U.S. health regulators recommended last week that use of the J&J
vaccine be paused after six cases of rare brain blood clots,
accompanied by low platelet levels, were reported in women following
vaccination, out of some 7 million people who have received the shot
in the United States. A panel of expert advisors to U.S. health
agencies will meet later this week to determine whether the pause
should continue, with a decision expected as early as Friday.
"My estimate is that we will continue to use it in some form," Dr.
Anthony Fauci, chief medical advisor to President Joe Biden, said
Sunday on NBC's "Meet the Press." “I do think that there will likely
be some sort of warning or restriction or risk assessment."
Scientists have yet to establish a direct link between the J&J
vaccine and the unusual blood clots, which have also been identified
among a tiny fraction of people who received AstraZeneca Plc's
COVID-19 vaccine outside of the United States. It is not clear how
long it would take to determine whether the vaccines cause such
symptoms.
In the meantime, however, scientists say that both vaccines remain
important tools to help combat a coronavirus pandemic that has
killed more than 3 million people globally. The key will be
communicating to doctors and patients how to look out for a
“one-in-a-million” side effect.
"It made sense to pause it," said Dr. Rishi Mehta, associate medical
director of inpatient operations at Keck Hospital at the University
of Southern California in Los Angeles, referring to use of the J&J
vaccine. "We should say: ‘Listen the side effects are rare, but
there is a potential for you to get them and these are what you
should look out for... We are talking about headaches, abdominal
pain, confusion."
The American Heart Association on Friday said other potential
symptoms, which could occur up to two weeks after vaccination, are
blurry vision, fainting, sensory changes, seizures, leg pain or
shortness of breath.
Doctors will also need to be vigilant when it comes to treatment.
Cases identified so far are of cerebral venous sinus thrombosis (CVST),
or blood clots in the brain's veins, rather than in the arteries,
which is the case for most strokes.
The U.S. Food and Drug Administration has said patients who exhibit
clot-related symptoms after receiving the J&J vaccine should not be
given heparin, a blood thinner that is widely used to treat clotting
disorders, at least until additional testing to determine whether
they have low platelet counts. The rare combination of clotting and
low platelets signals a condition called heparin-associated
thrombocytopenia, and giving heparin can cause harm.
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The FDA warned healthcare
providers that use of heparin in these cases
could even be fatal and advised them to strongly
consider non-heparin anticoagulants and
high-dose intravenous immune globulin (IVIG)
instead. "You would need to do a
few tests with anyone who has symptoms like this, and based on those
tests, you would be reasonably positioned to treat without putting
the person at risk,” Dr. Jeffrey Berger, a cardiologist focused on
blood clotting disease at New York University.
According to details published in the New England Journal of
Medicine on Friday, a 48-year-old woman who had the J&J shot was
transferred to the University of Nebraska Medical Center after being
diagnosed with extensive blood clotting, or thrombosis. She was
treated with heparin, but her condition worsened and she was
switched to a different anticoagulant and IVIG. The patient remained
critically ill at the time of the report. "If they
give heparin they can make matters worse, so that's a good reason to
call the attention to this," Fauci, director of the National
Institute for Allergy and Infectious Diseases, told Reuters.
Doctors said the pause in J&J vaccinations allows time for hospital
systems to update their own recommendations.
"It's certainly a very serious condition, but there are
recommendations for treatment," said Dr. Annabelle de St. Maurice,
infectious disease specialist, University of California at Los
Angeles. "Prior to this, someone who had the vaccine and had a
headache, our first idea wouldn't be to consider CVST and order the
labs and imaging to assess that."
Officials at J&J and AstraZeneca did not immediately respond to
requests for comment.
(Reporting by Deena Beasley in Los Angeles; Additional reporting by
Julie Steenhuysen in Chicago; Editing by Michele Gershberg and Lisa
Shumaker)
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