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(Adds comments from Sweden, UK professor)
By Nikolaj Skydsgaard and Jacob Gronholt-Pedersen
COPENHAGEN, March 11 (Reuters) - Denmark is suspending for
two weeks the use of AstraZeneca's COVID-19 vaccine
shots after reports of the formation of blood clots in some who
have been vaccinated, including one death in Denmark, Danish
authorities said on Thursday.
The move comes after one person in Denmark who was given the
AstraZeneca shot formed a blood clot and died, the Danish Health
Authority said.
Austria has stopped using a batch of AstraZeneca shots while
investigating a death from coagulation disorders and an illness
from a pulmonary embolism.
"Both we and the Danish Medicines Agency have to respond to
reports of possible serious side effects, both from Denmark and
other European countries," the director of the Danish Health
Authority, Soren Brostrom, said in a statement.
"It is currently not possible to conclude whether there is a
link. We are acting early, it needs to be thoroughly
investigated," Health Minister Magnus Heunicke said on Twitter.
The vaccine would be suspended for 14 days. The health
agency did not give details of the Danish blood clot victim.
Some health experts said there was little evidence to
suggest the vaccine should not be administered and that the
cases of blood clots corresponded with the rate of such cases in
the general population.
"This is a super-cautious approach based on some isolated
reports in Europe," Stephen Evans, professor of
pharmacoepidemiology at the London School of Hygiene & Tropical
Medicine, told Reuters.
"The problem with spontaneous reports of suspected adverse
reactions to a vaccine are the enormous difficulty of
distinguishing a causal effect from a coincidence," he said.
AstraZeneca on Thursday told Reuters in a written statement
the safety of its vaccine had been extensively studied in human
trials and peer-reviewed data had confirmed the vaccine was
generally well tolerated.
The drugmaker said earlier this week its shots were subject
to strict and rigorous quality controls and that there had been
"no confirmed serious adverse events associated with the
vaccine". It said it was in contact with Austrian authorities
and would fully support their investigation.
The European Union's drug regulator, the European Medicines
Agency (EMA), said on Wednesday there was no evidence so far
linking AstraZeneca to the two cases in Austria.
It said the number of thromboembolic events - marked by the
formation of blood clots - in people who have received the
AstraZeneca vaccine is no higher than that seen in the general
population, with 22 cases of such events being reported among
the 3 million people who have received it as of March 9.
EMA was not immediately available for comment on Thursday.
Four other countries - Estonia, Lithuania, Luxembourg and
Latvia - have stopped inoculations from the batch while
investigations continue, the EMA said.
The batch of 1 million doses went to 17 EU countries.
"We do not think that there is sufficient evidence to stop
vaccination with AstraZeneca's vaccine," Veronica Arthurson,
head of drug safety at the Swedish Medical Products Agency, told
Newsagency TT.
The Danish Medicines Agency said it had launched an
investigation into the vaccine together with corresponding
agencies in other EU countries as well as the EMA.
"It is important to emphasise that we have not opted out of
using the AstraZeneca vaccine, but that we are putting it on
hold," Brostrom said.
So far, 136,090 Danes have received a shot with
AstraZeneca's vaccine in a country of 5.8 million. The Nordic
country, which also uses vaccines from Pfizer-BioNTech
and Moderna, is set to receive 2.6 million doses from
AstraZeneca over the coming months.
Denmark's Health Authority said it had pushed back the final
date for when it expects all Danes to have been fully vaccinated
by four weeks to Aug. 15 as a result of the vaccine suspension.
Spain On Thursday said it had not registered any cases of
blood clots related to AstraZeneca's vaccine so far and would
continue administering the shots.
(Additional reporting by Ludwig Burger in Frankfurt, Johan
Ahlander in Stockholm and Kate Kelland in London. Editing by
Alex Richardson, Nick Macfie and Bernadette Baum)
