By Jenny Strasburg and Bojan Pancevski
Germany, Italy, France and Spain joined the ranks of European
countries that have temporarily halted use of the Covid-19 shot
made by AstraZeneca PLC over blood-clot concerns, dealing another
blow to the continent's sluggish vaccination rollout and
threatening the credibility of the vaccine itself.
A cascade of cautionary pauses that started last week picked up
Monday. Denmark was the first to suspend the shots. Ireland,
Norway, the Netherlands and Iceland have also said they would wait
for Europe's bloc-wide medicines regulator to investigate a small
number of serious blood-clotting issues among people who had
received the AstraZeneca shot.
That regulator, the European Medicines Agency, is expected by
Thursday to give its verdict on safety and potential risks from a
review of the reported cases. The agency on Monday repeated an
advisory from last week that for now it is recommending countries
keep using the vaccine, saying the benefits outweigh possible
risks.
The EMA, which acts much like the U.S. Food and Drug
Administration in regulating medicine across the European Union,
has said there was no evidence of a link between the reported blood
clots and the vaccine.
The U.K.'s medicines regulator, the first to green-light the
shot for mass use in late December, maintained that stance as well,
telling Britons to get their shots as planned. Around 11 million
AstraZeneca shots have been administered in the U.K., making it a
central pillar of the country's fast-paced rollout.
The vaccine hasn't been approved in the U.S. AstraZeneca is
expected to apply for authorization for emergency use once it
submits results from Phase 3 human trials conducted in the U.S.
Those trials are due as early as this month.
The temporary halt to the AstraZeneca shots is another setback
in a wider vaccine rollout in Europe hamstrung by supply shortages
and other hurdles. It comes as the continent wrestles with rising
numbers of 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.
For U.K.-based AstraZeneca, the suspension of the shot across
the continent's wealthiest and most populous countries poses a new
threat to the vaccine's credibility, whether or not a link is shown
to exist, health policy experts said. Decisions to pull back from
vaccine schedules "are bound to fuel hesitancy" over the
AstraZeneca vaccine, said Stephen Griffin, associate medical
professor at the University of Leeds, and could cause more general
antivaccine views to spread. "My worry is for those anxious" even
before the halts, he said.
Karl Lauterbach, a professor of epidemiology and a legislator in
Germany's federal parliament, criticized his country's move. He
said an investigation without pausing shots would have made more
sense amid the upsurge in cases in Europe. "In the third wave,
which is now picking up speed, the first vaccinations with the
AstraZeneca vaccine would be lifesavers," he tweeted.
Swaths of the developing world are depending on the shot from
AstraZenenca, which has promised to deliver 3 billion doses this
year at cost. The temporary halts in Europe could raise concerns
among recipients elsewhere.
Reflecting that concern, the World Health Organization on Monday
recommended vaccinations go forward as normal to avoid unnecessary
deaths from Covid-19. The WHO is also probing the blood-clotting
reports but so far has found no evidence the conditions are linked
to the vaccine, a spokesman said.
AstraZeneca, which developed the vaccine in partnership with the
University of Oxford, has said the number of cases of blood
clotting among the roughly 17 million people in the EU and U.K. who
have received the shot is lower than for the general population.
Large-scale human trials also didn't raise flags about blood
clotting as a risk.
Germany's health minister, Jens Spahn, said Monday that pausing
the AstraZeneca rollout was a precautionary measure following
advice from Germany's vaccine regulator, the Paul Ehrlich
Institute. The institute advised the halt after seven cases of
blood clotting were reported following the administration of 1.6
million doses in the country.
The number of incidents in Germany and across Europe was small
and authorities were trying to establish whether they were related
to the vaccine, Mr. Spahn said. Germany is looking to the EMA for
advice, he said.
The series of pauses across Europe delivers a fresh jolt to
AstraZeneca's vaccine effort just three months into its rollout.
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.
There have also been manufacturing delays. 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.
The blood clots reported in some people who received the
AstraZeneca-Oxford vaccine are known generally as venous
thromboembolic events, and are relatively common.
They involve the formation of a thickened clump of blood in a
blood vessel, which can cause fatal blockages. Health officials in
the U.S. have included thromboembolic events among various types of
adverse events of special interest they are monitoring as Covid-19
vaccines get deployed widely.
In a large trial of Johnson & Johnson's Covid-19 vaccine,
which was authorized for use in the U.S. in late February, there
were slightly more blood clots among vaccine recipients than among
those who received a placebo. The Food and Drug Administration said
it couldn't exclude the possibility that the vaccine contributed to
the higher number, and plans to monitor for clots as the J&J
shot gets deployed in the larger population.
Venous thromboembolism also can occur in people with Covid-19.
The International Society on Thrombosis and Haemostasis, whose
members include medical professionals who treat blood clots, issued
a statement Friday recommending that all eligible adults continue
to get a Covid-19 vaccine because the small number of reported
thrombotic events relative to the millions of vaccinations doesn't
suggest a direct link.
--Peter Loftus contributed to this article.
Write to Jenny Strasburg at jenny.strasburg@wsj.com and Bojan
Pancevski at bojan.pancevski@wsj.com
(END) Dow Jones Newswires
March 15, 2021 16:51 ET (20:51 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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