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FDA says
J&J
1-dose
shot
prevents
COVID;
final
decision
soon
By
LAURAN
NEERGAARD
and
MATTHEW
PERRONE
apnews.com
WASHINGTON
-
Johnson
&
Johnson’s
single-dose
vaccine
protects
against
COVID-19,
according
to an
analysis
by U.S.
regulators
Wednesday
that
sets the
stage
for a
final
decision
on a new
and
easier-to-use
shot to
help
tame the
pandemic.
The
Food and
Drug
Administration’s
scientists
confirmed
that
overall
the
vaccine
is about
66%
effective
at
preventing
moderate
to
severe
COVID-19.
The
agency
also
said
J&J’s
shot —
one that
could
help
speed
vaccinations
by
requiring
just one
dose
instead
of two —
is safe
to use.
That’s
just one
step in
the
FDA’s
evaluation
of a
third
vaccine
option
for the
U.S. On
Friday,
the
agency’s
independent
advisers
will
debate
if the
evidence
is
strong
enough
to
recommend
the
long-anticipated
shot.
Armed
with
that
advice,
FDA is
expected
to make
a final
decision
within
days.
The
vaccination
drive
has been
slower
than
hoped,
hampered
by
logistical
issues
and
weather
delays
even as
the
country
mourns
more
than
500,000
virus-related
deaths.
So far,
about
44.5
million
Americans
have
received
at least
one dose
of
vaccine
made by
Pfizer
or
Moderna,
and
nearly
20
million
have
received
the
second
dose
required
for full
protection.
J&J
tested
its
single-dose
option
in
44,000
people
in the
U.S.,
Latin
America
and
South
Africa.
Different
mutated
versions
of the
virus
are
circulating
in
different
countries,
and the
FDA
analysis
cautioned
that
it’s not
clear
how well
the
vaccine
works
against
each
variant.
But J&J
previously
announced
the
vaccine
worked
better
in the
U.S. --
72%
effective
against
moderate
to
severe
COVID-19,
compared
with 66%
in Latin
America
and 57%
in South
Africa.
Still,
in every
country
it was
highly
effective
against
the most
serious
symptoms,
and
early
study
results
showed
no
hospitalizations
or
deaths
starting
28 days
after
vaccination.
While
the
overall
effectiveness
numbers
may
suggest
the J&J
candidate
isn’t
quite as
strong
as
two-dose
competitors,
all of
the
world’s
COVID-19
vaccines
have
been
tested
differently,
making
comparisons
nearly
impossible.
While it
wouldn’t
be
surprising
if one
dose
turns
out to
be a
little
weaker
than two
doses,
policymakers
will
decide
if
that’s
an
acceptable
trade-off
to get
more
people
vaccinated
faster.
J&J
was on
track to
become
the
world’s
first
one-dose
option
until
earlier
this
month,
Mexico
announced
it would
use a
one-dose
version
from
China’s
CanSino.
That
vaccine
is made
with
similar
technology
as J&J’s
but
initially
was
developed
as a
two-dose
option
until
beginning
a
one-dose
test in
the
fall.
The
rival
Pfizer
and
Moderna
vaccines
being
used in
the U.S.
and
numerous
other
countries
must be
kept
frozen,
while
the J&J
shot can
last
three
months
in the
refrigerator,
making
it
easier
to
handle.
AstraZeneca’s
vaccine,
widely
used in
Europe,
Britain
and
Israel,
is made
similarly
and also
requires
refrigeration
but
takes
two
doses.
If
the FDA
clears
the J&J
shot for
U.S.
use, it
won’t
boost
vaccine
supplies
significantly
right
away.
Only a
few
million
doses
are
expected
to be
ready
for
shipping
in the
first
week.
But J&J
told
Congress
this
week
that it
expected
to
provide
20
million
doses by
the end
of March
and 100
million
by
summer.
European
regulators
and the
World
Health
Organization
also are
considering
J&J’s
vaccine.
Worldwide,
the
company
aims to
be
producing
around a
billion
doses by
the end
of the
year.
___
The
Associated
Press
Health
and
Science
Department
receives
support
from the
Howard
Hughes
Medical
Institute’s
Department
of
Science
Education.
The AP
is
solely
responsible
for all
content.
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