Denmark, Norway, Iceland Suspend AstraZeneca COVID Shots After Blood Clot Reports

[IceWizard]

Staff member handles AstraZeneca COVID-19 vaccines in storage
at Region Hovedstaden's Vaccine Center, Copenhagen, Denmark, on
Feb. 11, 2021.
(Ritzau Scanpix/Liselotte Sabroe via Reuters)







Denmark, Norway, Iceland Suspend AstraZeneca
COVID Shots After Blood Clot Reports


BY REUTERS
March 11, 2021
Updated: March 11, 2021



(COPENHAGEN)
—
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 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.