Sunday, October 17

EU Drug Agency Denies Has Already Found a Causal Link Between AstraZeneca Vaccine and Blood Clots | Coronavirus


The European drug regulator has denied that it has already established a causal connection between the Oxford / AstraZeneca vaccine and a rare blood clotting syndrome, after a senior agency official said there was a link.

In a statement to Agence France-Presse, the European Medicines Agency (EMA) said Tuesday that it “had not yet reached a conclusion and the review is ongoing,” adding that it expected to announce its findings on Wednesday or Thursday.

Marco Cavaleri, director of vaccines at the EMA, had previously told the Italian newspaper Il Messaggero that, in his opinion, “we can say it now, it is clear that there is a link with the vaccine … But we do not yet know what causes this reaction” .

Concerns about rare but serious blood clotting events in a small number of recipients have lingered on the vaccine in recent weeks, with more than a dozen European countries briefly suspending its use last month pending an EMA investigation.

The regulator later said the vaccine was safe and effective, but added that it could not definitively rule out a connection between the injection and the rare clotting events, so it was continuing to investigate.

The World Health Organization, the EMA and the Medicines and Health Products Regulatory Agency (MHRA) have said that people should continue to take it because the benefits to prevent Covid-19 infection and its complications continue to far outweigh any risks.

Since then, most countries have resumed inoculation with the AstraZeneca injection, but several, including France, Germany, Italy, France, Spain, the Netherlands, and Canada, have discontinued its use in people under the age of 55, 60 or 65 years.

The EMA is investigating 14 deaths among jab recipients that had been reported as of March 22 and are linked to unusual blood clots in the brain, known as cerebral venous sinus thrombosis (CVST), accompanied by a low platelet count. . A high proportion of the reported cases affected were young and middle-aged women.

“We are trying to get an accurate picture of what is happening, to define in detail this syndrome due to the vaccine,” Cavaleri told the newspaper. “Among those vaccinated, there are more cases of cerebral thrombosis … among young people than you would expect.”

The UK regulator, the MHRA, has also reported 22 cases of CVST, as well as eight reports of other blood clotting problems with low platelets, up to and including March 24. Of these 30 reports, the agency has said that seven people had died.

Channel 4 reported Monday that the MHRA was considering restricting the vaccine to those under 30 and could make an announcement Tuesday, though MHRA Executive Director Dr. June Raine said a decision had not yet been made. .

Professor Neil Ferguson of Imperial College London told the BBC on Monday that the clots raised questions about whether young people should receive the jab.

Ferguson said: “There is growing evidence that there is a rare risk associated particularly with the AstraZeneca vaccine, but it may be associated with a lower level with other vaccines, of these unusual blood clots with low platelet counts.

“It seems the risk is related to age, possibly, but the data is weaker on this, related to sex.”

Professor Paul Hunter, a medical microbiologist at the University of East Anglia, told the BBC that “the chances of a random association are very, very low.”


www.theguardian.com

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