The Drugs Controller General of India (DCGI) gave its approval for phase 3 trials of Bharat Biotech’s intranasal booster dose for COVID-19 on Friday.
The trials will be conducted at nine locations in the country, according to news agency ANI.
The Hyderabad-based vaccine manufacturer behind India’s indigenous vaccine Covaxin, had proposed the nasal candidate, called BBV154, for ease of administration and its potential effectiveness in preventing COVID-19.
“BBV154 (nasal covid vaccine) has received approval for phase-3 clinical trials. The trials will evaluate BBV154 nasal vaccine for both the two-dose primary schedule and booster dose schedule,” company sources have said, according to PTI.
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The company aims to conduct trials on 5,000 healthy subjects, half of whom have received Covishield while the other half has taken Covaxin, Times of India reported, quoting a source.
The nasal dose is expected to be available by March. The gap between the second shot of the vaccine and the booster would be six months, according to reports.
The company had sought approval for the phase 3 trials last month.
Meanwhile, India’s drug regulator on Thursday granted regular market approval for COVID-19 vaccines Covishield and Covaxin for use in the adult population subject to certain conditions, official sources said.
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In an application sent to the DCGI, V Krishna Mohan, whole-time director at the Hyderabad-based Bharat Biotech, submitted complete information regarding chemistry, manufacturing and controls, along with the pre-clinical and clinical data while seeking regular market authorisation for Covaxin.
Bharat Biotech International Limited (BBIL) took up the challenge to develop, produce and clinically evaluate a vaccine (Covaxin), from the SARS-CoV-2 strains isolated from COVID-19 patients in India, Mohan had said in the application.
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Covaxin and Covishield were granted Emergency Use Authorisation (EUA) on January 3.