Covid-19 intranasal vaccine Phase III trials over, proven safe

India

oi-Deepika S

Hyderabad,
Aug
15:
Bharat
Biotech’s
COVID-19
intranasal
vaccine
(BBV154)
has
proven
to
be
safe,
well-tolerated,
and
immunogenic
in
subjects
in
controlled
clinical
trials
phase
III.

The
vaccine
candidate
was
evaluated
earlier
in
phase
I
and
II
clinical
trials
with
successful
results.
BBV154
has
been
specifically
formulated
to
allow
intranasal
delivery.

In
addition,
the
nasal
delivery
system
has
been
designed
and
developed
to
be
cost-effective
in
low
and
middle-income
countries,
a
press
release
from
the
vaccine
maker
said.

BBV154
was
developed
in
partnership
with
Washington
University
St
Louis,
which
had
designed
and
developed
the
recombinant
adenoviral
vectored
constructs
and
evaluated
them
in
preclinical
studies
for
efficacy.
Product
development
related
to
pre-clinical
safety
evaluation,
large-scale
manufacturing
scale-up,
formulation,
and
delivery
device
development,
including
human
clinical
trials,
was
conducted
by
Bharat
Biotech.

The
Centre
partially
funded
product
development
and
clinical
trials
through
the
Department
of
Biotechnology’s,
COVID
Suraksha
programme.
Two
separate
and
simultaneous
clinical
trials
were
conducted
to
evaluate
BBV154
as
a
primary
dose
(2-dose)
schedule
and
a
heterologous
booster
dose
for
subjects
who
have
previously
received
2
doses
of
the
two
commonly
administered
Covid
vaccines
in
India.

Suchitra
K
Ella,
Joint
Managing
Director,
Bharat
Biotech,
said,
“On
this
Independence
Day,
we
are
proud
to
announce
successful
completion
of
clinical
trials
for
BBV154
intranasal
vaccine.
We
stay
committed
and
focused
on
innovation
and
product
development;
this
is
yet
another
achievement
for
the
multidisciplinary
teams
at
Bharat
Biotech.”

If
approved,
the
intranasal
vaccine
will
make
it
easier
to
deploy
in
mass
immunisation
campaigns
with
an
easy
to
administer
formulation
and
delivery
device,
she
further
said.

Primary
dose
schedule
phase
III
trials
were
conducted
for
safety,
and
immunogenicity
in
approximately
3,100
subjects,
and
compared
with
Covaxin.
The
trials
were
conducted
in
14
trial
sites
across
India.
Heterologous
booster
dose
studies
were
conducted
for
safety
and
immunogenicity
in
approximately
875
subjects,
where
a
booster
dose
(3rd
dose)
of
BBV154
intranasal
vaccine
was
administered
to
study
participants
who
were
previously
vaccinated
with
licensed
COVID
vaccines.
The
trials
were
conducted
in
9
trial
sites
across
India.