, there are some things that are very clear. The first is that these cases are indeed very rare. The second is that the vaccines that are available and in use in the UK prevent COVID from being very effective,” said Finn.
“Basically, if you are currently being offered a dose of Oxford AstraZeneca vaccine, your chances of staying alive and staying healthy will increase if you take the vaccine and decrease if you don’t.”
– CNBC’s Holly Ellyatt contributed to this report.