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Bharat Biotech Completes Phase 2/3 Trials Of Covaxin for Children Under 18 Years
Bharat Biotech has completed the Phase 2/3 trials of COVID-19 vaccine, Covaxin for use in children under 18 years of age and is expected to submit the data by next week to the DCGI, Chairman and Managing Director of Bharat Biotech International Ltd, Krishna Ella said on Tuesday here.
Speaking to reporters, he said Covaxin production would touch 55 million doses in October as against 35 million in September. He also said the Phase 2 trials of the firm's intranasal vaccine against COVID-19 is expected to be over by next month.
Paediatric Covaxin just completed phase 2/3 trials. The data analysis is going on. We will be submitting the data ( to the regulator) by next week. The number of subjects ( volunteers) is touching 1000, Ella said.
Intranasal immunization can create an immune response in the nose, which is the point of entry for the virusthereby protecting against the disease, infection, and transmission also, he noted.
According to Ella, the intranasal vaccine trials are conducted on three cohorts in which one group is administered Covaxin as the first dose and intranasal as the second. Similarly intranasal-intranasal for the second group and Intranasal- Covaxin for the third cohort, 28 days apart. He said the trials will be conducted on about 650 volunteers.
On the production levels of Covaxin, Ella said 100 million doses per month can be possible if the other manufacturing partners are fully geared up with safety and other parameters are in place. Other than its own facilities, Bharat Biotech has tied up with Indian Immunologiclas and Hester Biosciences, to manufacture Covaxin.
We
are
supplying
35
million
this
month.
Next
month
we
will
be
definitely
supplying
55
million
doses.
Production
at
Bangalore
is
catching
up
very
fast,
he
said
replying
to
a
query.
On
exports
of
Covaxin
to
other
countries,
Ella
said
if
the
Centre
permits,
the
firm
is
ready
to
export
the
jab,
though
the
firm
is
not
in
a
hurry
to
look
for
overseas
markets.
According
to
him,
the
government's
focus
is
to
fulfill
domestic
requirements.
India
will
resume
export
of
surplus
Covid-19
vaccines
in
the
fourth
quarter
of
2021
under
the
Vaccine
Maitri' programme
and
to
meet
its
commitment
to
the
COVAX
global
pool,
but
vaccinating
its
own
citizens
remains
the
topmost
priority
of
the
government,
Union
Health
Minister
Mansukh
Mandaviya
said
on
Monday.
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