(Adds details, comments from Norwegian and Swedish health
officials)
By Nikolaj Skydsgaard and Jacob Gronholt-Pedersen
COPENHAGEN, March 11 (Reuters) - Health authorities in
Denmark and Norway said on Thursday they had temporarily
suspended the use of AstraZeneca's COVID-19 vaccine
shots after reports of the formation of blood clots in some who
have been vaccinated.
The move comes after Austria stopped using a batch of
AstraZeneca shots while investigating a death from coagulation
disorders and an illness from a pulmonary embolism.
Danish health authorities said the country's decision to
suspend the shots for two weeks came after a 60-year old woman
in Denmark, who was given an AstraZeneca shot from the same
batch that was used in Austria, formed a blood clot and died.
Danish authorities said they had responded "to reports of
possible serious side effects, both from Denmark and other
European countries."
"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 in Denmark.
"This is a cautionary decision," Geir Bukholm, director of
infection prevention and control at the Norwegian Institute of
Public Health (FHI), told a news conference.
FHI did not say how long the suspension would last.
"We ... await information to see if there is a link between
the vaccination and this case with a blood clot," Bukholm said.
Also on Thursday, Italy said it would suspend use of the
AstraZeneca batch that was used in Austria.
Some health experts said there was little evidence to
suggest the AstraZeneca 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,
adding that the COVID-19 disease was very strongly associated
with blood clotting.
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.
Swedish authorities said they did not find sufficient
evidence to stop vaccination with AstraZeneca's vaccine. Sweden
has found two cases of "thromboembolic events" in connection
with AstraZeneca's vaccine and about ten for the Pfizer-BioNTech
vaccine.
"We see no reason to revise our recommendation," Veronica
Arthurson, head of drug safety at the Swedish Medical Products
Agency, told a news conference. "There is nothing to indicate
that the vaccine causes this type of blood clots."
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, Victoria Klesty in Oslo and Kate Kelland
in London. Editing by Alex Richardson, Nick Macfie and
Bernadette Baum)