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UPDATE 1-EU's drug regulator backs AstraZeneca vaccine after safety investigation

Thu, 18th Mar 2021 16:31

(Adding details)

AMSTERDAM, March 18 (Reuters) - The EU's drug watchdog said
on Thursday it is still convinced the benefits of AstraZeneca's
COVID-19 vaccine outweigh the risks following an
investigation into reports of blood disorders that prompted more
than a dozen nations to suspend its use.

The news came as the European Medicines Agency (EMA)
director Emer Cooke said the watchdog could not definitively
rule out a link between blood clot incidents and the vaccine in
its investigation into 30 cases of a rare blood clotting
condition.

But she said in a briefing the "clear" conclusion of the
review was that the vaccine "benefits in protecting people from
COVID-19 with the associated risk of death or hospitalisation
outweighs the possible risks."

The agency will however update its guidance to include an
explanation about the potential risks on both the patient
leaflet and in the information for healthcare professionals, she
said.

"This is a safe and effective vaccine," said Cooke.

The agency has been under growing pressure to clear up
safety concerns after a small number of reports in recent weeks
of bleeding, blood clots and low platelet counts in people who
have received the shot.

The agency's review covering 5 million people, included 30
cases of unusual blood disorders in people in the European
Economic Area (EEA), which links 30 European countries.

The EMA's focus and primary concern has been on cases of
blood clots in the head, a rare condition that's difficult to
treat called cerebral venous thrombosis (CVT) or a subform known
as cerebral venous sinus thrombosis (CVST).

More than 45 million of the shots have been administered
across the EEA.

At least 13 European countries, including France, Germany
and Italy, have stopped administering the shot pending the
review.

Britain's medicines regulator said on Thursday it was
investigating five cases of CVST among people given
AstraZeneca's vaccine but it reaffirmed that the benefits of the
shot far outweighed any possible risks.

The World Health Organization also this week reaffirmed its
support for the shot.

AstraZeneca has said a review covering more than 17 million
people who had received its shots in the EU and Britain had
found no evidence of an increased risk of blood clots.

Many governments have said the decision to pause
inoculations was out of an abundance of caution.

But experts have warned the political interference could
undermine public confidence and hobble the bloc's slow
vaccination campaign as governments struggle to tame more
infectious variants.

The bloc's vaccine roll-out has lagged the United States and
former EU member Britain.

(Reporting by Anthony Deutsch and Toby Sterling in Amsterdam
and Ludwig Burger in Frankfurt
Writing by Josephine Mason in London;Editing by Elaine
Hardcastle)

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