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WRAPUP 3-Europe aims to get vaccinations back on track after clearing AstraZeneca shot

Fri, 19th Mar 2021 17:21

(Adding WHO, Finland's stance, vaccination queues in Italy)

* EU regulator: AstraZeneca shot's benefits outweigh risks

* UK agency says vaccines should continue while checks made

* WHO backs Anglo-Swedish vaccine after review

By Anthony Deutsch, Toby Sterling and Alistair Smout

AMSTERDAM/LONDON, March 19 (Reuters) - Europe pushed to get
its COVID-19 vaccination drive back on track on Friday after EU
and British regulators said the benefits of AstraZeneca's
shot outweighed any risks and the World Health
Organization gave its backing to it.

The end to the suspension of AstraZeneca shots by more than
a dozen countries will now kick off a test of public confidence,
both in the vaccine and regulators who are under unprecedented
scrutiny as variants of the coronavirus spread and the global
death toll climbs beyond 2.8 million.

At least 13 European countries stopped administering the
shot after reports of a small number of blood disorders. More
than 55 million people have received a vaccine from all
manufacturers in the EU and the European Economic Area (EEA),
which links 30 European countries.

The hold-up with AstraZeneca slowed an already faltering
inoculation campaign across the 27-nation European Union, which
is lagging ex-member state Britain and the United States.

Europe's leaders say they need to accelerate their
vaccination drive, with deaths in the EU topping 550,000, less
than a 10th of the bloc's population inoculated and growing
signs of an imminent third wave of infections.

Germany, Italy and others countries including Indonesia
began on Friday to administer the shots they had suspended after
the EU drug regulator's investigation, which covered about 30
cases of rare brain blood clots out of 20 million people who
received the AstraZeneca shot in the UK and EU.

France's health regulator, however, recommended that only
over 55s should get AstraZeneca shots due to concern that those
younger were more at risk of clots, while Lithuania will let
people choose their vaccine in a possible litmus test of
sentiment.

The European Medicines Agency (EMA) came to what it called a
clear conclusion that the vaccine's benefits in protecting
people from coronavirus-related death or hospitalisation
outweighed the possible risks.

Still, EMA said a link between rare events of blood clots in
the brain and the shot could not be definitively ruled out and
it would continue its scrutiny, as will the British Medicines
and Healthcare products Regulatory Agency (MHRA).

"This is a safe and effective vaccine," EMA Director Emer
Cooke told a briefing on Thursday. "If it were me, I would be
vaccinated tomorrow."

On Friday, Finland suspended the use of the vaccine while it
investigates two possible cases of blood clots. It estimated
that the investigation would take at least one week.

PRUDENT REINTRODUCTION

The WHO became the latest public health body to endorse the
shot, saying on Friday that available data do not point to any
overall increase in clotting conditions. It said it would
continue to monitor for any adverse effects.

That came after its vaccine advisory committee's review.

The EMA said on Thursday it would update its guidance on the
vaccine to include an explanation for patients about potential
risks and information for healthcare professionals to help
people recognise when they may need medical assistance.

Germany resumed administering the vaccine on Friday morning
after a three-day pause as the nation's health minister warned
there were not enough vaccines in Europe to contain a third wave
of coronavirus infections.

"We can reintroduce AstraZeneca but prudently, with informed
doctors and appropriately educated citizens," Health Minister
Jens Spahn said.

In Italy, where Prime Minister Mario Draghi said the country
was also resuming vaccinations with AstraZeneca's shot, about
200,000 inoculations had been put on hold, leaving regions in
control of inoculations to reschedule them.

"They already have the doses, it's not like we have to
distribute more today," an Italian health ministry spokesman
said.

Red Cross organisers at Rome's Termini vaccination centre
said there was a queue of people waiting well ahead of their
booked appointments when the centre reopened in the afternoon.

"The situation here is very brisk...This tells us that
people want to get vaccinated and they still have faith in this
good AstraZeneca vaccine," said Red Cross health service
coordinator Valerio Mogini.

"I did have a few doubts but as soon as the validation of
the vaccine was confirmed we decided to do it, we trust them and
we are calm", Federica, 24, a teacher, said while awaiting her
shot at a drive-in vaccination stop in Milan.

Spain will resume inoculations from Wednesday with the
Netherlands also planning to start using AstraZeneca shots again
next week.

Canada also gave its support to the vaccine though Denmark
and Sweden both said they needed more time to make a decision.

French Prime Minister Jean Castex said he would get the shot
on Friday to try to promote public acceptance. Still, the
country's recommendation for giving the shot only to those 55
and older reflects a lingering reluctance.

"The EMA has identified a possible increased risk of
(thrombosis) in people under 55 years old," France's drug
regulator said.

The central African country of Cameroon, meanwhile,
suspended the AstraZeneca vaccine on Friday, saying it was a
precautionary move, without providing specifics.

'INCREDIBLY REASSURING'

Amid a mixed global picture, some experts sought to
reinforce confidence in AstraZeneca's vaccine, which is seen as
an important asset globally due to its relatively easy storage
and transport requirements and its low price compared to mRNA
vaccines made by Pfizer and Moderna.

"What we really should be focusing on is that this is
incredibly reassuring. The processes are working, the safety
monitoring that we all expect from our authorities is
happening," Andrew Pollard, who runs the Oxford Vaccine Group,
told BBC radio.

"We do need to continue to monitor safety, but in the end
it's the virus we're fighting, not the vaccines."

Oxford University partnered with AstraZeneca to develop the
vaccine.

Britain's MHRA is investigating five cases of the rare brain
blood clot among 11 million shots administered in the country.

The MHRA, like the EMA, said it would scrutinise reports of
clots in the cerebral veins - know as sinus vein thrombosis, or
CSVT - occurring together with lowered platelets soon after
vaccination.

But the agency said the vaccine should continue to be used
and one official said Britain's roll-out would probably carry on
even if a link were proven.

The drugmaker's own review covering more than 17 million
people who have received its shot in the EU and Britain found no
evidence of increased risk of blood clots.

(Reporting by Anthony Deutsch and Toby Sterling in Amsterdam,
Ludwig Burger in Frankfurt, Kate Kelland and Alistair Smout in
London, John Miller in Zurich and Caroline Copley in Berlin,
Eleanor Biles in Rome and Alex Fraser in Milan; Writing by John
Miller and Josephine Mason; Editing by Nick Macfie and Mark
Heinrich)

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