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 The U.S. Centers for Disease Control and Prevention (CDC) advisory
panel decided to delay a vote on how best to use the J&J shot even
after a U.S. Food and Drug Administration scientist told advisers he
believed warnings could mitigate the risk of extremely rare but
serious blood clots.
The panel is reviewing six reported cases of rare brain blood clots
in women who received the J&J vaccine, a day after the FDA and CDC
jointly recommended pausing its use to assess the issue.
Dr. Lynn Batha, an epidemiologist at the Minnesota health
department, and several others spoke in favor of extending the pause
to gather more safety information.
"By having more robust information, I think we can be more confident
about how we talk about the safety of this vaccine," she told other
members of the advisory panel.
Earlier, the FDA's deputy director for vaccine development, Doran
Fink, told the panel that his current thinking was that warning
statements and communications from the federal agency would allow
doctors to weigh risks and benefits of the vaccine.
Other panel members and advisers, however, expressed concern that
extending the pause could worsen issues related to equitable access
to the vaccine, which is seen as important for serving hard-to-reach
communities because it can be stored at normal refrigerator
temperatures and given as one dose instead of two.
"Any extension of the pause will invariably result in the fact that
the most vulnerable individuals in the United States will remain
vulnerable," Nirav Shah, director of the Maine Center for Disease
Control and Prevention and a representative of the Association of
State and Territorial Health Officials told the panel. Shah is not a
voting member.
Several panel members wanted to vote to extend the pause by as much
as a month, but Dr. Beth Bell, a global health expert at the
University of Washington, argued that would send a signal globally
of a major issue with the vaccine.
"I don't want to send the message that there is something
fundamentally wrong with this vaccine, which I don't agree with,"
she said.
"It's a very rare event," Bell said of the cases of blood clots in
the brain, known as cerebral venous sinus thrombosis (CVST), along
with low blood platelets. "Nothing is risk-free."
The six cases, all in women under age 50, were reported out of 7.2
million doses of the J&J vaccine administered in the United States -
a risk federal health officials and immunology experts said was
extremely low, especially when weighed against the potential ravages
of COVID-19.
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 One of the six women died and
three remain hospitalized. So far, more than
562,000 people in the United States have died
from COVID-19.
Bell argued in favor of postponing a vote and
gathering more information, which the panel
decided to do. The FDA is
charged with weighing evidence on a vaccine's safety and
effectiveness, and could add warnings to existing labeling. The
panel's role is to advise public health officials and the CDC
director on how best to use vaccines once they are approved.
The FDA in an email to Reuters said it is continuing to review the
vaccine safety data, in partnership with the CDC, and will provide
updates on additional scientific evidence as they become available.
"It’s important that these deliberative processes that protect
patients are followed so that the American public has confidence in
vaccine safety and effectiveness," the FDA added.
The panel could recommend limiting the use of the vaccine to
specific age groups to reduce risks, and is likely issue advice to
healthcare providers on how to recognize concerning symptoms and
treat those patients.
One of the standard treatments for blood clots, heparin, could lead
to serious complications or death with this rare clotting condition.
Johnson & Johnson has not seen CVST in recipients of its Ebola
vaccine or its vaccine against respiratory syncytial virus (RSV),
which use similar technology, nor in its trial of a two-dose regimen
of the COVID-19 vaccine, according to a company presentation to the
vaccine advisory panel.
The group of outside advisers will make a decision by Friday on when
it will reconvene, which could be within a week to 10 days, CDC
officials said.
(Reporting by Susan Heavey, Mike Erman, Julie Steenhuysen, Manas
Mishra and Dania Nadeem; Editing by Peter Henderson, Bill Berkrot
and Grant McCool)
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