By Peter Loftus and Betsy McKay
Johnson & Johnson's Covid-19 vaccine could be back in
circulation this weekend -- albeit with possible restrictions --
depending on a recommendation Friday by a federal advisory
J&J vaccine injections were put on hold last week after
reports of rare blood-clot conditions in a handful of recipients,
including one fatality.
Many public-health authorities, however, contend that the
benefits of the vaccine outweigh the risks. Anthony Fauci,
President Biden's chief medical adviser, has predicted the U.S.
pause would end as soon as Friday, perhaps with new restrictions or
The Advisory Committee on Immunization Practices, which includes
doctors and public-health officials, is expected to advise the Food
and Drug Administration and Centers for Disease Control and
Prevention to either continue or lift the pause after a meeting
A recommendation to lift the pause -- and agreement by the FDA
and CDC -- could put the vaccine back in circulation as early as
this weekend, because millions of doses have already been
distributed to vaccine sites.
The lifting of the pause could be accompanied by restrictions
limiting the vaccine's use to older adults, as well as possible
warnings about the potential clot risk, according to people
familiar with the matter.
The ACIP meeting is scheduled to begin at 11 a.m. Eastern time,
with a potential vote by 5 p.m.
It will be the ACIP's second emergency meeting in 10 days to
discuss the J&J vaccine. The committee, which advises the CDC,
met April 14, one day after use of J&J's vaccine was paused.
But the committee, meeting online, deferred voting on a
recommendation because members wanted more information about the
vaccine's risks and benefits.
European health regulators also have investigated the clot risk
and determined that vaccinations can proceed once J&J resumes
rolling out its vaccine there, but that product information should
carry a warning of the rare clot risk. The European Medicines
Agency said the benefits of the vaccine outweigh its risks.
J&J is updating its package information for the vaccine in
Europe to include details about the clot condition, and how to
identify and treat it.
Initially, six women between the ages of 18 and 48 were reported
to have clots in vessels that drain blood from the brain, combined
with low counts in the blood of platelets, which help with
clotting. That rare combination appeared to occur among J&J
vaccine recipients at a higher rate than what would be expected in
the general population, a CDC official said at the first ACIP
meeting. Health officials have since identified three more
At the time of last week's pause in vaccinations, more than
seven million people had received J&J's vaccine since it was
authorized for use in the U.S. in late February. A large study of
the single-dose vaccine showed it was about 66% effective at
preventing moderate-to-severe Covid-19 disease.
J&J has said it has been investigating the cases, and while
the clot condition is a potential risk, as of late last week
J&J said there wasn't sufficient evidence to establish that its
vaccine was causing the rare events.
The Food and Drug Administration authorized use of J&J's
vaccine in late February, the third Covid-19 shot to be cleared --
after shots from Pfizer Inc. with its partner BioNTech SE, and
Before the pause, J&J's vaccine made up a relatively small
portion of all available Covid-19 vaccine doses, as the company was
Still, public-health officials view the J&J vaccine as
particularly useful in vaccinating hard-to-reach populations, such
as the homebound and homeless. It doesn't require a second dose
like the Pfizer and Moderna vaccines do, and it can be stored in a
standard refrigerator for longer periods than the other
The company has a federal contract to supply about 100 million
doses of its vaccine for U.S. use by midyear. J&J has said it
is committed to supply that amount, but that production issues at a
contract manufacturer's plant in Baltimore could affect timing of
the delivery of doses. Production of J&J's vaccine at the plant
recently stopped during an FDA inspection, which identified
unsanitary conditions and other problems that must be
A significant issue that the ACIP might consider on Friday: how
the clot risk among J&J vaccine recipients stacks up against
the risk of clots that come with Covid-19 itself.
The risk of blood clots is much higher from Covid-19 disease
than from the vaccines associated with these complications, said
Jean Connors, a hematologist at Brigham and Women's Hospital in
Boston. Blood clotting all over the body is one complication of
severe forms of the disease. About 15% to 20% of Covid-19 patients
who are admitted to intensive-care units develop blood clots, Dr.
Use of the vaccine is even more urgent now with Covid-19 case
numbers rising rapidly in some other countries, such as India and
Brazil, she said. "The devastation due to Covid infection in these
countries is catastrophic," Dr. Connors said.
Cerebral venous sinus thrombosis -- blood clots in the brain --
alone affects five out of every one million people a year,
according to data cited by the American Heart Association. It is
far more common in women, and strikes most often in the third
decade of life, hematologists say.
The incidence of cerebral blood clots as a result of Covid-19,
on the other hand, is 39 for every one million people in the two
weeks after a Covid-19 diagnosis, according to a paper by Oxford
researchers that was posted on a preprint server, meaning that it
hasn't been peer-reviewed.
Awareness by physicians of the blood-clotting condition
associated with the vaccine and how to treat it quickly and
appropriately will help reduce illness and death from it, Dr.
Connors said. Four of the first six patients who developed clotting
and low platelets after vaccination were treated with heparin,
which can worsen their condition. Health authorities now say
nonheparin blood thinners should be used to treat these
"Now that we are aware of this syndrome, the risks of dying from
it are lower as we believe that we can more quickly identify those
that have it and treat it appropriately," Dr. Connors said.
Write to Peter Loftus at email@example.com and Betsy McKay at
(END) Dow Jones Newswires
April 23, 2021 05:44 ET (09:44 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.