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The FDA Just Approved New COVID Shots. Here’s What Happens Now.

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The
Food
and
Drug
Administration
just
approved
new
COVID
shots,
as
cases
of
the
virus
start
to
creep
up
across
the
country.
Pharmaceutical
companies



Moderna
,


Pfizer


and



Novavax


all
announced
late
this
week
that
they
will
be
releasing
updated
vaccines
for
the
2026-2027
season.


Cases
of
COVID-19
are
increasing
in
most
states
after
a
relatively
quiet
summer,
according
to
data
from
the



Centers
for
Disease
Control
and
Prevention
.
The
test
positivity
rate
for
the
week
ending
Aug.
15
is
currently
close
to
5%

the
highest
it’s
been
since
February,
per
CDC
numbers.


A
few
things
have
changed
about
the
vaccines
from
previous
seasons,
including
some
potential
logistical
complications.
Infectious
disease
doctors
break
it
down.


What
are
the
updated
COVID
shots?


The
FDA
has
approved
these
updated
COVID
shots:


  • Spikevax
    .
    Moderna’s
    mRNA
    vaccine
    is
    approved
    for
    people
    aged
    6
    months
    through
    64
    who
    have
    an
    underlying
    health
    condition,
    the
    company
    announced
    in
    a



    press
    release


    Thursday.
    Anyone
    aged
    65
    and
    up
    also
    qualifies.

  • mNexspike
    .
    Another
    mRNA
    vaccine
    from
    Moderna,
    mNexspike
    is
    a
    lower-dose
    option.
    It’s
    approved
    for
    people
    aged
    12
    through
    64
    with
    an
    underlying
    condition,
    as
    well
    as
    those
    aged
    65
    and
    older.

  • Comirnaty
    .
    Pfizer’s
    mRNA
    vaccine
    has
    been
    approved
    for
    all
    adults
    aged
    65
    and
    older,
    per
    a
    company



    press
    release
    .
    Anyone
    aged
    5
    through
    64
    with
    an
    underlying
    condition
    that
    raises
    their
    risk
    of
    severe
    illness
    also
    qualifies.

  • Nuvaxovid
    .
    Produced
    by
    drugmakers
    Novavax
    and
    Sanofi,
    this
    is
    the
    only
    protein-based
    COVID
    vaccine
    in
    the
    United
    States.
    “This
    is
    a
    traditional-style
    vaccine,
    like
    the
    flu
    vaccine,”
    said
    Dr.



    Thomas
    Russo,


    a
    professor
    and
    chief
    of
    infectious
    diseases
    at
    the
    University
    at
    Buffalo
    in
    New
    York.


What
has
changed
from
previous
years?


The
vaccines
are
similar
to
previous
seasons.
However,
they
have
a
different
target.


Every
vaccine
this
cycle
targets
the
JN.1-lineage
XFG
variant,
the
same
way
flu
shots
get
re-targeted
every
year
based
on
what’s
circulating,”
said
Dr.



Amesh
A.
Adalja,


a
senior
scholar
at
the
Johns
Hopkins
Center
for
Health
Security.


What’s
different
from
many
previous
years
is
that
the
FDA
narrowed
eligibility
last
season
to
people
aged
65
and
older
or
with
a
high-risk
condition,
Adalja
explains.
“This
season’s
approvals
keep
that
line,”
he
said.


Getty
Images
New
COVID
shots
are
coming
out
this
fall,
but
distribution
and
eligibility
is
a
little
unclear.


Who
is
eligible
to
get
the
shot?


This
gets
slightly
complicated.
The
FDA’s
recommendations
heavily
favor
older
adults,
along
with
those
who
have
underlying
health
conditions,
known
as
comorbidities,
that
make
them
more
likely
to
develop
severe
illness
from
COVID-19.


“There
remains
some
uncertainty
about
eligibility
if
you
don’t
fall
into
those
groups,
but
the
comorbidities
are
broad,”
Russo
said.
The



list


includes
things
like
pregnancy
and
chronic
lung
disease,
along
with
less
obvious
conditions
like
depression
and
obesity.


Still,
doctors
say
you
should
be
able
to
get
vaccinated
if
you
want
the
shot.
“Anyone
who
wants
a
COVID
vaccine
will
be
able
to
get
one,”
Russo
said.
Adalja
agreed.
“Vaccines
are
available
off-label
outside
the
label
indication,”
he
said.


When
and
where
can
you
get
the
updated
COVID
vaccine?


These
vaccines
are
typically
shipped
out
“immediately”
after
they
receive
FDA
approval,
Adalja
said.
“If
you’re
high-risk,
get
it
now
as
COVID
activity
is
increasing
nationally,”
he
explained.
(It’s
a
good
idea
to
contact
your
provider
in
advance
to
make
sure
they’re
giving
the
most
up-to-date
vaccine.)


But
there’s
some
uncertainty
about

where

you’ll
be
able
to
get
the
vaccine.
While
many
doctors’
offices
will
stock
it,
some
states
need
vaccines
to
be
signed
off
by
the
CDC
before
they
can
be
given
in
pharmacies

a
common
place
where
adults
get
vaccinated,
Russo
points
out.


It’s
unclear
if
the
CDC’s
Advisory
Committee
on
Immunization
Practices
(ACIP),
which
was



dismantled


by
Health
and
Human
Services
Secretary
Robert
F.
Kennedy
Jr.
in
2025
and
replaced
with


handpicked
appointees,
will
weigh
in
on
the
vaccines.


While
mRNA
vaccines
have
been
controversial
in
the
past,
doctors
stress
their
value.


“The
mRNA
platform’s
advantage
is
speed,”
Adalja
said.
“When
a
variant
like
this
season’s
XFG
becomes
dominant,
manufacturers
can
redesign
and
produce
a
matched
shot
in
weeks
rather
than
the
months
conventional
manufacturing
requires.”


The
benefits
of
getting
vaccinated
with
any
COVID
vaccine
vary
by
risk,
Russo
said.
“The
greatest
benefit
is
in
high-risk
groups,”
he
explained.
“But
for
individuals
that
don’t
fall
into
those
groups
and
are
healthy,
it
still
has
benefits.”
Among
other
things,
the
vaccine
lowers
the
risk
of
developing
severe
disease
and
long
COVID.


“I
still
recommend
that
everyone
gets
vaccinated,”
Russo
said.
Adalja
echoed
this.
“What
these
vaccines
were
built
to
do

and
what
trial
and
real-world
data
still
show
they
do

is
prevent
severe
disease,
hospitalization,
and
death,”
he
noted.

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