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Update on AstraZeneca blood clot review coming this week, EU drug regulator says

The European medicines watchdog expects to hold a press conference this week updating the public on its review of rare blood clotting cases in people who have received the AstraZeneca COVID-19 vaccine, a spokeswoman said on Tuesday.

In an emailed response to questions, a spokeswoman for the European Medicines Agency said its pharmaceuticals risk assessment committee “had not reached a conclusion” in its current review of the vaccine’s safety, and it expects to hold a press briefing “as soon as the review is finalized,” either on April 7 or April 8.

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The regulator has consistently said the benefits outweigh the risks as it investigates 44 reports of an extremely rare brain clotting ailment known as cerebral venous sinus thrombosis (CVST) out of 9.2 million people in the European Economic Area who have received the AstraZeneca vaccine.

The World Health Organization has also backed the vaccine.

As has Canada.

The country’s National Advisory Committee on Immunization (NACI) has since recommended the vaccine not be given to those under the age of 55 due to blood clot concerns — but out of sheer caution. However, the agency stands by the vaccine for those above that age, saying the benefits still clearly outweigh the risk.

To date, no cases of these events have been reported in Canada.

Click to play video: EU agency: Oxford-AstraZeneca shot is ‘safe and effective’

Earlier Tuesday, the chair of the vaccine evaluation team at the EMA, Marco Cavaleri, reportedly told an Italian daily, Il Messaggero, that there is a link between the vaccine and very rare blood clots in the brain, though the possible causes are still unknown.

Cavaleri said he was speaking of his own opinion. He provided no evidence to support his comment.

The EMA refuted that conclusion soon after, saying no determination had been reached in the vaccine’s safety review.

An AstraZeneca spokesman declined to comment on the matter to Reuters.

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Last week, the EMA said that its review had, at present not identified any specific risk factors, such as age, gender or a previous medical history of clotting disorders, for these very rare events. A causal link with the vaccine is not proven, but is possible and further analysis is continuing, the agency said.

A high proportion among the reported cases affected young and middle-aged women but that did not lead EMA to conclude this cohort was particularly at risk from AstraZeneca’s shot.

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

Click to play video: WHO says continue to use AstraZeneca vaccine as several countries temporarily pause distribution

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

European investigators have put forward one theory that the vaccine triggers an unusual antibody in some rare cases; others are trying to understand whether the cases are linked with birth control pills.

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

— with Global News files 

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