Bharat Biotech Intranasal Vaccine (BBV154) for COVID-19 today received approval from the Drug Controller General of India to conduct Phase-III clinical trials. The trials will be conducted at nine locations in the country.
The trials will evaluate BBV154 nasal vaccine for both the 2 dose primary schedule and booster dose schedule. An intranasal vaccine as a booster will be easier to administer in mass vaccination drives.
Bharat Biotech has said that the nasal vaccine, BBV154, stimulates immune responses at the site of infection — the nose — and is very effective in blocking infection and transmission of Covid-19.
It has also underlined how easily a nasal vaccine can be administered and the fact that it would not need trained healthcare workers.
The Hyderabad-based vaccine manufacturer had last month sought the drug regulator’s approval to conduct phase-III trials of the nasal vaccine.
Bharat Biotech Intranasal Vaccine: The Phase III Trials of Intra-Nasal Vacine will evaluate both the second dose primary and booster dose schedule
The trials will evaluate BBV154 nasal vaccine for both the second dose primary schedule and booster dose schedule. Intranasal vaccines are easier to administer in mass immunization campaigns and help reduce and stop viral transmission.
The Phase-3 clinical trial should be conducted as per protocol multi-center study to compare immunogenicity and safety of BBV154 with Covaxin, according to a report.
For emergency use, safety data has to be given to the Drugs Controller General of India, or DCGI, within 15 days but for market approval, the data has to be given to the regulator within six months.
The market sale of the two vaccines was approved under the New Drugs and Clinical Trials Rules, 2019.
Covaxin maker Bharat Biotech and Covishield maker Serum Institute of India, or SII, had given data of ongoing clinical trials to the regulator, which approved the market sale after a subject expert committee on COVID-19 on January 19 recommended approval.