Anaiya
Layland,
12,
receives
her
first
Pfizer
COVID-19
vaccination
as her
mother,
Ashlesha
Patel,
observes
at the
Cook
County
Public
Health
Department,
Thursday,
May 13,
2021, in
Des
Plaines,
Ill. (AP
Photo/Shafkat
Anowar) |
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The
findings
could
add
momentum
for
F.D.A.
authorization
of the
pediatric
dose,
perhaps
as early
as next
week, a
long-awaited
development
that
would
affect
28
million
children.
A
5-year-old
receiving
a
Pfizer-BioNTech
trial
dose
last
month.
(Credit...Shawn
Rocco/Duke
University,
via
Reuters) |
|
FDA Says
Pfizer
Vaccine’s
Benefits
Outweigh
Key
Risks in
Children
5 to 11
By
Sharon
LaFraniere,
Noah
Weiland
nytimes.com
WASHINGTON
—
Federal
regulators
evaluated
for the
first
time on
Friday
the
safety
and
efficacy
of a
coronavirus
vaccine
for
children
5 to 11,
saying
that the
benefits
of
staving
off
Covid-19
with the
Pfizer-BioNTech
vaccine
generally
outweighed
the
risks of
the most
worrisome
possible
side
effects
in that
age
group.
The
analysis
came on
the same
day that
the Food
and Drug
Administration
posted
data
from
Pfizer
showing
that the
vaccine
had a
90.7
percent
efficacy
rate in
preventing
symptomatic
Covid-19
in a
clinical
trial of
5- to
11-year-olds.
The
findings
could
add
momentum
for
F.D.A.
authorization
of the
pediatric
dose on
an
emergency
basis,
perhaps
as early
as next
week,
opening
up a
long-awaited
new
phase of
the
nation’s
vaccination
campaign.
The
agency’s
independent
vaccine
expert
committee
is set
to vote
Tuesday
on
whether
to
recommend
authorization.
In a
briefing
document
posted
on the
F.D.A.
website,
the
agency
said it
had
balanced
the
dangers
of
hospitalization,
death or
other
serious
consequences
from
Covid-19
against
the risk
of
myocarditis.
A rare
condition
involving
inflammation
of the
heart
muscle,
myocarditis
has been
linked
to the
Pfizer-BioNTech
and
Moderna
vaccines,
especially
among
young
men.
“The
overall
analysis
predicted
that the
numbers
of
clinically
significant
Covid-19-related
outcomes
prevented
would
clearly
outweigh
the
numbers
of
vaccine-associated
excess
myocarditis
cases,”
regulators
wrote.
As is
customary
before a
vote of
the
F.D.A.’s
advisory
committee,
the
regulators
took no
stance
on
whether
the new
use of a
vaccine
should
be
authorized.
If the
F.D.A.
rules in
favor of
authorization
and the
Centers
for
Disease
Control
and
Prevention
and its
own
panel of
vaccine
experts
agree,
the 28
million
children
in that
age
group
could
become
eligible
for
shots in
the
first
week of
November.
“There’s
a lot of
data to
be
encouraged
by,”
said Dr.
Kathryn
M.
Edwards,
a
professor
of
pediatrics
in the
division
of
infectious
diseases
at
Vanderbilt
University
School
of
Medicine.
She said
the
results
exceeded
the
protection
offered
by the
best flu
vaccine
and
could
eventually
lead to
the
easing
of
restrictions
intended
to
prevent
elementary
school
children
from
contracting
the
virus.
The
Biden
administration
has been
eagerly
promoting
the
prospect
of a
pediatric
shot,
and many
parents
are
anxiously
awaiting
the
development.
Covid-19
cases
among
those
younger
than 18
peaked
in the
first
week of
September,
when
nearly a
quarter
of a
million
cases
were
reported.
But they
have
remained
high,
with
more
than
130,000
cases
reported
in the
second
week of
October,
the
American
Academy
of
Pediatrics
said,
accounting
for a
quarter
of all
cases
nationwide.
Fewer
than two
percent
of those
cases
resulted
in
hospitalization,
but that
figure
was
based on
data
from
only
half the
states,
the
organization
said.
Pfizer
and
BioNTech
announced
a month
ago that
their
vaccine
worked
well for
young
children,
but no
comprehensive
clinical
data was
released
publicly
until
Friday.
Children
in the
trial
received
two
doses of
10
micrograms
—
one-third
of the
adult
dose —
three
weeks
apart.
Researchers
said
that the
dosage
was
safe,
and that
trial
participants
had seen
only
mild
side
effects.
Of 2,268
children
in the
trial,
twice as
many
were
given
the
vaccine
as
received
a
placebo.
Sixteen
children
who
received
the
placebo
got
Covid-19,
compared
with
three
who
received
the
vaccine.
All of
the
Covid
cases
occurred
in July
or
later,
as the
highly
transmissible
Delta
variant
was
spreading
in the
United
States
and
globally,
according
to the
company.
The
F.D.A.
said it
could
not
determine
whether
the
cases
were
caused
by the
Delta
variant.
Pfizer
said it
had
follow-up
safety
data for
an
additional
2,250
children,
but only
for a
median
of
two-and-a-half
weeks
after
they
received
a second
dose.
There
were no
cases of
severe
Covid
among
trial
participants,
and no
cases of
two rare
heart
conditions
that
have
been
linked
to the
vaccine
in
teenagers
and
adults,
especially
young
males.
But the
trial
was
likely
not big
enough
to
detect
whether
those
particular
conditions
—
myocarditis
and
pericarditis
— might
appear
with any
frequency
in
younger
children.
Minor
side
effects
in the
study
group
generally
occurred
more
frequently
after
the
second
dose,
the
F.D.A.
reported;
the most
common
were
pain at
the
injection
site,
fatigue
and
headache.
The
F.D.A.
modeled
different
scenarios
with
varying
levels
of viral
spread
to
determine
the
number
of
symptomatic
Covid
cases,
including
severe
ones,
that
would be
prevented
by the
vaccine.
They
balanced
that
against
the
risks
from
myocarditis
and
pericarditis
cases
associated
with
vaccination.
Even
given a
low rate
of Covid
infections,
they
said,
the
benefits
of
vaccination
could
outweigh
the
risks
because
the
virus
could
lead to
more
serious
health
consequences
than any
side
effects.
Researchers
looked
at
immune
responses,
comparing
them
with
levels
in
adults
who had
received
the
vaccine.
Pfizer
then
deduced
that the
protection
afforded
by the
lower
dose in
children
could be
as
substantial
as that
afforded
by the
higher
dose in
adults.
That
approach
is
particularly
important
in small
trials.
After
the
second
shot,
the
children
had
levels
of
neutralizing
antibodies
that
were at
least
equal to
those of
16-to-25-year-old
volunteers
in
another
Pfizer-BioNTech
trial.
Although
antibody
levels
are just
one
measure
of the
immune
system’s
response,
experts
have
said
such a
finding
would
indicate
that
one-third
of an
adult
dose was
the
proper
dosage
for
young
children.
What to
Know
About
Covid-19
Booster
Shots
The
F.D.A.
has
authorized
booster
shots
for
millions
of
recipients
of the
Pfizer-BioNTech,
Moderna
and
Johnson
&
Johnson
vaccines.
Pfizer
and
Moderna
recipients
who are
eligible
for a
booster
include
people
65 and
older,
and
younger
adults
at high
risk of
severe
Covid-19
because
of
medical
conditions
or where
they
work.
Eligible
Pfizer
and
Moderna
recipients
can get
a
booster
at least
six
months
after
their
second
dose.
All
Johnson
&
Johnson
recipients
will be
eligible
for a
second
shot at
least
two
months
after
the
first.
Yes. The
F.D.A.
has
updated
its
authorizations
to allow
medical
providers
to boost
people
with a
different
vaccine
than the
one they
initially
received,
a
strategy
known as
“mix and
match.”
Whether
you
received
Moderna,
Johnson
&
Johnson
or
Pfizer-BioNTech,
you may
receive
a
booster
of any
other
vaccine.
Regulators
have not
recommended
any one
vaccine
over
another
as a
booster.
They
have
also
remained
silent
on
whether
it is
preferable
to stick
with the
same
vaccine
when
possible.
The
C.D.C.
has said
the
conditions
that
qualify
a person
for a
booster
shot
include:
hypertension
and
heart
disease;
diabetes
or
obesity;
cancer
or blood
disorders;
weakened
immune
system;
chronic
lung,
kidney
or liver
disease;
dementia
and
certain
disabilities.
Pregnant
women
and
current
and
former
smokers
are also
eligible.
The
F.D.A.
authorized
boosters
for
workers
whose
jobs put
them at
high
risk of
exposure
to
potentially
infectious
people.
The
C.D.C.
says
that
group
includes:
emergency
medical
workers;
education
workers;
food and
agriculture
workers;
manufacturing
workers;
corrections
workers;
U.S.
Postal
Service
workers;
public
transit
workers;
grocery
store
workers.
Yes. The
C.D.C.
says the
Covid
vaccine
may be
administered
without
regard
to the
timing
of other
vaccines,
and many
pharmacy
sites
are
allowing
people
to
schedule
a flu
shot at
the same
time as
a
booster
dose.
Studies
have
shown
that the
risk of
developing
myocarditis
or
pericarditis
from
Covid-19
is
higher
than
from
vaccination.
Still,
some
countries
have
recommended
a single
dose of
the
Pfizer-BioNTech
vaccine
for
children
12 and
older,
offering
less
protection
but
possibly
with a
lower
risk of
side
effects.
Experts
will
almost
certainly
raise
concerns
about
those
side
effects
at the
F.D.A.
advisory
committee
meeting,
according
to Dr.
H. Cody
Meissner,
a member
of the
panel
and the
chief of
the
Division
of
Pediatric
Infectious
Diseases
at Tufts
Children’s
Hospital
in
Boston.
“I
certainly
hope
that
we’re in
a
position
to to
recommend
this
because
people
are
certainly
waiting
for it,
they’re
anxious
to have
it,” he
said.
“But our
responsibility
is to
balance
both
risk and
benefit.”
Vaccine
experts
have
said
that
Pfizer’s
lower
dosing
could
mitigate
risks.
“We
always
like to
use the
least
amount
of
vaccine
that’s
needed
to
generate
an
immune
response,”
Dr.
Edwards,
the
Vanderbilt
expert,
said,
“because
it’s
generally
associated
with
fewer
adverse
events.”
Dr.
Brian
Feingold,
an
expert
on heart
inflammation
in
children
at the
UPMC
Children’s
Hospital
of
Pittsburgh,
said
that,
“If you
just
focus on
myocarditis
or other
potentially
rare
things,
you’re
probably
still
going to
be left
wanting
more
information.”
But “we
cannot
consider
a risk
in
isolation,”
he
added.
“Risks
from
Covid
need to
be
considered
when you
make a
decision
about
whether
this
vaccine
has
greater
net
benefit.”
Dr.
Edwards
said
that
researchers
and
regulators
were in
a
quandary.
“The
more
people
that you
that you
enroll,
the more
time
that it
takes,”
she
said. “A
lot of
times,
in order
to
really
look at
the data
for very
rare
events,
you’re
not
going to
be able
to do
that in
studies
until
the
vaccine
is
really
used
more
broadly.”
The
Centers
for
Disease
Control
and
Prevention,
which
sets
vaccine
policy
for the
government,
has
scheduled
a
meeting
of its
advisory
committee
for Nov.
2 and 3
to
consider
the
issue.
Federal
officials
have
said
they
intend
to ship
15
million
doses to
the
states
immediately
if
regulatory
and
health
officials
authorize
the
move.
The
needles
that
administer
the
vaccine
and the
vials
that
hold it
will
need to
be
smaller
for
children
who are
still
largely
in
elementary
school.
About 17
million
adolescents
aged 12
to 15
became
eligible
for the
Pfizer-BioNTech
vaccine
in May.
Vaccine
manufacturers
continue
to study
the
possibility
of a
vaccine
for
those
aged six
months
to 5
years
old.
Only
about
one in
three
parents
of 5- to
11-year-olds
planned
to get
their
children
inoculated
“right
away”
once a
vaccine
is
authorized,
according
to
polling
by the
Kaiser
Family
Foundation
conducted
last
month.
Another
third
said
they
wanted
to “wait
and see”
how the
vaccine
affected
children.
But that
same
polling
showed
that
reluctance
among
parents
of
teenagers
had
dropped
in the
months
since
vaccines
became
available
to that
age
group.
Aina J.
Khan
contributed
reporting
from
London,
and Carl
Zimmer
from New
Haven,
Conn.
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