The Drug Controller General of India today gave the go-ahead for the Phase-III trials
Vaccine manufacturer Bharat Biotech has received approval to conduct Phase-III clinical trials of an intranasal booster dose on people who have received both doses of Covaxin. The Drug Controller General of India today gave the go-ahead for the Phase-III trials. The trials will be conducted at nine locations in the country.
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.
The trials will evaluate BBV154 nasal vaccine for both the second dose primary schedule and booster dose schedule. Intra nasal vaccines are easier to administer in mass immunization campaigns and help reduce and stop viral transmission.
The fresh approval comes soon after Bharat Biotech's Covaxin and Serum Institute of India's Covishield were cleared for sale in the market. This, however, doesn't mean the two vaccines will be available at shops soon. While people would be able to buy them from hospitals and clinics, details on this are awaited.
For emergency use, safety data has to be given 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.