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FDA OKs
Pfizer
COVID-19
Vaccine
For
12-15
Age
Group
By
Bill
Chappell
npr.org
WASHINGTON
- The
Food and
Drug
Administration
said
Monday
that
children
12 to 15
years
old are
now
eligible
to
receive
a key
COVID-19
vaccine
as the
agency
expanded
its
emergency
use
authorization
for the
Pfizer/BioNTech
vaccine.
Dr.
Janet
Woodcock,
the
acting
FDA
commissioner,
said the
expansion
"brings
us
closer
to
returning
to a
sense of
normalcy."
"Parents
and
guardians
can rest
assured
that the
agency
undertook
a
rigorous
and
thorough
review
of all
available
data, as
we have
with all
of our
COVID-19
vaccine
emergency
use
authorizations,"
Woodcock
said.
Until
now, the
Pfizer
vaccine
had been
authorized
only for
people
age 16
and
older.
Pfizer
asked
the FDA
to
broaden
its
emergency
use
authorization
for the
vaccine
after
announcing
in late
March
that
clinical
trials
found
"100%
efficacy
and
robust
antibody
responses"
in study
participants
who were
12 to
15.
The
FDA
first
granted
Pfizer's
request
for an
emergency
use
authorization
for its
COVID-19
vaccine
in
December.
It got
federal
approval
to
include
children
as young
as 12 in
its
vaccine
trial in
October.
All
three
makers
of
U.S.-authorized
vaccines
—
Pfizer,
Moderna
and
Johnson
&
Johnson
— are
studying
the
safety
and
effectiveness
of their
vaccines
in
children,
including
as young
as 6
months.
Johnson
&
Johnson
said
last
week
that its
vaccine
"will
initially
be
tested
in a
small
number
of
adolescents,
which
will be
expanded
to a
larger
group in
a
step-wise
approach,
if
initial
data
shows an
acceptable
safety
profile."
Those
expanded
trials
started
last
month
when J&J
vaccine
shots
were
given to
teens
from 16
to 17.
If all
goes
well,
the
trial
will
include
kids as
young as
12, the
company
said.
Moderna
said in
mid-April
that its
vaccine
study in
adolescents
is now
fully
enrolled,
with
around
3,000
people
ages 12
to 17
slated
to
receive
doses. A
second
phase of
the
study
will
follow,
including
children
who are
from 6
months
to 11
years
old.
Pfizer
said it
won't be
ready to
ask the
FDA for
new
emergency
use
authorization
expansions
for kids
younger
than 12
until
September.
One such
request
would
cover
children
from 2
to 5
years
old; a
second
would
apply to
ages 5
to 11. A
third
request,
aimed at
protecting
infants
and
toddlers,
isn't
expected
until
the
fourth
quarter
of this
year.
Pfizer
and
BioNTech
said
they
have the
capacity
to
manufacture
up to
2.5
billion
vaccine
doses in
2021,
and to
produce
at least
3
billion
doses in
2022.
In
another
move
that
could
boost
COVID-19
vaccine
availability,
Pfizer
recently
asked
the FDA
to
approve
a change
that
would
allow
its
vaccine
to be
stored
at
common
refrigerator
temperatures
of 2 to
8
degrees
Celsius
(roughly
36 to 46
degrees
Fahrenheit)
for up
to four
weeks.
The
company
said it
submitted
data
about
the
vaccine's
stability
at those
temperatures
on April
30.
In
general,
Pfizer's
vaccine
must be
stored
at
ultra-cold
temperatures
of
around
-70
degrees
Celsius
(-94
degrees
Fahrenheit).
The
company
loosened
that
requirement
a bit in
February,
however,
saying
the
shots,
which
use
messenger
RNA,
could
safely
be kept
at
typical
home
freezer
temperatures,
-25 to
-15
degrees
Celsius
(-13 to
5
degrees
Fahrenheit),
for up
to two
weeks.
The
COVID-19
vaccine's
success
has
brought
billions
of
dollars
to
Pfizer.
In the
first
quarter
of 2021
alone,
the
vaccine
added
$3.5
billion
in
global
revenue,
Pfizer
Chairman
and CEO
Albert
Bourla
told
investors
in a
conference
call
last
week.
Over the
entire
year,
Pfizer
could
bring in
around
$26
billion
based on
the
vaccine,
Bourla
said.
The
company
and
BioNTech,
its
development
and
revenue-sharing
partner,
have
shipped
some 430
million
doses to
91
countries
and
territories,
Bourla
said
last
week.
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