(Adds details, comment by AstraZeneca, Danish health minister,
Spain)
COPENHAGEN, March 11 (Reuters) - Denmark has put using
AstraZeneca's COVID-19 vaccine shots on hold for two
weeks after reports of cases of blood clots forming, including
one death in Denmark, Danish authorities said on Thursday.
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.
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)