|
 The Centers for Disease Control and Prevention (CDC) and Food and
Drug Administration said the risks of experiencing the syndrome
involving severe blood clots and low platelets as a result of the
vaccine was very low. They found 15 cases in the 8 million shots
given.
"We are no longer recommending a pause in the use of this vaccine,"
CDC Director Rochelle Walensky told a news briefing. "Based on the
in-depth analysis, there is likely an association but the risk is
very low."
Top U.S. FDA officials said the decision was effective immediately,
clearing the way for shots in arms as early as Saturday. The agency
said it would warn of the risk in an updated fact sheet given to
vaccine recipients and providers.
The agencies made the decision following a meeting of outside
advisers to the CDC who recommended that the vaccine pause be ended.
In an analysis presented at the meeting, CDC staff said that the
cases of the syndrome that they had found occurred at a rate of
seven per one million doses in women under age 50, with the highest
risk occurring among women ages 30 to 39.
For women over age 50 and for all men, the clots appeared at a rate
of one per one million doses, the analysis showed. In all, there
were three deaths, officials said.
After a day-long meeting, the CDC panel voted 10-4 that the J&J
vaccine be used as recommended in people 18 years of age and older,
the parameters of its current FDA authorization.
Dr. Jesse Goodman, an infectious disease expert at Georgetown
University in Washington and a former chief scientist at the FDA,
said the risk was not trivial, but still small.
"But we should keep it in perspective. I mean the risk of dying from
a car accident in your life is something like one in 100, the risk
of being struck by lightning is something like one in 15,000,"
Goodman said.
Unlike the highly effective vaccines by Pfizer Inc and Moderna Inc,
which require two doses and must be kept frozen at ultra-cold
temperatures, J&J's vaccine can be given in a single dose and stored
at regular refrigeration temperatures, making it a better option for
hard-to-reach areas.
Johnson & Johnson shares closed up 0.2% at $165.52.
EARLY IDENTIFICATION
"We will collaborate with health authorities around the world to
educate healthcare professionals and the public to ensure this very
rare event can be identified early and treated effectively," J&J's
Chief Scientific Officer Paul Stoffels said in a statement after the
agencies made their announcement.
[to top of second column] |
 When the agencies first
announced the pause, they urged doctors to avoid
using the blood thinner heparin, commonly given
to patients to break up blood clots, in people
who had received the J&J vaccine and were
experiencing blood clots and low blood
platelets.
In the cases of the vaccine-induced blood clots,
however, heparin appears to make the condition
worse. Walensky said doctors heeded that
warning, noting that the drug had not been used
in any of the cases identified after the pause
began.
The U.S. decision follows a similar one by the
European Medicines Agency, which on Tuesday said
the benefits of the J&J shot outweighed its
risks and recommended adding a warning about
unusual blood clots with low blood platelet
counts to the vaccine's product label. J&J
resumed its rollout there.
The J&J probe followed an investigation in
Europe of the AstraZeneca PLC vaccine, with
which similar cases of blood clots were first
identified. Dr. Peter Marks of the FDA said the
cases appear so similar that a doctor would not
be able to tell which vaccine caused them.
Both the J&J and AstraZeneca vaccine use
different versions of a cold virus to deliver
instructions for making coronavirus proteins
into cells to produce an immune response. Marks
said studies are underway to determine whether
the adenovirus or something else is behind the
rare blood clots.
Dr. William Moss, executive director of the
International Vaccine Access Center at the Johns
Hopkins Bloomberg School of Public Health, said
the J&J vaccine will help advance the
vaccination effort.
"Giving people the choice to receive a
single-dose vaccine will help get more people
vaccinated faster and will better protect some
populations, such as those who are homeless or
incarcerated," Moss said by email.
J&J has faced several setbacks since its vaccine
gained U.S. emergency authorization in February,
including drawing scrutiny over production
shortfalls.
In the United States, 35% of adults are fully
vaccinated and 53% have received at least one
shot, according to CDC data. The United States
leads the world with roughly 570,000 COVID-19
deaths.
(Reporting by Manas Mishra in Bengaluru and
Julie Steenhuysen in Chicago; Additional
reporting by Kanishka Singh and Derek Francis in
Bengaluru, Susan Heavey in Washington, and Carl
O'Donnell in New York; Editing by Will Dunham,
Bill Berkrot and Caroline Humer)
[© 2021 Thomson Reuters. All rights
reserved.] Copyright 2021 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
Thompson Reuters is solely responsible for this content |
