Europe Investigates Reports of Blood Clots in Recipients of J&J's Covid-19 Vaccine
09 April 2021 - 8:56PM
Dow Jones News
By Eric Sylvers and Jenny Strasburg
The European Union's health agency is investigating a small
number of reports of very rare cases of severe blood clots among
people who have received the Johnson & Johnson Covid-19
vaccine.
There have been four reported cases of serious blood clots,
including one death, in people who received the J&J vaccine,
the European Medicines Agency said on Friday. One case occurred in
a clinical trial and three were in people given the shot as part of
the U.S. vaccination campaign.
The EMA said it isn't clear yet whether there is a connection
between the vaccine and the blood clots and that the agency could
decide to mandate an update to the safety information included with
the vaccine. Last month, the EMA approved the J&J vaccine for
use in the EU, but the rollout isn't expected to begin until later
this month.
The scrutiny follows weeks of investigation into whether the
Covid-19 vaccine co-developed by AstraZeneca PLC is linked to rare
blood-clotting disorders.
The J&J review could further delay Europe's already
sputtering vaccine campaign and add fodder to the antivaccination
movement, which is particularly strong in some EU countries,
including France. Europe has vaccinated far fewer people than the
U.S., and many countries are banking on the single-jab J&J
vaccine to help the continent catch up.
About five million people have received the J&J vaccine in
the U.S., according to the Centers for Disease Control and
Prevention. The U.S. rollout of the vaccine, which is branded as
Janssen, a J&J unit, has been speeding up, though a sharp
slowdown in deliveries is expected next week. The J&J vaccine,
in addition to being administered in a single dose, has the
advantage over those developed by Pfizer Inc. and Moderna Inc. of
not needing to be stored at super-cold temperatures.
In a large trial of the vaccine, there were slightly more blood
clots among vaccine recipients than among those who received a
placebo. The U.S. 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.
"Our close tracking of side effects has revealed a small number
of very rare events following vaccination," J&J said. "At
present, no clear causal relationship has been established between
these rare events and the Janssen Covid-19 vaccine."
The company's vaccine, like the one developed by AstraZeneca, is
made by engineering a harmless type of virus -- such as an
adenovirus that can cause the common cold -- to carry a gene from
the coronavirus into the cell.
The AstraZeneca vaccine, which hasn't yet been approved for use
in the U.S., has run into a thicket of problems in Europe. It is
facing scrutiny about potential side effects, even though tens of
millions of doses have already been administered across Europe and
around the world.
U.K. and European medicines watchdogs this week said there is
strong evidence of a link between the vaccine and very rare but
serious blood-clotting events but said that for most people, the
benefits of the vaccine still far outweigh the small risk of
serious side effects
Italy, Spain, Germany, Australia and many other countries have
prohibited its use in younger people who have been shown to be more
likely to have issues with blood clotting. The U.K. advised that
people under 30 receive a different vaccine, citing the potential
relative risks of the AstraZeneca vaccine in younger people less
susceptible to the most serious effects of Covid.
This week, the University of Oxford, which co-developed the
AstraZeneca vaccine, stopped giving the vaccine to children and
teenagers taking part in a small-scale U.K. study. The university
said that while no safety issues have arisen in the trial, it
suspended vaccinations over concerns about the rare clotting that
has shown up in adults.
The EMA has said on several occasions that the benefits of the
AstraZeneca vaccine outweigh the risks, despite the agency finding
a possible link between the vaccine and the rare instances of blood
clots. Younger women have been more likely to experience
blood-clotting events, though the EMA has said it hasn't
established that gender or age are confirmed risk factors.
On Friday, the EMA also said it is investigating five reports of
a condition called capillary leak syndrome among millions of people
who have received the AstraZeneca vaccine. The rare disorder
involves blood leakage from blood vessels into surrounding tissue,
causing swelling and potential organ failure, according to health
experts.
From the very small number of instances reported, it isn't known
whether there is any connection to the vaccine, the EMA said.
"The EMA's review of a safety signal is routine practice and
essential to ensuring that regulators have the most up-to-date
information on benefits and risks. Currently there is no evidence
of a causal relationship with the vaccine. We are supporting the
ongoing review," AstraZeneca said in a statement.
Write to Eric Sylvers at eric.sylvers@wsj.com and Jenny
Strasburg at jenny.strasburg@wsj.com
(END) Dow Jones Newswires
April 09, 2021 14:41 ET (18:41 GMT)
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