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
Johnson & Johnson's Covid-19 vaccine in the U.S.
J&J's vaccine could be back in circulation as soon as this
weekend because millions of doses have already been distributed,
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.
"I do think that there's plenty of people who are interested in
the J&J vaccine, if just for convenience as well as for a
single-dose option," CDC Director Rochelle Walensky said at a White
House briefing before the day's actions.
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.
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.
(More to Come)
--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 19:45 ET (23:45 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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