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Joint
CDC and
FDA
Statement
on
Johnson
&
Johnson
COVID-19
Vaccine
The
following
statement
is
attributed
to Dr.
Anne
Schuchat,
Principal
Deputy
Director
of the
CDC and
Dr.
Peter
Marks,
director
of the
FDA’s
Center
for
Biologics
Evaluation
and
Research
ATLANTA,
GA - As
of April
12, more
than 6.8
million
doses of
the
Johnson
&
Johnson
(Janssen
)
vaccine
have
been
administered
in the
U.S. CDC
and FDA
are
reviewing
data
involving
six
reported
U.S.
cases of
a rare
and
severe
type of
blood
clot in
individuals
after
receiving
the J&J
vaccine.
In these
cases, a
type of
blood
clot
called
cerebral
venous
sinus
thrombosis
(CVST)
was seen
in
combination
with low
levels
of blood
platelets
(thrombocytopenia).
All six
cases
occurred
among
women
between
the ages
of 18
and 48,
and
symptoms
occurred
6 to 13
days
after
vaccination.
Treatment
of this
specific
type of
blood
clot is
different
from the
treatment
that
might
typically
be
administered.
Usually,
an
anticoagulant
drug
called
heparin
is used
to treat
blood
clots.
In this
setting,
administration
of
heparin
may be
dangerous,
and
alternative
treatments
need to
be
given.
CDC
will
convene
a
meeting
of the
Advisory
Committee
on
Immunization
Practices
(ACIP)
on
Wednesday
to
further
review
these
cases
and
assess
their
potential
significance.
FDA will
review
that
analysis
as it
also
investigates
these
cases.
Until
that
process
is
complete,
we are
recommending
a pause
in the
use of
this
vaccine
out of
an
abundance
of
caution.
This is
important,
in part,
to
ensure
that the
health
care
provider
community
is aware
of the
potential
for
these
adverse
events
and can
plan for
proper
recognition
and
management
due to
the
unique
treatment
required
with
this
type of
blood
clot.
Right
now,
these
adverse
events
appear
to be
extremely
rare.
COVID-19
vaccine
safety
is a top
priority
for the
federal
government,
and we
take all
reports
of
health
problems
following
COVID-19
vaccination
very
seriously.
People
who have
received
the J&J
vaccine
who
develop
severe
headache,
abdominal
pain,
leg
pain, or
shortness
of
breath
within
three
weeks
after
vaccination
should
contact
their
health
care
provider.
Health
care
providers
are
asked to
report
adverse
events
to the
Vaccine
Adverse
Event
Reporting
System
at
https://vaers.hhs.gov/reportevent.html.
CDC and
FDA will
provide
additional
information
and
answer
questions
later
today at
a media
briefing.
A
recording
of that
media
call
will be
available
on the
FDA’s
YouTube
channel.
U.S.
DEPARTMENT
OF
HEALTH
AND
HUMAN
SERVICES
CDC
works
24/7
protecting
America’s
health,
safety
and
security.
Whether
disease
start at
home or
abroad,
are
curable
or
preventable,
chronic
or
acute,
or from
human
activity
or
deliberate
attack,
CDC
responds
to
America’s
most
pressing
health
threats.
CDC is
headquartered
in
Atlanta
and has
experts
located
throughout
the
United
States
and the
world.
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