A senior official at Europe’s medicines regulator has said there is a clear “association” between AstraZeneca’s COVID-19 vaccine and very rare blood clots in the brain, though the direct cause of the clots is still unknown.

The European Medical Agency (EMA) said in a statement after the comments by Marco Cavaleri, chair of its vaccine evaluation team, that it was still conducting a review of the vaccine and expected to announce its findings on Wednesday or Thursday.

An AstraZeneca spokesman declined to comment on Cavaleri’s remarks, which he made in an interview with Italian newspaper Il Messagero that was published on Tuesday.

The EMA has said the benefits of the AstraZeneca shot outweigh any risks, and the World Health Organization has backed the vaccine. AstraZeneca has said previously that its studies have found no higher risk of clots because of its vaccine.

The EMA is investigating 44 reports of an extremely rare brain clot known as cerebral venous sinus thrombosis (CVST) out of 9.2 million people who have received the vaccine in the European Economic Area, which comprises European Union member states and Iceland, Liechtenstein and Norway.

In response to Cavaleri’s comments, the Amsterdam-based EMA said in a statement on Tuesday: “EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has not yet reached a conclusion and the review (of any possible link) is currently ongoing.”

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 the blood clots were correlated with the AstraZeneca vaccine.

A high proportion of the reported cases are in young or middle-aged women, but that has not led the EMA to conclude this group is at particular risk./Reuters

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