Germany, France, Italy Suspend Use of AstraZeneca's Covid-19 Vaccine -- Update
15 März 2021 - 7:25PM
Dow Jones News
By Bojan Pancevski and Jenny Strasburg
BERLIN -- Germany, France and Italy joined a group of smaller
European countries that have temporarily stopped administering
Covid-19 vaccines made by AstraZeneca PLC, saying the move was
precautionary amid a small number of cases of blood clotting
reported on the continent.
Denmark last week said it had paused AstraZeneca shots for two
weeks following reports of blood clotting, and several other
European countries quickly followed suit, saying they were doing so
out of an abundance of caution. Norway, Ireland and the Netherlands
are among countries that have paused vaccinating with AstraZeneca's
shot.
Health regulators in the U.K. and Europe, along with AstraZeneca
and its vaccine development partners at the University of Oxford,
say there is no known connection between severe clotting and the
shot. AstraZeneca has said the number of cases of blood clotting
among the roughly 17 million people in the European Union and U.K.
who have received the shot is lower than for the general
population.
Europe's medicines regulator said last week it was looking into
around 30 reported cases of severe clotting, out of around five
million people who have received the shot in the bloc. Last week,
the regulator, the European Medicines Agency, said the "vaccine's
benefits currently still outweigh risks" and has continued
recommending its use. The agency said most side effects are mild or
moderate. Clinical trials didn't raise flags about blood clotting
as a risk.
The temporary halt to the AstraZeneca shots is another major
setback in a wider vaccine rollout in Europe hamstrung by supply
shortages and other hurdles at the same time as the continent
wrestles with rising Covid-19 cases. Europe's vaccination rates are
far lower than in the U.S. and the U.K., where Covid-19 cases have
stabilized or are falling.
Delays in giving out the AstraZeneca vaccine threaten to
exacerbate vaccination-drive woes and could put further pressure on
governments trying to speed things up. AstraZeneca has become a
particular target of European politicians who have accused it of
not doing enough to provide the continent with more shots.
French President Emmanuel Macron, in announcing his country's
pause, said the EMA was expected to publish a recommendation
regarding the vaccine on Tuesday. The agency didn't immediately
respond to a request for comment.
The series of pauses across Europe threatens to undermine the
AstraZeneca vaccine's credibility just three months into its
rollout. The U.K. was the first country to adopt the shot for mass
use, at the end of December.
The shot previously faced skepticism over clinical-trial results
that suggested it wasn't as effective as other vaccines hitting the
market. Some of those perceptions have faded as the U.K. inoculated
millions of people with the shot, generating real-world data that
showed it to be strongly effective in preventing severe disease and
death.
The U.K.'s relatively quick vaccination program -- with some 11
million AstraZeneca shots playing a key role -- hasn't raised
blood-clotting concerns. The British medicines regulator has said
it maintains its confidence in the vaccine and its safety.
Last week, reports surfaced of a potential clotting issue, with
one death and a case of severe illness, in Austria. That country
suspended one batch of the vaccine but said it didn't have evidence
of a connection between the health incidents and the shot and kept
using it otherwise.
On Thursday, Denmark, Norway and Iceland halted use of the
vaccine altogether. Danish authorities said they would wait at
least two weeks before administering it again. The EMA, which acts
much like the Food and Drug Administration in regulating medicine
across the European Union, has already said serious blood clots
weren't any more common among vaccinated people than among the
general population. It has said it is investigating the reported
cases of multiple thrombosis, or the formation of blood clots
within blood vessels, and similar conditions.
Last week, AstraZeneca warned it would fall short of projected
vaccine deliveries to Europe in coming months, by 100 million doses
-- almost two-thirds less than what the continent was expecting
based on the company's earlier pledges.
AstraZeneca Chief Executive Pascal Soriot has repeatedly pushed
back against doubts about the shot's effectiveness and criticism of
its rollout. Last month, AstraZeneca said it would roughly double
global vaccine production to 200 million doses a month by
April.
In Germany, the Paul Ehrlich Institute, which regulates vaccine
use, said it became concerned by an unspecified number of new cases
showing thrombosis, blood-platelet deficiency and bleeding in
people soon after vaccination with the AstraZeneca shot. In a
statement on its website Monday, the institute said it recommended
temporarily halting use of the vaccine until further study by the
EMA after seeing what it called a "striking accumulation" of those
symptoms.
The regulator recommended that people who "feel increasingly
unwell" more than four days after receiving a vaccination should
seek medical attention. It flagged severe, persistent headaches or
"pinpoint bleeding" of the skin as symptoms of concern.
On Friday, a nonprofit global organization of specialists in
blood-clotting disorders and research, the Chapel Hill, N.C.-based
International Society on Thrombosis and Haemostasis, advised
continued use of the AstraZeneca vaccine. The society said that
based on available data, the benefits of vaccination outweigh the
risks "even for patients with a history of blood clots or for those
taking blood-thinning medications."
Covid-19 itself is known to cause blood clots, a factor
researchers say they are taking into account when considering the
benefits versus potential risks of vaccination.
Write to Bojan Pancevski at bojan.pancevski@wsj.com and Jenny
Strasburg at jenny.strasburg@wsj.com
(END) Dow Jones Newswires
March 15, 2021 14:10 ET (18:10 GMT)
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