U.S. Seeks to Pause J&J Covid-19 Vaccine Use After Rare Blood-Clot Cases -- 3rd Update
13 April 2021 - 10:47PM
Dow Jones News
By Peter Loftus
U.S. health authorities recommended a pause in the use of
Johnson & Johnson's Covid-19 vaccine in order to investigate
rare but severe cases of blood clots.
The U.S. Food and Drug Administration and the U.S. Centers for
Disease Control and Prevention announced the move Tuesday, after
finding that six women between the ages of 18 and 48 years who got
the vaccine had developed blood clots.
A panel of outside experts will meet Wednesday to review the
matter for the CDC, while the FDA will also conduct an
investigation.
The FDA said it was recommending a pause in the use of the
J&J vaccine "out of an abundance of caution."
The halt comes at a dangerous time during the pandemic, as
health authorities race to vaccinate as many people as possible
before variants develop that can evade the shots. Among the biggest
hurdles is overcoming hesitancy to get vaccinated.
The specter of blood clots could add to concerns about the
safety of the shots, though vaccines from Pfizer Inc. and its
partner BioNTech SE and from Moderna Inc. have proven relatively
safe so far.
J&J's vaccine was the third authorized for use in the U.S.
It uses similar technology as a vaccine from AstraZeneca PLC and
the University of Oxford, not yet authorized in the U.S. that has
also been linked to rare cases of blood clots.
In the case of J&J's shot, six women ages 18 to 48 developed
blood clots after taking the J&J vaccine, the FDA and CDC said.
The clots developed 6 to 13 days after vaccination. The women also
had in their blood low counts of platelets, which help with
clotting.
Given the nature of the side effect, doctors shouldn't use the
normal course of clotting treatment, involving a drug called
heparin, the FDA and CDC said. "In this setting, administration of
heparin may be dangerous, and alternative treatments need to be
given," they said.
The agencies said people vaccinated with J&J's vaccine
should notify their doctor if they develop severe headache,
abdominal pain, leg pain, or shortness of breath within three weeks
after vaccination.
Clots can be life-threatening, even fatal, if they choke off
blood and therefore oxygen flow to the brain or heart. The type of
blood clot seen in some people receiving the J&J vaccine was
called a cerebral venous sinus thrombosis, which can prevent blood
from draining out of the brain and can lead to a hemorrhage.
Like other Covid-19 vaccine makers, J&J, of New Brunswick,
N.J., developed its shot much more quickly than it usually takes to
develop a vaccine, given the urgency of the pandemic. The company
began work in early 2020 and started testing the vaccine in people
in July.
Certain types of blood clots were seen in a small number of
subjects in the large clinical trial of J&J's vaccine that
supported its authorization in late February. The FDA said there
wasn't enough evidence at the time to determine whether the vaccine
was causing the clots, but said it would monitor the situation.
J&J also has had problems manufacturing its vaccine. A batch
of the vaccine's main ingredient that was being made at a
contractor's plant in Baltimore was recently ruined by
contamination, and no doses were distributed from the batch. Health
regulators still haven't authorized the plant where the mishap
occurred, hurting J&J's ability to churn out more doses.
Earlier this month, U.K. health authorities recommended against
giving AstraZeneca's shot to people under 30 years after receiving
reports of rare but deadly blood clots. Countries including Canada
and Germany have also restricted use.
The link between the vaccine and the clotting incidents is still
unclear. Scientists in Germany and Norway said the vaccine may
cause an autoimmune reaction that leads to clots in the brain.
Write to Peter Loftus at peter.loftus@wsj.com
(END) Dow Jones Newswires
April 13, 2021 08:32 ET (12:32 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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