Last checked at 
* EMA says review of AstraZeneca vaccine is ongoing
* Review findings expected on Wednesday or Thursday - EMA
* France, Germany, Netherlands, suspend AZ in younger people
* Another EMA committee member says link "plausible"
(Adds EMA saying review is ongoing)
ROME, April 6 (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 for the European Medicines Agency (EMA) said in an
interview published on Tuesday.
However, the EMA later said in a statement that its review
of the vaccine was ongoing and it expected to announce its
findings 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 evaulation 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.
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 suspending the use of the vaccine in younger
people while the investigations continue.
REVIEW ONGOING
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."
The EMA said last week 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 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.
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 vaccine.
One theory suggests that the vaccine triggers an unusual
antibody in some rare cases; other investigators are looking
into a possible link 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.
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.
(Reporting by Giulia Segreti; Additonal reporting by Toby
Sterling and Anthony Deutsch in Amsterdam; Editing by Giles
Elgood and Gareth Jones)
