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(Adds details from Iceland, further comments, background)
COPENHAGEN, March 11 (Reuters) - Health authorities in
Denmark, Norway and Iceland on Thursday suspended the use of
AstraZeneca's COVID-19 vaccine shots following reports
of the formation of blood clots in some people who had been
vaccinated.
Austria earlier stopped using a batch of AstraZeneca shots
while investigating a death from coagulation disorders and an
illness from a pulmonary embolism.
Still, the European medicine regulator EMA https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazeneca-prac-investigating-cases-thromboembolic-events-vaccines-benefits
said the vaccine's benefits outweighed its risks and could
continue to be administered.
Europe is struggling to speed up a vaccine rollout after
delivery delays from Pfizer and AstraZeneca, even as a
spike in cases amid a more contagious virus variant has
triggered fresh lockdowns in countries like Italy and France.
Denmark suspended the shots for two weeks after a
60-year-old woman, who was given an AstraZeneca shot from the
same batch used in Austria, formed a blood clot and died, Danish
health authorities said.
Their response was also prompted by reports "of possible
serious side effects" from 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.
Iceland on Thursday suspended jabs with the vaccine as it
awaited the results of an investigation by the EMA. Italy, also
on Thursday, said it would suspend use of an AstraZeneca batch
different to the one 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.
"The problem with spontaneous reports of suspected adverse
reactions to a vaccine are the enormous difficulty of
distinguishing a causal effect from a coincidence," Stephen
Evans, professor of pharmacoepidemiology at the London School of
Hygiene & Tropical Medicine, told Reuters.
Evans added that the COVID-19 disease was very strongly
associated with blood clotting.
Phil Bryan, head of the UK Medicines and Healthcare Products
Regulatory Agency (MHRA) said reports of blood clots so far
didn't exceed what would have occurred naturally in the
vaccinated population.
"Available evidence does not confirm that the vaccine is the
cause," he said.
More than 11 million doses of AstraZeneca's vaccine have so
far been administered across the UK.
AstraZeneca told Reuters in a written statement the safety
of its vaccine had been extensively studied in human trials and
peer-reviewed data confirmed it was generally well tolerated.
The drugmaker said this week 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 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 was no higher than that seen in the general
population, with 22 cases reported among the 3 million people
who have received the shot as of March 9.
EMA said it understood the decision by Denmark and Norway
was taken as a precaution.
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 jab.
"There is nothing to indicate that the vaccine causes this
type of blood clots," Veronica Arthurson, head of drug safety at
the Swedish Medical Products Agency, told a news conference.
The Danish Medicines Agency said it had launched an
investigation into the vaccine together with corresponding
agencies in other EU countries and the EMA.
So far, 138,148 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 the final date for when it
expects all Danes to have been fully vaccinated would be pushed
back by four weeks to Aug. 15.
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.
The EU's drugs regulator on Thursday approved Johnson &
Johnson's single dose COVID-19 vaccine.
(Reporting by Nikolaj Skydsgaard and Jacob Gronholt-Pedersen in
Copenhagen, and Victoria Klesty in Oslo; Additional reporting by
Ludwig Burger in Frankfurt, Johan Ahlander in Stockholm,
Crispian Balmer in Rome and Kate Kelland in London. Editing by
Alex Richardson, Nick Macfie and Bernadette Baum)
