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.
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.
"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," Cavaleri said, without giving evidence to support his comments.
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.
Cavaleri said the EMA would say in its review that there is a link, but was not likely to give an indication this week on which age groups should or should not get the AstraZeneca shot.
Some countries, including France, Germany and the Netherlands, have suspended the use of the vaccine in younger people while the investigations continue.
The World Health Organization expects there will be no reason to change its assessment that the benefits of the AstraZeneca vaccine against COVID-19 outweigh any risks, its regulatory director said on Tuesday.
The WHO is closely studying the latest data alongside European and other regulators, in light of reports of blood clots among people who have been vaccinated, said Rogerio Gaspar, WHO director of regulation and prequalification.
The European Medical Agency (EMA) said in a statement after the comments by Marco Cavaleri that it was still conducting a review of the vaccine and expected to announce its findings on Wednesday or Thursday.
Gaspar said the WHO expects to reach a fresh assessment on Wednesday or Thursday, after its own vaccine safety advisory group meets, but does not believe there will be a reason to change its advice that the benefits outweigh any risks.
"What we can say is that the appraisal that we have for the moment - and this is under consideration by the experts - is that the benefits-risk assessment for the vaccine is still largely positive," he told a Geneva news conference.
"We continue to see a number of events that are rare events linking thrombocytopenia to thromboembolic events and those rare events are now being categorised in terms of the diagnostics, in terms of the population, in terms of the distribution within the population," he said.
WHO was in touch with various national and regional expert committees that will decide on the vaccine's regulatory status, Gaspar said.
"For the time being there is no evidence that the benefit-risk assessment for the vaccine needs to be changed," he added.
Źródło: TVN24 News in English, Reuters