EMA EXEC AFFIRMS LINK BETWEEN ASTRAZENECA VACCINE AND BLOOD CLOTS

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 for the European Medicines Agency (EMA) said in an interview published, Reuters reported.

However, the EMA later said in a statement that its review of the vaccine was ongoing and its findings are expected to be announced on Wednesday or Thursday. An AstraZeneca spokesman declined to comment on the matter.

“In my opinion, we can now say it, it is clear that there is an association (of the brain blood clots) with the vaccine. However, we still do not know what causes this reaction,” Marco Cavaleri, chair of the vaccine evaluation team at the EMA, told Italian daily Il Messagero. Cavaleri provided no evidence to support his comment.

The EMA has repeatedly said the benefits of the AstraZeneca shot 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 vaccine.

The World Health Organization has also backed the vaccine. The AstraZeneca vaccine is based on a modified chimpanzee adenovirus vector, ChAdOx1, developed at Oxford University and is one of several adenovirus-vector COVID-19 vaccines. The current vaccine rollout represents the first use of viral vector vaccines on such a global scale.

AstraZeneca has said previously its studies have found no higher risk of clots because of its vaccine. Cavaleri said the EMA would say in its review that there is a link but was not likely to give an indication this week regarding the age of individuals to whom the AstraZeneca shot should be given.

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

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