Moderna says FDA delayed RSV vaccine approval to end of May

Moderna
on
Friday
said
the
Food
and
Drug
Administration
has
delayed
the
approval
of
its

vaccine
for
respiratory
syncytial
virus
to
the
end
of
May
due
to “administrative
constraints”
at
the
agency.

The
FDA
was
expected
to
make
a
decision
on
the
RSV
shot
on
Sunday.
The
agency
has
not
informed
Moderna
of
any
issues
related
to
the
vaccine’s
safety,
efficacy
or
quality
that
would
prevent
its
approval,
the
biotech
company
said
in
a
release.

Investors
are
watching
the
upcoming
approval
closely
as
Moderna
tries
to
rebound
from
the
rapid
decline
of
its
Covid
business
last
year.
If
cleared,
the
RSV
shot
would
become
the
company’s
second
product
to
launch
in
the
U.S.
after
its
once-blockbuster
Covid
vaccine. It
would
also
be
the
third
RSV
vaccine
to
enter
the
market
after
shots
from


Pfizer
and


GSK
rolled
out
last
year.

Moderna
said
its
RSV
vaccine
is
still
on
track
to
be
reviewed
by
an
advisory
panel
to
the
Centers
for
Disease
Control
and
Prevention
during
a

meeting
on
June
26
and
27.
That
panel
will
vote
on
recommendations
for
the
shot’s
use
and
intended
population,
which
is
necessary
before
it
enters
the
market.

Moderna
has
been
testing
the
shot
in
older
adults,
who
are
more
vulnerable
to
severe
cases
of
RSV.
The
virus
kills
between
6,000
and
10,000
seniors
every
year
and
results
in
60,000
to
120,000
hospitalizations,
according
to
CDC
data.

“Moderna
is
very
grateful
to
the
FDA
for
their
continued
efforts
and
diligence,”
said
Dr.
Stephen
Hoge,
president
of
Moderna,
said
in
a
release. “We
look
forward
to
helping
the
agency
complete
the
review
of
our
application,
and
to
the
June
[advisory]
meeting.” 

The
approval
would
demonstrate
the
versatility
of
Moderna’s
messenger
RNA
platform
beyond
treating
Covid.
The
biotech
company
is
using
that
technology
to
tackle
a
range
of
diseases.
Those
include
RSV,
cancer
and
a
highly
contagious
stomach
bug
known
as
norovirus. 

Investors
have
high
hopes
for
the
long-term
potential
of
Moderna’s
mRNA
product
pipeline:
Shares
of
the
company
are
up
more
than
20%
this
year
after
falling
nearly
45%
in
2023.