By Betsy McKay and Peter Loftus
A federal advisory panel declined Wednesday to vote on how
Johnson & Johnson's Covid-19 vaccine should be used, saying it
needs more time to gather information on the risk of the shot
following reports of cases of rare but severe blood clots that
developed in a few recipients.
The Advisory Committee on Immunization Practices, or ACIP, said
it doesn't have enough information yet about the risk of these
unusual side effects to determine whether the vaccine should be
continued, discontinued or recommended only for certain groups of
The ACIP expects to meet again in another week or two to revisit
the issue. U.S. health officials on Tuesday recommended that use of
the J&J vaccine be paused while they investigate.
The ACIP, which advises the Centers for Disease Control and
Prevention on vaccination policy, met to review clinical data
gathered to date on six women between the ages of 18 and 48 years
old who developed clots in vessels draining blood from their brains
and in some cases other parts of the body after receiving J&J's
vaccine. More than 7.2 million doses of the J&J vaccine have
been administered in the U.S.; about 1.5 million of those doses
went to women between ages 18 and 50 years.
While Wednesday's discussion was limited to six cases, CDC
officials said they expect more will come to light, either cases
that have gone unrecognized or that may yet occur. About 52% of the
J&J doses to date were administered within the past two
The ACIP's 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.
Jeffrey Zients, the White House Covid-19 response coordinator,
said Wednesday that supplies of other vaccines are sufficient to
make up for scheduled J&J doses and to meet President Biden's
goal of reaching 200 million doses in his first 100 days in office.
He said 28 million doses of vaccines from Pfizer Inc. and Moderna
Inc. were shipped this week.
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 causes the side effects.
The six cases exceed the background rate for the rare brain
blood-clotting condition alone in women of this age group, said Tom
Shimabukuro, a vaccine safety expert at the CDC who presented data
on the cases. The illness the six women developed -- cerebral
venous sinus thrombosis, or CVST, combined with a low-platelet
count -- is even more rare, he said.
Based on the current data, J&J believes the overall
risk-benefit profile for its vaccine is positive across the
population for which it is authorized, Aran Maree, chief medical
officer of J&J's pharmaceuticals unit, said during the
Dr. Maree said J&J was still seeking more details about the
six cases since the vaccine was authorized for U.S. use in late
The CDC issued an alert to healthcare providers Tuesday warning
them to screen patients for the blood-clotting condition who
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, and healthcare providers shouldn't
give these patients the standard treatment, which involves using
the anticoagulant heparin, the agency also warned.
The recommendations made by the ACIP's 14 voting members --
medical and public health experts from outside the agency -- go to
the CDC director, who decides whether or not to make them policy.
The FDA will also review the committee's assessment of the
The ACIP recommended who should be prioritized for Covid-19
vaccines, and in which order. After the U.S. Food and Drug
Administration authorized Covid-19 vaccines from Pfizer and partner
BioNTech, Moderna Inc. and then J&J, the panel recommended the
No obvious risk factors stood out among the six women, the CDC's
Dr. Shimabukuro said. All of the patients are white. Whites have
received about 64% of the J&J vaccines administered, and men
and women ages 18 to 49 years have received 47% of the shots.
One of the women used estrogen or progesterone. None was
pregnant or had recently given birth. Three were defined as obese,
and one each had hypothyroidism, hypertension, and asthma. None was
known to have coagulation disorders, the CDC said.
The patients all initially developed vague symptoms six to 13
days after vaccination. Five had headaches, and one a backache and
bruising. Some also had abdominal pain, chills and nausea, and
neurological symptoms. All six were diagnosed with blood clots in
vessels draining blood from the brain; three also had clots in
vessels elsewhere in the body, such as in vessels that drain the
"We have clots forming in large vessels in the presence of low
platelets, " Dr. Shimabukuro said. "It's kind of a paradox
One 45 year-old woman died. Three others remain in the hospital,
two of whom are intensive care, the CDC said. The remaining two
have been discharged from the hospital.
One 48 year-old woman, treated in Omaha, Neb., developed blood
clots in vessels in her brain and abdominal cavity two weeks after
receiving her vaccine. She was initially treated with heparin, then
switched to other medications, and has yet to recover, according to
a presentation by Dr. Maree.
Vaccination and infectious disease experts praised the
government's quick recommendation to pause the use of J&J's
vaccination 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 email@example.com and Peter Loftus
(END) Dow Jones Newswires
April 14, 2021 18:27 ET (22:27 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.