By Betsy McKay
A federal advisory panel will meet Wednesday to debate whether
and how Johnson & Johnson's Covid-19 vaccine should continue to
be used in the U.S., following reports of rare but severe blood
clots among a few recipients.
The Advisory Committee on Immunization Practices, or ACIP, is
expected to review clinical data gathered to date on six women
between the ages of 18 and 48 years who developed blood clots after
receiving J&J's vaccine, according to a draft agenda of the
meeting posted online Tuesday.
The committee's virtual emergency meeting, scheduled for three
hours Wednesday afternoon, will be open to the public.
Its findings and decisions will help determine how the federal
government moves forward with the J&J vaccine at a difficult
juncture in the pandemic. The U.S. is racing to vaccinate more
people to damp the impact of more-infectious and rapidly spreading
variants of the Covid-19 virus.
J&J has said it is aware of the cases involving blood clots
and low platelet counts and is working with health authorities. It
is unclear whether the vaccine is the cause. President Biden said
the U.S. has sufficient supplies of other vaccines to inoculate all
eligible adults in the U.S.
The ACIP advises the U.S. Centers for Disease Control and
Prevention on who should get vaccines and how they should be
The recommendations made by its 14 voting members--medical and
public-health experts from outside the agency--go to the CDC
director, who decides whether to make them policy. The U.S. Food
and Drug Administration will also review the committee's
recommendations on the J&J vaccine.
The ACIP recommended who should be given priority for Covid-19
vaccines and in which order. After the FDA authorized Covid-19
vaccines from Pfizer Inc. and partner BioNTech SE, Moderna Inc. and
then Johnson & Johnson, the panel recommended the shots.
Only a few details about the six blood-clot cases are known
publicly. The patients developed symptoms including headaches,
abdominal pain, nausea and neurological symptoms six to 13 days
after vaccination. All six were diagnosed with blood clots in
vessels draining blood from the brain; two also had clots in
vessels that drain the intestines.
One of the women died and another is in critical condition,
according to federal health officials.
One of the six, a woman in her late 40s from Douglas County,
Neb., developed blood clots two weeks after receiving her vaccine.
Nebraska public health officials announced an investigation into
that case on April 9.
More than 6.8 million J&J doses have been administered to
date in the U.S. The six women's cases were reported to the federal
government's vaccine adverse-event reporting system in late March
and early April.
The CDC issued an alert to healthcare providers Tuesday warning
them to screen patients for the blood-clotting condition if they
recently received the J&J vaccine and have severe headache or
abdominal pain, shortness of breath, backache, leg swelling, new
neurological symptoms or new or easy bruising. The condition
requires a unique treatment, different from the standard protocol
involving the anticoagulant heparin, the agency also warned.
The ACIP's task will be to try to establish whether the vaccine
caused the blood clots, and then how it should be used going
forward, said Walter Orenstein, associate director of the Emory
Vaccine Center at Emory University and a former head of the CDC's
U.S. Immunization Program.
That will mean weighing the benefits of protecting people
against a deadly disease, particularly with new surges in the
pandemic under way, against the risks posed by the vaccine, Dr.
"That will be a fundamental issue," he said. "Even if they're
not sure if it's causal, do the benefits outweigh the risks?"
The committee could recommend continuing vaccination with the
J&J product "at full throttle," he said. It could decide that
the J&J vaccine be discontinued for certain groups--such as
younger adult women--or halt its use altogether, given that two
other vaccines are available, he said.
It is possible more data will become available before the
meeting to help the ACIP panel make a recommendation, if more cases
come to light, Dr. Orenstein said. "All of the publicity may get
people to report who hadn't previously reported," he said.
Jason Schwartz, assistant professor of health policy and the
history of medicine at the Yale School of Public Health, said he
expects the ACIP panel to offer more medical guidance to healthcare
providers about the risk of blood clots and how to treat them
rather than make big changes.
"I'm not sure the committee would want to take broad steps," he
said, given the small number of cases.
Additional guidance would be important, he said, because the
condition the six women experienced--blood clots and low blood
platelet counts--requires treatment that is different from what
some doctors might typically provide.
Vaccination and infectious disease experts praised the
government's quick recommendation to pause the use of J&J's
vaccine and then hold an open meeting to evaluate the data.
"It shows that our regulatory agencies are working properly,"
said Krutika Kuppalli, assistant professor of infectious diseases
at the Medical University of South Carolina. "They picked up a
signal and they jumped on top of it. They want to be careful; they
want to be transparent."
Write to Betsy McKay at firstname.lastname@example.org
(END) Dow Jones Newswires
April 14, 2021 05:44 ET (09:44 GMT)
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