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UPDATE 3-EU drug regulator says up to countries to decide how to handle AstraZeneca

Wed, 07th Apr 2021 16:07

(Adds Italy recommending AstraZeneca only for over-60s)

AMSTERDAM, April 7 (Reuters) - European countries should
make their own decisions about how to handle the risk of rare
blood clots from AstraZeneca's COVID-19 vaccine, based
on prevailing infection rates and the availability of
alternative vaccines, the EU drugs regulator said on Wednesday.

Several countries in Europe have announced restrictions on
the use of the AstraZeneca vaccine in younger people, after a
link was found to very rare blood clots, mostly in women under
60 years of age within two weeks of vaccination.

Italy was the latest to change its policy on Wednesday,
saying that from now on it would recommend the use of
AstraZeneca only for those over the age of 60.

But the European Medicines Agency (EMA) held back from
issuing guidelines, saying countries would have to assess the
balance of risks themselves, based on local conditions that vary
widely across the bloc.

"We try to provide as much information as possible on the
benefits and the risks we have identified, and based on that and
the pandemic situation in a member state - the infection rate,
the availability of different vaccines - the different member
states can take different decisions on who to vaccinate," EMA
Executive Director Emer Cooke told a briefing.

Cooke said the risk of dying from COVID-19 was "much
greater" than the risk of mortality from rare side effects.

"It is very important that we use the vaccines we have to
try and beat this pandemic," she said.

Sabine Straus, chair of the EMA's safety committee, said
side-effects were not unexpected as vaccines were rolled out on
a large scale.

The EMA has received reports of 169 cases of a rare brain
blood clot known as cerebral venous sinus thrombosis (CVST), as
of April 4, Straus said. That's out of 34 million doses of the
shot administered in the European Economic Area.

There have also been three cases of blood clots with low
platelets after the use of the Johnson & Johnson shot,
Peter Arlett, head of data analytics and methods task force,
said. Experts told Reuters it was too early to say whether these
events were connected to the vaccine.
(Reporting by Anthony Deutsch, Toby Sterling and Bart Meijer in
Amsterdam, Kate Kelland in London
Writing by Josephine Mason
Editing by Kevin Liffey and Peter Graff)

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