The Hyderabad-based firm completed clinical trials of the nasal vaccine with about 4,000 volunteers and there is no side effect or adverse reaction reported so far, company sources had said.
India's drug regulator has given permission to Bharat Biotech to conduct phase-3 clinical trial for its intranasal Covid vaccine as booster dose on participants who have been previously inoculated with SARS-CoV 2 vaccines.
The company said it had conducted two separate trials for its intranasal Covid vaccine, one as a primary dose schedule and another as a booster dose, for subjects who have been double vaccinated with the two commonly administered Covid vaccines in India.
The first nasal vaccine against COVID-19, developed by Bharat Biotech, has received regulator's nod for conducting phase 2 clinical trials, the Department of Biotechnology said on Friday.
The vaccine would not have production scalability issues unlike Covaxin, Bharat Biotech's COVID-19 virus vaccine.
The needle-free vaccine will be available at private centres.
An intranasal vaccine as a booster dose would be easier to administer in mass vaccination campaigns and has the potential to prevent transmission.
A back of the envelope calculation shows that India has roughly over 680 million doses of Covid-19 vaccines consisting primarily of Covishield doses.
'We seem to be in a situation where we can do little, and nothing needs to be done anyway.'
A nasal vaccine, one expert said, is a "fantastic idea" for two reasons -- one, it can potentially create sterile immunity, and two, it is easy to administer and thus scalable.
The panel also recommended giving approval to Bharat Biotech for carrying out a study on interchangeability of its Covaxin and the under-trial adenoviral intranasal vaccine candidate BBV154, but asked the Hyderabad-based firm to remove the word "interchangeability" from the study title and submit a revised protocol for approval.
Bharat Biotech is targeting to manufacture one billion doses of its intra-nasal vaccine in 2022 which is under clinical trials now.
Bharat Biotech applied to the Drugs Controller General of India (DCGI) seeking permission for conducting phase 1 and phase 2 clinical trials of the intranasal vaccine following which the subject expert committee of the CDSCO on Tuesday deliberated on the application and recommended granting permission for phase 1 trial.
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