In
the
wake
of
a
controversial
executive
order
that
shrinks
the
number
of
universally
recommended
vaccines
for
children,
HHS
is
asking
the
public
to
weigh
in
on
whether
three
categories
used
in
federal
vaccine
recommendations
are
adequate.
The
three
categories
up
for
discussion
are
routine,
risk-based,
and
shared
clinical
decision-making.
The
agency
is
seeking
input
on
whether
it
should
implement
additional
or
different
categories.
The
request
for
information
posted
to
the
Federal
Register
asks
whether
the
currently
used
categories
“convey
meaningful
differences
in
the
strength
of
the
evidence,
the
magnitude
of
individual
and
population
benefit,
and
the
room
left
for
individual
circumstances
and
values,”
and
whether
they
“unintentionally
imply
that
parental
permission,
individual
consent,
or
meaningful
clinical
discussion
applies
only
to
shared
clinical
decision-making
recommendations.”
In
addition,
HHS
proposes
adding
additional
categories
of
recommendations
like
“recommended,
but
not
during
infancy,”
“recommended
with
qualification,”
and
“shared
clinical
decision-making
with
qualification.”
Moreover,
the
agency
inquires
about
the
potential
benefits
of
shared
clinical
decision-making,
including
“respect
for
autonomy,
informed
consent,
religious
conviction,
and
individualized
clinical
judgment,”
and
the
potential
risks
of
“confusion,
reduced
access
or
uptake,
and
time
burdens
in
practice.”
Richard
Hughes
IV,
JD,
the
attorney
representing
the
American
Academy
of
Pediatrics
in
its
lawsuit
against
HHS,
said
in
emailed
remarks
that
the
request
for
information,
“framed
as
an
open
inquiry,
is
anything
but.”
“Read
against
the
backdrop
of
the
administration’s
actions
in
vaccine
policy,
it
is
the
latest
step
in
a
predetermined
policy
agenda
to
restructure
the
federal
vaccine
recommendation
framework,
this
time
with
the
procedural
veneer
of
public
input,”
Hughes
said.
He
noted
that
the
development
of
the
shared
clinical
decision-making
category
was
developed
by
the
CDC’s
Advisory
Committee
on
Immunization
Practices
over
many
years
and
involved
considerable
deliberation.
“Under
the
guise
of
simply
requesting
information,
the
administration
is
now
making
clear
its
intent
to
modify
existing
recommendation
categories,
or
even
create
new
ones,”
Hughes
wrote.
The
request
for
information
also
floats
the
idea
that
recommendations
from
peer
agencies
abroad
should
be
incorporated
into
U.S.
guidance.
HHS
Secretary
Robert
F.
Kennedy
Jr.
has
previously
commented
on
President
Donald
Trump’s
wish
to
“align
the
U.S.
childhood
vaccine
schedule
with
international
consensus.”
It
also
puts
forward
considerations
for
setting
vaccine
recommendations.
“Commenters
are
specifically
invited
to
address
the
availability,
quality,
and
strength
of
evidence;
the
appropriate
approach
where
randomized
controlled
trial
evidence
is
absent,
infeasible,
or
unethical
to
obtain;
disease
severity
and
epidemiology;
individual
versus
population
benefit;
a
presumption
in
favor
of
individual
autonomy,
informed
consent,
and
religious
freedom;
and
feasibility
and
programmatic
consequences,”
the
document
stated.
Finally,
HHS
poses
questions
about
the
effects
of
vaccine
mandates
and
lessons
learned
from
vaccine
communications
during
the
COVID-19
pandemic.
It
remains
to
be
seen
exactly
how
HHS
will
use
the
responses
gathered
through
the
request
for
information.
Responses
are
due
by
Sept.
20.
Major
medical
organizations,
including
the
Infectious
Diseases
Society
of
America,
are
likely
to
submit
public
comments.
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