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WRAPUP 4-Germany, Italy, France hit pause on AstraZeneca amid safety fears, disrupting EU shots

Mon, 15th Mar 2021 10:46

(Adds quote, U.S. probe)

* Italian prosecutor seizes batch of vaccine after man dies

* Decisions to pause shots 'look baffling', scientist says

* Denmark and Netherlands give more details of clotting
issue

By Thomas Escritt and Stephanie Nebehay

BERLIN/GENEVA, March 15 (Reuters) - Germany, France and
Italy said on Monday they would hit pause on AstraZeneca
COVID-19 shots after several countries reported possible serious
side-effects, throwing Europe's already struggling vaccination
campaign into disarray.

Denmark and Norway stopped giving the shot last week after
reporting isolated cases of bleeding, blood clots and a low
platelet count. Iceland and Bulgaria followed suit and Ireland
and the Netherlands announced suspensions on Sunday.

The moves by some of Europe's largest and most populous
countries will deepen concerns about the slow rollout of
vaccines in the region, which has been plagued by shortages due
to problems producing vaccines, including AstraZeneca's.

Germany warned last week it was facing a third wave of
infections, Italy is intensifying lockdowns and hospitals in the
Paris region are close to being overloaded.

German Health Minister Jens Spahn said that although the
risk of blood clots was low, it could not be ruled out.

"This is a professional decision, not a political one,"
Spahn said adding he was following a recommendation of the Paul
Ehrlich Institute, Germany's vaccine regulator.

France said it was suspending the vaccine's use pending an
assessment by the EU medicine regulator due on Tuesday. Italy
said its halt was a "precautionary and temporary measure"
pending the regulator's ruling.

Austria and Spain have stopped using particular batches and
prosecutors in the northern Italian region of Piedmont earlier
seized 393,600 doses following the death of a man hours after he
was vaccinated. It was the second region to do so after Sicily,
where two people had died shortly after having their shots.

The World Health Organization appealed to countries not to
suspend vaccinations against a disease that has caused more than
2.7 million deaths worldwide.

"As of today, there is no evidence that the incidents are
caused by the vaccine and it is important that vaccination
campaigns continue so that we can save lives and stem severe
disease from the virus," WHO spokesman Christian Lindmeier said.

The United Kingdom said it had no concerns, while Poland
said it thought the benefits outweighed any risks.

The EMA has said that as of March 10, a total of 30 cases of
blood clotting had been reported among close to 5 million people
vaccinated with the AstraZeneca shot in the European Economic
Area, which links 30 European countries.

Michael Head, a senior research fellow in global health at
the University of Southampton, said the decisions by France,
Germany and others looked baffling.

"The data we have suggests that numbers of adverse events
related to blood clots are the same (and possibly, in fact
lower) in vaccinated groups compared to unvaccinated
populations," he said, adding that halting a vaccination
programme had consequences.

"This results in delays in protecting people, and the
potential for increased vaccine hesitancy, as a result of people
who have seen the headlines and understandably become concerned.
There are no signs yet of any data that really justify these
decisions.”

"UNUSUAL" SYMPTOMS

AstraZeneca's shot was among the first and cheapest to be
developed and launched at volume since the coronavirus was first
identified in central China at the end of 2019 and is set to be
the mainstay of vaccination programmes in much of the developing
world.

Thailand announced plans on Monday to go ahead with the
Anglo-Swedish firm's shot after suspending its use on Friday but
Indonesia said it would wait for the WHO to report.

The WHO said its advisory panel was reviewing reports
related to the shot and would release its findings as soon as
possible. But it said it was unlikely to change its
recommendations, issued last month, for widespread use,
including in countries where the South African variant of the
virus may reduce its efficacy.

The EMA has also said there was no indication the events
were caused by the vaccination and that the number of reported
blood clots was no higher than seen in the general population.

The handful of reported side-effects in Europe have upset
vaccination programmes already under pressure over slow rollouts
and vaccine scepticism in some countries.

The Netherlands said on Monday it had seen 10 cases of
possible noteworthy adverse side-effects from the AstraZeneca
vaccine, hours after the government put its vaccination
programme on hold following reports of potential side-effects in
other countries.

Denmark reported "highly unusual" symptoms in a 60-year-old
citizen who died from a blood clot after receiving the vaccine,
the same phrase used on Saturday by Norway about three people
under the age of 50 it said were being treated in hospital.

"It was an unusual course of illness around the death that
made the Danish Medicines Agency react," the agency said in a
statement late on Sunday.

One of the three health workers hospitalised in Norway after
receiving the AstraZeneca shot had died, health authorities said
on Monday, but there was no evidence that the vaccine was the
cause.

AstraZeneca said earlier it had conducted a review
covering more than 17 million people vaccinated in the European
Union and the UK which had shown no evidence of an increased
risk of blood clots.

Investigations into potential side-effects are complicated
as the history of each case and circumstances surrounding a
death or illness are examined. Austrian authorities have said
their review of the AstraZeneca batch will take about two weeks.

Long-awaited results from AstraZeneca 30,000-person U.S.
vaccine trial are currently being reviewed by independent
monitors to determine whether the shot is safe and effective, a
top U.S. official said on Monday.

(Reporting by Panarat Thepgumpanat in BANKOK and Andreas Rinke
and Paul Carrel in BERLIN, Angelo Amante in ROME, Christian Lowe
in PARIS, Toby Sterling in AMSTERDAM, Jacob Gronholt-Pedersen in
COPENHAGEN, Kate kELLAND in LONDON and Stanley Widianto in
JAKARTA; writing by Philippa Fletcher; editing by Nick Macfie)

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