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CDSCO expert panel to review Bharat Biotech's intranasal booster jab on November 15

CDSCO expert panel to review Bharat Biotech's intranasal booster jab on November 15

CDSCO expert panel to review Bharat Biotech's intranasal booster jab on November 15
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By Timsy Jaipuria  Nov 14, 2022 11:36:06 PM IST (Published)

The CDSCO expert panel will examine the proposal of Hyderabad-based Bharat Biotech seeking market authorisation for the nasal vaccine, according to multiple people familiar with the development.

The subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) will meet on Tuesday (November 15) to review the application of Bharat Biotech International's intranasal booster jab, sources privy to the developments told CNBC-TV18.

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The CDSCO expert panel will examine the proposal of Hyderabad-based Bharat Biotech seeking market authorisation for the nasal vaccine, according to multiple people familiar with the development.
In September, the Drugs Controller General of India (DCGI) approved Bharat Biotech’s intranasal COVID-19 vaccine for restricted emergency use in those aged above 18 years.
This is India's first intra-nasal COVID-19 vaccine which will be used for primary immunization against COVID-19 in the 18+ age group for restricted use in an emergency situation.
The company had completed clinical trials of the nasal vaccine with about 4,000 volunteers and there are no side effects or adverse reactions reported so far.
In August, it said its COVID-19 intranasal vaccine (BBV154) has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials phase -3.
BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine. 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, the vaccine maker had said.
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-19 vaccines – Covishield and Covaxin – in India.
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