By Peter Loftus
A federal vaccine advisory committee Friday recommended that use
of Johnson & Johnson's Covid-19 vaccine resume in the U.S.,
while J&J and regulators plan to add language to the product
label warning of the potential for a rare blood-clot condition.
If U.S. authorities follow the panel's recommendation, J&J's
vaccine could be back in circulation as soon as this weekend,
ending a pause that began last week and aiding some vaccination
sites that wrestled with limited supplies after the shot was
pulled.
"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.
The panel voted 10 to 4, with one abstention, in favor of
lifting the recommended pause and restarting use among all
adults.
J&J has agreed with the Food and Drug Administration 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 Centers for Disease Control and Prevention 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.
"Lifting the pause on J&J's vaccine is in the best
public-health interest of the U.S. population," said committee
member Henry Bernstein, who is also professor of pediatrics at the
Zucker School of Medicine at Hofstra/Northwell.
After the 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.
Agreement by the FDA and CDC to lift the pause could put the
vaccine back in circulation as early as this weekend, because
millions of doses have already been distributed to vaccine
sites.
Its availability could ease supply constraints that some areas
and vaccination sites counting on J&J's vaccine have
experienced since its use was paused. 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 vote.
Earlier in the week, Europe's medicines regulator recommended
adding warning language to J&J's shot, but said its benefits
outweighed its risks.
The Advisory Committee on Immunization Practices -- which
advises the CDC on vaccines and includes doctors and public-health
officials -- voted 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 April 14, one day after use of J&J's
vaccine was paused, but deferred voting on a recommendation because
members wanted more information about the vaccine's risks and
benefits.
The CDC has now 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 Friday 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.
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 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.
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 to treat these patients.
"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 PLC 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.
The agency also issued a new analysis detailing how the benefits
of vaccination grow with the increasing age of those getting
vaccinated and the infection rate of where they live.
--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 18:29 ET (22:29 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
AstraZeneca (NASDAQ:AZN)
Historical Stock Chart
Von Jun 2024 bis Jul 2024
AstraZeneca (NASDAQ:AZN)
Historical Stock Chart
Von Jul 2023 bis Jul 2024