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* Reiterates that benefits outweigh any risks
* Says no age or sex group at particular risk
* Also cites 'remote possibility' of blood clotting
* EMA heard panel of independent experts
(Add data on cases, assessment)
March 31 (Reuters) - Europe's medicines regulator reiterated
its backing of AstraZeneca's COVID-19 vaccine, saying
no particular group of age, sex or a previous medical history
was especially susceptible to blood clotting after receiving the
shot.
However, while repeating that the vaccine's benefits
outweigh risks, it cautioned that people should be aware of the
"remote possibility" of rare blood clots occurring, and must
seek immediate medical attention in case of symptoms.
"A causal link with the vaccine is not proven, but is
possible and further analysis is continuing," the European
Medicines Agency (EMA) said in a statement. (https://bit.ly/3m6d2M9)
EMA issued the statement after a hearing with a panel of
independent external experts on Monday.
It spoke after several countries including Canada, Germany,
France and Spain limited use of the drugmaker's shot, after
reports of a rare clotting condition following vaccination.
Investigations by EMA and several national authorities in
the EU continue, after initial probes deemed the vaccine safe
for use following reports of a brain clotting ailment known as
cerebral venous sinus thrombosis (CVST).
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.
Women were generally more prone to CVST than men and twice
as many women as men had received AstraZeneca's shot in the EU
so far, said EMA's head of safety monitoring, Peter Arlett.
"This is why at this stage it is difficult to disentangle
why there has been a preponderance of reports of this very rare
potential side effect in younger women in particular," he added.
EMA had analysed 62 such cases globally, consulting also
with regulators in India, Brazil and Britain, and 44 of the
cases had occurred in the European Economic Area (EEA).
It had looked into 14 deaths, though not all were associated
with CVST, said Arlett. About 9.2 million people in the EEA had
received the shot by the assessment's cut-off date of March 22.
Arlett did acknowledge the blood-clotting incidence rate was
higher than what was normally expected in the young and
middle-aged. Though he did not quantify the difference, he said
it did not justify a change in recommendation.
"If we look into individuals under 60, we do see more cases
of (CVST) than we would expect to see from the background rate,"
said Arlett.
Germany vaccine oversight body PEI said on Tuesday it had
registered 31 cases of CVST, which resulted in nine deaths, out
of some 2.7 million people who have received the AstraZeneca
vaccine.
EMA said a few of the German cases happened after its
cut-off date and had not yet been included in its analysis.
(Reporting by Pushkala Aripaka in Bengaluru, Ludwig Burger in
Frankfurt, Josephine Mason in London; Editing by Shinjini
Ganguli, Rashmi Aich and Mark Heinrich)
