By Peter Loftus
Vaccinations with Johnson & Johnson's Covid-19 shot should
resume, U.S. health regulators said after investigating rare
blood-clotting cases, restoring a key tool for filling gaps in the
mass vaccination campaign.
To alert doctors and recipients to the condition that led to a
pause in the vaccine's use last week, J&J and regulators plan
to add language to the shot's label and fact sheets warning of the
clotting condition risk.
The U.S. Food and Drug Administration and U.S. Centers for
Disease Control and Prevention on Friday lifted their
recommendation to pause use of the shots, saying the benefits
outweigh the risks. Their decision followed a vote by a federal
vaccine advisory committee that recommended restarting use of
J&J's Covid-19 vaccine in the U.S.
"This vaccine was shown to be safe and effective for the vast
majority of people," CDC Director Rochelle Walensky told reporters,
though she warned that some women might be at risk of the
blood-clotting condition.
J&J's vaccine should be back in circulation as soon as this
weekend, the FDA's vaccines chief Peter Marks said, ending a pause
that began last week and aiding some vaccination sites that
wrestled with limited supplies after the shot was pulled.
Its availability could ease supply constraints that have cropped
up since the pause at areas and vaccination sites that were
counting on J&J's vaccine. It could also fulfill demand among
people who prefer to get a single shot, rather than two doses
spaced weeks apart required for protection from the Pfizer Inc. and
Moderna Inc. vaccines.
"Some people want a one and done. Some people won't have access
to another vaccine in the near future," Dr. Walensky said.
Yet the back-and-forth over the vaccine's use could also prompt
some people concerned about safety to seek the other shots or even
avoid getting vaccinated. After the FDA and CDC recommended to
pause use of J&J's vaccine, health experts expressed concern
the move could exacerbate hesitancy to get vaccinated.
Dr. Walensky said the rate of the rare clot condition in J&J
vaccine recipients was about 1.9 cases per million people overall,
but 7 cases per million women ages 18 to 49 years. In women over
50, the case rate was 0.9 per million.
J&J has agreed with the FDA to add language to the vaccine's
label warning about the clot risk, J&J Chief Medical Officer
Joanne Waldstreicher told members of the vaccine committee during
its meeting.
Dr. Waldstreicher said resumption of vaccinations with J&J's
shot would likely prevent many more deaths and hospitalizations
from Covid-19 than the number of rare clot cases that may occur in
people receiving the vaccine.
"We believe the J&J Covid vaccine is central to the effort
to end the pandemic," Dr. Waldstreicher said.
A CDC official said that if vaccinations with J&J's shot
resumed, it could prevent up to 1,400 deaths from Covid-19 and up
to 3,500 admissions to hospital intensive-care units over a
six-month period, though there could be up to 45 cases of the rare
blood-clot condition.
"The benefits clearly outweigh the risks, though there are
differences in age groups, and particularly for women less than 50
years of age," said Dr. Katherine Poehling, a member of the
Advisory Committee on Immunization Practices that made the
recommendation, who is also a professor of pediatrics and
epidemiology at Wake Forest School of Medicine.
After the ACIP's vote, J&J said the committee vote was an
important step toward continuing vaccinations and the company will
collaborate with health authorities to ensure the clot condition
can be identified early and treated effectively.
J&J vaccine injections were put on hold after reports of a
rare blood-clot condition in a small number of recipients,
including at least three fatalities.
Many public-health authorities, however, contended that the
benefits of the vaccine outweigh the risks. The risk of blood clots
is much higher from Covid-19 disease than from the vaccines
associated with these complications, Jean Connors, a hematologist
at Brigham and Women's Hospital in Boston, said in an
interview.
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. Connors
said.
Earlier in the week, Europe's medicines regulator recommended
adding warning language to the J&J's shot, but said its
benefits outweighed its risks.
The ACIP advises the CDC on vaccines and includes doctors and
public-health officials. It voted 10 to 4, with one abstention in
favor of lifting the recommended pause and restarting use among all
adults following a six-hour meeting. It was the ACIP's second
emergency meeting in 10 days to discuss the J&J vaccine.
The committee met after authorities had identified a total of 15
cases of women experiencing blood clots combined with low
blood-platelet counts after receiving the J&J vaccine,
according to a presentation by a CDC official during Friday's ACIP
meeting. Three of the women have died.
Two of the cases were in women 50 and older, while the rest were
between 18 and 49 years of age. The symptoms, including severe
headaches and nausea, started around one to two weeks after
vaccination.
The CDC is calling the rare condition "thrombosis with
thrombocytopenia syndrome," or TTS.
Most of the women had blood clots in veins that drain blood from
the brain, but some had clots only in other parts of the body,
according to the CDC's presentation to the ACIP panel during its
meeting. The condition is also marked by low levels in the blood of
platelets, which play a role in clotting.
The CDC is investigating fewer than 10 potential additional
cases of TTS, Tom Shimabukuro, a CDC vaccine-safety official, said
during the ACIP meeting.
He also cited one case of a woman who experienced TTS and died,
but she was excluded from the case count partly because she also
had contracted Covid-19 after receiving the J&J vaccine.
Dr. Shimabukuro said the rare combination of clots with low
platelet counts is similar to cases that have been reported in
Europe among recipients of AstraZeneca PLC's Covid-19 vaccine. He
said this rare condition wasn't seen in people who received the
messenger RNA-based vaccines from Pfizer and Moderna.
Though the incidence of the clot risk appears low, some ACIP
members expressed concern about its seriousness. "It's not an
insignificant risk, " said committee member Pablo Sanchez, who is
also a pediatric infectious diseases specialist Nationwide
Children's Hospital in Columbus, Ohio. "It makes me nervous."
Some committee members wanted their recommendation to also state
that women under 50 should be aware of the clot risk and may choose
a different Covid-19 vaccine.
The FDA authorized use of J&J's vaccine in late February,
the third Covid-19 shot to be cleared -- after shots from Pfizer
with its partner BioNTech SE, and Moderna. J&J's vaccine was
cleared for people 18 years and older.
Before the pause, J&J's vaccine made up a relatively small
portion of all available Covid-19 vaccine doses, as the company
increased production. Nearly eight million doses of J&J's
vaccine had been administered at the time of the pause, according
to the CDC.
Still, public-health officials view the J&J vaccine as
particularly useful in vaccinating hard-to-reach populations, such
as the homebound and homeless.
In addition to requiring just one dose, it can be stored in a
standard refrigerator for longer periods than the other
vaccines.
Since J&J had distributed millions of doses before the
recommended pause, vaccination sites should have supplies readily
available.
FDA and CDC officials said they will continue to investigate the
rare blood-clotting condition, though they expressed confidence the
vaccine could be safely used.
Acting FDA Commissioner Janet Woodcock said authorities
initially recommended the pause because there was a "risk window"
in which many people had recently received J&J's vaccine and
authorities didn't know how many would develop the clot condition.
They also didn't know how many doctors would know how to recognize
the rare condition and treat it appropriately.
During the pause, authorities received information that
reassured them the number of cases wasn't large, and that doctors
were using the right treatments. "As we did this scientific
evaluation of recent days, I think we became more and more
confident about this decision today," Dr. Woodcock said.
J&J, of New Brunswick, N.J., 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 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.
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 non-heparin
blood thinners should be used.
"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.
The European Medicines Agency is probing the blood-clotting
condition among people who took the vaccine developed by
AstraZeneca and its partner, the University of Oxford.
The EMA said Friday the blood-clotting condition occurs in one
of every 100,000 people vaccinated with the AstraZeneca-Oxford
shot.
The incidence of the condition rises to 2.1 for every 100,000
people age 40 to 49, the age group most at risk, the EMA said, and
then drops to 1.1 for people 50 to 59 years and keeps falling as
people get older.
--Betsy McKay, Eric Sylvers and Tarini Parti contributed to this
article.
Write to Peter Loftus at peter.loftus@wsj.com
(END) Dow Jones Newswires
April 23, 2021 20:32 ET (00:32 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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