By Deena Beasley
April 19 (Reuters) - Resuming the use of Johnson & Johnson's
COVID-19 vaccine in the United States will require clear
guidelines for the medical community on how to best treat
patients that develop a rare type of blood clot, as well as
alerting vaccine recipients to be aware of the telltale
symptoms, according to heart doctors and other medical experts.
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.
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)
Astrazeneca (AZN)
