Clear link between AZ vaccine and rare blood clots in the brain, EMA official told the newspaper

ROME (Reuters) – There is a link between AstraZeneca’s COVID-19 vaccine and very rare blood clots in the brain, but the possible causes are still unknown, a senior official at the European Medicines Agency (EMA) said in an interview published Tuesday. market.

ARCHIVE PHOTO: The AstraZeneca logo is reflected in a drop on a syringe needle in this illustration taken on November 9, 2020. REUTERS / Dado Ruvic / Illustration / Archive photo

“In my opinion we can say now, it is clear that there is an association with the vaccine. However, we still don’t know what causes this reaction, ”Marco Cavaleri, president of the EMA vaccine evaluation team, told Italian newspaper Il Messaggero, when asked about the possible relationship between the injection of AstraZeneca and cases of blood clots in the brain.

Cavaleri added that the EMA would say there is a link, although the regulator is probably not in a position to give an indication of the age of the people to whom the AstraZeneca injection should be given.

He did not provide evidence to support his comments.

AstraZeneca was not immediately available for comment. She said earlier that her studies found no increased risk of clots because of the vaccine.

The regulator has consistently stated that the benefits outweigh the risks when investigating 44 reports of an extremely rare brain coagulation disease known as cerebral venous sinus thrombosis (CVST) in 9.2 million people in the European Economic Area who received the AstraZeneca vaccine.

The World Health Organization also supported the vaccine.

The EMA said last week that its review had not identified any specific risk factors, such as age, sex or previous medical history of clotting disorders, for these very rare events. A causal link to the vaccine has not been proven, but it is possible and further analysis is continuing, the agency said.

A high proportion of reported cases affected young and middle-aged women, but this did not lead the EMA to conclude that this cohort was particularly at risk with the injection of AstraZeneca.

The EMA is due to update its investigation on Wednesday.

Some countries, including France, Germany and the Netherlands, have suspended the use of the vaccine in younger people while investigations continue.

Scientists are exploring several possibilities that may explain the extremely rare blood clots that occurred in individuals in the days and weeks after receiving the AstraZeneca vaccine.

European researchers have put forward a theory that the vaccine triggers an unusual antibody in some rare cases; others are trying to understand whether the cases are related to birth control pills.

But many scientists say there is no definitive evidence and it is not clear whether or why the AstraZeneca vaccine would cause a problem not shared by other vaccines that target a similar part of the coronavirus.

In a separate interview, Armando Genazzani, a member of the EMA’s Committee for Medicinal Products for Human Use (CHMP), told La Stampa daily that it was “plausible” that blood clots were related to the AstraZeneca vaccine.

Reporting by Giulia Segreti; Editing by Giles Elgood

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