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 They did not say how many reports of blood clots there had been, but
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.
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
also 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.
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EMA was not immediately available for comment on Thursday.
Four other countries - Estonia, Lithuania, Luxembourg and Latvia -
have stopped inoculations from the batch while an investigation
continues, the EMA said.
The batch of 1 million doses went to 17 EU countries.
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 also uses
vaccines from Pfizer-BioNTech and Moderna
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.
(Reporting by Jacob Gronholt-Pedersen and Nikolaj Skydsgaard in
Copenhagen; additional reporting by Ludwig Burger in Frankfurt.
Editing by Alex Richardson and Nick Macfie)
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