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WRAPUP 7-Germany, Italy, France suspend AstraZeneca shots amid safety fears, disrupting EU vaccinations

Mon, 15th Mar 2021 10:46

(Adds planned EMA meeting, French, Italian quotes)

* Italian prosecutor seizes batch of vaccine after man dies

* Denmark, Netherlands give more details of clotting issue

* No proven link to COVID-19 vaccines -top WHO scientist

* 'We do not want people to panic,' she says

By Thomas Escritt and Stephanie Nebehay

BERLIN/GENEVA, March 15 (Reuters) - Germany, France and
Italy said on Monday they would suspend AstraZeneca COVID-19
shots after several countries reported possible serious
side-effects, but the World Health Organization
(WHO) said there was no proven link and people should not panic.

Still, the decision by the European Union's three biggest
countries to put inoculations with the AstraZeneca shot
on hold threw the already struggling vaccination campaign in the
27-nation EU 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.

Spain will stop using the vaccine for at least 15 days,
Cadena Ser radio reported, citing unnamed sources.

The top WHO scientist reiterated on Monday that there have
been no documented deaths linked to COVID-19 vaccines.

"We do not want people to panic," Soumya Swaminathan said on
a virtual media briefing, adding there has been no association,
so far, pinpointed between so-called "thromboembolic events"
reported in some countries and COVID-19 shots.

WHO chief Tedros Adhanom Ghebreyesus said an advisory
committee meeting on AstraZeneca would be held on Tuesday. EU
medicines regulator EMA will also convene this week to assess
the information gathered into whether the AstraZeneca shot
contributed to thromboembolic events in those inoculated.

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 EMA due on Tuesday.

"The decision taken, in conformity also with our European
policy, is to suspend, out of precaution, vaccination with the
AZ shot, hoping that we can resume quickly if the EMA’s guidance
allows,” French President Emmanuel Macron said.

Italy said its halt was a "precautionary and temporary
measure" pending EMA's ruling.

"The EMA will meet soon to clarify any doubts so that the
AstraZeneca vaccine can be resumed safely in the vaccination
campaign as soon as possible," said Gianni Rezza, Director
General of Prevention at Italy's Ministry of Health.

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 WHO appealed to countries not to suspend vaccinations
against a disease that has caused more than 2.7 million deaths
worldwide. WHO Director-General Tedros said systems were in
place to protect public health.

"This does not necessarily mean these events are linked to
COVID-19 vaccination, but it's routine practice to investigate
them, and it shows that the surveillance system works and that
effective controls are in place," he told the media briefing.

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.”

Italian medicine agency Aifa's general director, Nicola
Magrini, said several European countries preferred to suspend
the vaccine "in the presence of some very recent and very few
cases of adverse events" in women and young people.

"...Those who have already had the vaccine can and must
remain safe," she told a radio station. "I feel like saying the
vaccine is safe, even having reviewed all the data."

'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 stumbling 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
shot, hours after putting 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 the vaccine was the cause.

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

Long-awaited results from AstraZeneca's 30,000-person U.S.
vaccine trial are now 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, Emilio Parodi in MILAN,
Nathan Allen in MADRID, Emma Farge in GENEVA and Stanley
Widianto in JAKARTA; writing by Philippa Fletcher; editing by
Nick Macfie and Mark Heinrich)

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