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Pin to quick picksAstrazeneca Share News (AZN)

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Nearly a dozen countries resume AstraZeneca shots after EU, UK regulators say benefits outweigh risks

Fri, 19th Mar 2021 10:10

* EMA says benefits outweigh risks

* Can not definitively rule out link between clots and
vaccine

* UK agency says vaccines should continue while checks made

* WHO plans update on AZ vaccine after EMA guidance

By Anthony Deutsch, Toby Sterling and Alistair Smout

AMSTERDAM/LONDON, March 19 (Reuters) - Nearly a dozen
countries resumed use of AstraZeneca's COVID-19 shots on
Friday as EU and British regulators said the benefits outweighed
any risks after reports of rare instances of blood clotting that
temporarily halted inoculations.

The end of suspensions will kick off a test of public
confidence, both in the shot and in drug regulators whose
conclusions are under unprecedented scrutiny, as virus variants
spread and the global death toll, now at nearly 2.7 million,
rises.

Indonesia joined Germany, France and others in
re-administering the shots after they suspended vaccinations on
reports of around 30 cases of rare brain blood clots, after
millions of injections, that sent scientists and governments
scrambling to determine if there was a link.

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
that it will continue its scrutiny, along with 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."

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

After the EMA move, others also sought to reinforce
confidence in AstraZeneca's vaccine, which is seen globally as
an important asset due to its relatively easy storage and
transport requirements and inexpensive 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, after both regulators said vaccinations could
continue after reports of blood clots.

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

Oxford University is partnered with AstraZeneca on the
vaccine.

Germany resumed administering the AstraZeneca vaccine from
Friday morning, while French Prime Minister Jean Castex said he
would seek to promote a similar resumption in his country by
getting the shot himself on Friday.

Italian Prime Minister Mario Draghi said Italy would follow
suit, echoing sentiments from Cyprus, Latvia and Lithuania.

Spain will resume inoculations from Wednesday.
Canada also gave its backing to the vaccine.

Britain's MHRA is investigating five cases of the rare brain
blood clot that had been reported out of 11 million shots
administered in the UK.

It said it would investigate reports of clots in the
cerebral veins (sinus vein thrombosis, or CSVT) occurring
together with lowered platelets soon after vaccination. But the
agency said use of the vaccine should continue and one official
said Britain's rollout would likely not stop even if a link was
proved.

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.

The World Health Organization, which this week also
reaffirmed its support for the shot that remains a centrepiece
of its COVAX vaccine sharing programme, plans on Friday to give
an update on its vaccine advisory committee's own review.

(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;
Writing by John Miller; Editing by Nick Macfie)

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